chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Foetal exposure during pregnancy, Haemangioma
Clinical narrative: Case number PHHY2012DE047844 is an initial literature report received on 16 May 2012. Authors performed a controlled observational prospective cohort study on H1N1 vaccine safety in pregnancy. This case refers to a baby (sex not specified) born to a 35-year-old mother. The mother was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) at 29 weeks and 4 days of gestation (see linked mother file: PHHY2012DE047843). The baby was exposed to these vaccines via trans-placental route. At 42 weeks of gestation the baby was born and presented with hemagioma (1.5 x 3 cm x 1 mm) in right wrist. The seriousness and causality was not reported. Authors concluded that there was no indication yet for any unwanted effect of H1N1-vaccination to the pregnant woman or the unborn. However, lack of evidence of increased risk might not be interpreted as evidence of no risk. Larger studies were needed to confirm the anticipated safety of immunization during pregnancy.
Age: 20.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Antibody test negative, Blood culture positive, Complement factor decreased, Death, Meningococcal sepsis
Clinical narrative: Initial report received from scientific literature on 30 May 2012. The following is verbatim from the article abstract: "A 20-y-old male presented with symptoms of meningococcal sepsis and died despite appropriate medical interventions. Blood cultures grew N. meningitidis serogroup Y. The patient had received the meningococcal quadrivalent (A,C,W-135,Y) polysaccharide vaccine 15 mo previously. Because the patient had a history of meningococcal meningitis at age 10, archived serum was obtained for further analysis. Complement component C7 was found to be deficient, and antibody levels to meningococcal polysaccharides were undetectable for two serogroups and low for the infecting serogroup 10 mo post-vaccination. This case highlights the fact that some individuals with terminal complement component deficiencies mount an impaired or short-lived response to vaccination with meningococcal capsular polysaccharides, and underscores the appropriateness of a more aggressive vaccination strategy in this patient population." The patient's outcome was fatal. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Neisseria test positive
Clinical narrative: Initial report received from scientific literature on 30 May 2012. The following is verbatim from the article abstract: "A 20-y-old male presented with symptoms of meningococcal sepsis and died despite appropriate medical interventions. Blood cultures grew N. meningitidis serogroup Y. The patient had received the meningococcal quadrivalent (A,C,W-135,Y) polysaccharide vaccine 15 mo previously. Because the patient had a history of meningococcal meningitis at age 10, archived serum was obtained for further analysis. Complement component C7 was found to be deficient, and antibody levels to meningococcal polysaccharides were undetectable for two serogroups and low for the infecting serogroup 10 mo post-vaccination. This case highlights the fact that some individuals with terminal complement component deficiencies mount an impaired or short-lived response to vaccination with meningococcal capsular polysaccharides, and underscores the appropriateness of a more aggressive vaccination strategy in this patient population." The patient's outcome was fatal. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Activated partial thromboplastin time prolonged, Blood creatinine increased, Blood culture positive, Blood pH decreased, Blood product transfusion
Clinical narrative: Initial report received from scientific literature on 30 May 2012. The following is verbatim from the article abstract: "A 20-y-old male presented with symptoms of meningococcal sepsis and died despite appropriate medical interventions. Blood cultures grew N. meningitidis serogroup Y. The patient had received the meningococcal quadrivalent (A,C,W-135,Y) polysaccharide vaccine 15 mo previously. Because the patient had a history of meningococcal meningitis at age 10, archived serum was obtained for further analysis. Complement component C7 was found to be deficient, and antibody levels to meningococcal polysaccharides were undetectable for two serogroups and low for the infecting serogroup 10 mo post-vaccination. This case highlights the fact that some individuals with terminal complement component deficiencies mount an impaired or short-lived response to vaccination with meningococcal capsular polysaccharides, and underscores the appropriateness of a more aggressive vaccination strategy in this patient population." The patient's outcome was fatal. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Blood thromboplastin increased, Chills, Complement factor C3, Complement factor C4 decreased, Complement factor decreased
Clinical narrative: Initial report received from scientific literature on 30 May 2012. The following is verbatim from the article abstract: "A 20-y-old male presented with symptoms of meningococcal sepsis and died despite appropriate medical interventions. Blood cultures grew N. meningitidis serogroup Y. The patient had received the meningococcal quadrivalent (A,C,W-135,Y) polysaccharide vaccine 15 mo previously. Because the patient had a history of meningococcal meningitis at age 10, archived serum was obtained for further analysis. Complement component C7 was found to be deficient, and antibody levels to meningococcal polysaccharides were undetectable for two serogroups and low for the infecting serogroup 10 mo post-vaccination. This case highlights the fact that some individuals with terminal complement component deficiencies mount an impaired or short-lived response to vaccination with meningococcal capsular polysaccharides, and underscores the appropriateness of a more aggressive vaccination strategy in this patient population." The patient's outcome was fatal. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Death, Disseminated intravascular coagulation, Endotracheal intubation, Haemodialysis, Haemorrhage intracranial
Clinical narrative: Initial report received from scientific literature on 30 May 2012. The following is verbatim from the article abstract: "A 20-y-old male presented with symptoms of meningococcal sepsis and died despite appropriate medical interventions. Blood cultures grew N. meningitidis serogroup Y. The patient had received the meningococcal quadrivalent (A,C,W-135,Y) polysaccharide vaccine 15 mo previously. Because the patient had a history of meningococcal meningitis at age 10, archived serum was obtained for further analysis. Complement component C7 was found to be deficient, and antibody levels to meningococcal polysaccharides were undetectable for two serogroups and low for the infecting serogroup 10 mo post-vaccination. This case highlights the fact that some individuals with terminal complement component deficiencies mount an impaired or short-lived response to vaccination with meningococcal capsular polysaccharides, and underscores the appropriateness of a more aggressive vaccination strategy in this patient population." The patient's outcome was fatal. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Headache, Meningococcal sepsis, Myalgia, Nausea, Neisseria test positive
Clinical narrative: Initial report received from scientific literature on 30 May 2012. The following is verbatim from the article abstract: "A 20-y-old male presented with symptoms of meningococcal sepsis and died despite appropriate medical interventions. Blood cultures grew N. meningitidis serogroup Y. The patient had received the meningococcal quadrivalent (A,C,W-135,Y) polysaccharide vaccine 15 mo previously. Because the patient had a history of meningococcal meningitis at age 10, archived serum was obtained for further analysis. Complement component C7 was found to be deficient, and antibody levels to meningococcal polysaccharides were undetectable for two serogroups and low for the infecting serogroup 10 mo post-vaccination. This case highlights the fact that some individuals with terminal complement component deficiencies mount an impaired or short-lived response to vaccination with meningococcal capsular polysaccharides, and underscores the appropriateness of a more aggressive vaccination strategy in this patient population." The patient's outcome was fatal. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Photophobia, Platelet count decreased, Prothrombin time prolonged, Pyrexia, Rash macular
Clinical narrative: Initial report received from scientific literature on 30 May 2012. The following is verbatim from the article abstract: "A 20-y-old male presented with symptoms of meningococcal sepsis and died despite appropriate medical interventions. Blood cultures grew N. meningitidis serogroup Y. The patient had received the meningococcal quadrivalent (A,C,W-135,Y) polysaccharide vaccine 15 mo previously. Because the patient had a history of meningococcal meningitis at age 10, archived serum was obtained for further analysis. Complement component C7 was found to be deficient, and antibody levels to meningococcal polysaccharides were undetectable for two serogroups and low for the infecting serogroup 10 mo post-vaccination. This case highlights the fact that some individuals with terminal complement component deficiencies mount an impaired or short-lived response to vaccination with meningococcal capsular polysaccharides, and underscores the appropriateness of a more aggressive vaccination strategy in this patient population." The patient's outcome was fatal. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Respiratory distress, Viral infection, Vomiting, White blood cell count normal
Clinical narrative: Initial report received from scientific literature on 30 May 2012. The following is verbatim from the article abstract: "A 20-y-old male presented with symptoms of meningococcal sepsis and died despite appropriate medical interventions. Blood cultures grew N. meningitidis serogroup Y. The patient had received the meningococcal quadrivalent (A,C,W-135,Y) polysaccharide vaccine 15 mo previously. Because the patient had a history of meningococcal meningitis at age 10, archived serum was obtained for further analysis. Complement component C7 was found to be deficient, and antibody levels to meningococcal polysaccharides were undetectable for two serogroups and low for the infecting serogroup 10 mo post-vaccination. This case highlights the fact that some individuals with terminal complement component deficiencies mount an impaired or short-lived response to vaccination with meningococcal capsular polysaccharides, and underscores the appropriateness of a more aggressive vaccination strategy in this patient population." The patient's outcome was fatal. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL
Symptoms: Blood pressure increased, Body temperature decreased, Dizziness, Electrocardiogram, Fatigue
Clinical narrative: Pt given vaccines - went to front desk to pay & c/o nausea. Pt moved to clinic room, pt rested. After 35 minutes pt c/o dizziness, sweating, nausea, cold. 911 called. EKG done. Pt still c/o dizziness, sweating, nausea & cold & seemed disoriented. Pt transported to hospital for further evaluation.
Age: 47.0
Sex: F
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL
Symptoms: Heart rate increased, Presyncope, Pyrexia
Clinical narrative: Pt given vaccines - went to front desk to pay & c/o nausea. Pt moved to clinic room, pt rested. After 35 minutes pt c/o dizziness, sweating, nausea, cold. 911 called. EKG done. Pt still c/o dizziness, sweating, nausea & cold & seemed disoriented. Pt transported to hospital for further evaluation.
Age: 47.0
Sex: F
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL
Symptoms: Disorientation, Dizziness, Electrocardiogram normal, Feeling cold, Hyperhidrosis
Clinical narrative: Pt given vaccines - went to front desk to pay & c/o nausea. Pt moved to clinic room, pt rested. After 35 minutes pt c/o dizziness, sweating, nausea, cold. 911 called. EKG done. Pt still c/o dizziness, sweating, nausea & cold & seemed disoriented. Pt transported to hospital for further evaluation.
Age: 47.0
Sex: F
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL
Symptoms: Nausea
Clinical narrative: Pt given vaccines - went to front desk to pay & c/o nausea. Pt moved to clinic room, pt rested. After 35 minutes pt c/o dizziness, sweating, nausea, cold. 911 called. EKG done. Pt still c/o dizziness, sweating, nausea & cold & seemed disoriented. Pt transported to hospital for further evaluation.
Age: 60.0
Sex: M
Vaccine: FLU(H1N1), VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Anti-SS-A antibody positive, Anti-SS-B antibody positive, Antinuclear antibody positive, Arthralgia
Clinical narrative: Information has been received from a 62 year old male patient reporting on himself with drug reaction/allergy to TOFRANIL, PLAQUENIL and trazodone hydrochloride who on 03-DEC-2009, was vaccinated with a dose of ZOSTAVAX (Merck) 0.65ml, SC (lot number 664351/0958Y, expiration date 09-JAN-2011). Concomitant therapy included amlodipine, atenolol, COUMADIN, lisinopril (manufacturer unknown), lovastatin (manufacturer unknown), metformin, omeprazole, fluoxetine, AMBIEN, prednisone and quinacrine. It was reported that on 14-MAR-2010, the patient broke out in a bad photosensitive rash on all part of the body exposed to the sun: neck, face, scalp, forearms and chest. The consumer stated that he started getting tired all of the time and muscles and joints would ache. He also reported that he generally did not feel well. The patient was diagnosed with systemic and "subcutaneous" lupus and Sjogren's syndrome. The consumer stated that he "now avoided sunshine due to photosensitive rash". "Steroid cream and medications" were given as treatment for the adverse events. On an unknown date, punch biopsy was taken and "diagnosed with possible lupus". The patient went to see a rheumatologist and a dermatologist. At the time of the report, the patient's outcome was not recovered. Upon internal review, systemic lupus was determined to be an other important medical event. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLU(H1N1), VARZOS, VARZOS
Symptoms: Autoimmune disorder, Blood test, Cutaneous lupus erythematosus, Decreased appetite, Dry eye
Clinical narrative: Information has been received from a 62 year old male patient reporting on himself with drug reaction/allergy to TOFRANIL, PLAQUENIL and trazodone hydrochloride who on 03-DEC-2009, was vaccinated with a dose of ZOSTAVAX (Merck) 0.65ml, SC (lot number 664351/0958Y, expiration date 09-JAN-2011). Concomitant therapy included amlodipine, atenolol, COUMADIN, lisinopril (manufacturer unknown), lovastatin (manufacturer unknown), metformin, omeprazole, fluoxetine, AMBIEN, prednisone and quinacrine. It was reported that on 14-MAR-2010, the patient broke out in a bad photosensitive rash on all part of the body exposed to the sun: neck, face, scalp, forearms and chest. The consumer stated that he started getting tired all of the time and muscles and joints would ache. He also reported that he generally did not feel well. The patient was diagnosed with systemic and "subcutaneous" lupus and Sjogren's syndrome. The consumer stated that he "now avoided sunshine due to photosensitive rash". "Steroid cream and medications" were given as treatment for the adverse events. On an unknown date, punch biopsy was taken and "diagnosed with possible lupus". The patient went to see a rheumatologist and a dermatologist. At the time of the report, the patient's outcome was not recovered. Upon internal review, systemic lupus was determined to be an other important medical event. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLU(H1N1), VARZOS, VARZOS
Symptoms: Fatigue, Malaise, Myalgia, Photosensitivity reaction, Quality of life decreased
Clinical narrative: Information has been received from a 62 year old male patient reporting on himself with drug reaction/allergy to TOFRANIL, PLAQUENIL and trazodone hydrochloride who on 03-DEC-2009, was vaccinated with a dose of ZOSTAVAX (Merck) 0.65ml, SC (lot number 664351/0958Y, expiration date 09-JAN-2011). Concomitant therapy included amlodipine, atenolol, COUMADIN, lisinopril (manufacturer unknown), lovastatin (manufacturer unknown), metformin, omeprazole, fluoxetine, AMBIEN, prednisone and quinacrine. It was reported that on 14-MAR-2010, the patient broke out in a bad photosensitive rash on all part of the body exposed to the sun: neck, face, scalp, forearms and chest. The consumer stated that he started getting tired all of the time and muscles and joints would ache. He also reported that he generally did not feel well. The patient was diagnosed with systemic and "subcutaneous" lupus and Sjogren's syndrome. The consumer stated that he "now avoided sunshine due to photosensitive rash". "Steroid cream and medications" were given as treatment for the adverse events. On an unknown date, punch biopsy was taken and "diagnosed with possible lupus". The patient went to see a rheumatologist and a dermatologist. At the time of the report, the patient's outcome was not recovered. Upon internal review, systemic lupus was determined to be an other important medical event. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLU(H1N1), VARZOS, VARZOS
Symptoms: Rash generalised, Sjogren's syndrome, Subcutaneous biopsy abnormal, Systemic lupus erythematosus, Tremor
Clinical narrative: Information has been received from a 62 year old male patient reporting on himself with drug reaction/allergy to TOFRANIL, PLAQUENIL and trazodone hydrochloride who on 03-DEC-2009, was vaccinated with a dose of ZOSTAVAX (Merck) 0.65ml, SC (lot number 664351/0958Y, expiration date 09-JAN-2011). Concomitant therapy included amlodipine, atenolol, COUMADIN, lisinopril (manufacturer unknown), lovastatin (manufacturer unknown), metformin, omeprazole, fluoxetine, AMBIEN, prednisone and quinacrine. It was reported that on 14-MAR-2010, the patient broke out in a bad photosensitive rash on all part of the body exposed to the sun: neck, face, scalp, forearms and chest. The consumer stated that he started getting tired all of the time and muscles and joints would ache. He also reported that he generally did not feel well. The patient was diagnosed with systemic and "subcutaneous" lupus and Sjogren's syndrome. The consumer stated that he "now avoided sunshine due to photosensitive rash". "Steroid cream and medications" were given as treatment for the adverse events. On an unknown date, punch biopsy was taken and "diagnosed with possible lupus". The patient went to see a rheumatologist and a dermatologist. At the time of the report, the patient's outcome was not recovered. Upon internal review, systemic lupus was determined to be an other important medical event. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLU(H1N1), VARZOS, VARZOS
Symptoms: Vertigo
Clinical narrative: Information has been received from a 62 year old male patient reporting on himself with drug reaction/allergy to TOFRANIL, PLAQUENIL and trazodone hydrochloride who on 03-DEC-2009, was vaccinated with a dose of ZOSTAVAX (Merck) 0.65ml, SC (lot number 664351/0958Y, expiration date 09-JAN-2011). Concomitant therapy included amlodipine, atenolol, COUMADIN, lisinopril (manufacturer unknown), lovastatin (manufacturer unknown), metformin, omeprazole, fluoxetine, AMBIEN, prednisone and quinacrine. It was reported that on 14-MAR-2010, the patient broke out in a bad photosensitive rash on all part of the body exposed to the sun: neck, face, scalp, forearms and chest. The consumer stated that he started getting tired all of the time and muscles and joints would ache. He also reported that he generally did not feel well. The patient was diagnosed with systemic and "subcutaneous" lupus and Sjogren's syndrome. The consumer stated that he "now avoided sunshine due to photosensitive rash". "Steroid cream and medications" were given as treatment for the adverse events. On an unknown date, punch biopsy was taken and "diagnosed with possible lupus". The patient went to see a rheumatologist and a dermatologist. At the time of the report, the patient's outcome was not recovered. Upon internal review, systemic lupus was determined to be an other important medical event. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLU(H1N1), VARZOS, VARZOS
Symptoms: Arthralgia, Biopsy skin abnormal, Cutaneous lupus erythematosus, Fatigue, Malaise
Clinical narrative: Information has been received from a 62 year old male patient reporting on himself with drug reaction/allergy to TOFRANIL, PLAQUENIL and trazodone hydrochloride who on 03-DEC-2009, was vaccinated with a dose of ZOSTAVAX (Merck) 0.65ml, SC (lot number 664351/0958Y, expiration date 09-JAN-2011). Concomitant therapy included amlodipine, atenolol, COUMADIN, lisinopril (manufacturer unknown), lovastatin (manufacturer unknown), metformin, omeprazole, fluoxetine, AMBIEN, prednisone and quinacrine. It was reported that on 14-MAR-2010, the patient broke out in a bad photosensitive rash on all part of the body exposed to the sun: neck, face, scalp, forearms and chest. The consumer stated that he started getting tired all of the time and muscles and joints would ache. He also reported that he generally did not feel well. The patient was diagnosed with systemic and "subcutaneous" lupus and Sjogren's syndrome. The consumer stated that he "now avoided sunshine due to photosensitive rash". "Steroid cream and medications" were given as treatment for the adverse events. On an unknown date, punch biopsy was taken and "diagnosed with possible lupus". The patient went to see a rheumatologist and a dermatologist. At the time of the report, the patient's outcome was not recovered. Upon internal review, systemic lupus was determined to be an other important medical event. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLU(H1N1), VARZOS, VARZOS
Symptoms: Myalgia, Photosensitivity reaction, Sjogren's syndrome, Systemic lupus erythematosus
Clinical narrative: Information has been received from a 62 year old male patient reporting on himself with drug reaction/allergy to TOFRANIL, PLAQUENIL and trazodone hydrochloride who on 03-DEC-2009, was vaccinated with a dose of ZOSTAVAX (Merck) 0.65ml, SC (lot number 664351/0958Y, expiration date 09-JAN-2011). Concomitant therapy included amlodipine, atenolol, COUMADIN, lisinopril (manufacturer unknown), lovastatin (manufacturer unknown), metformin, omeprazole, fluoxetine, AMBIEN, prednisone and quinacrine. It was reported that on 14-MAR-2010, the patient broke out in a bad photosensitive rash on all part of the body exposed to the sun: neck, face, scalp, forearms and chest. The consumer stated that he started getting tired all of the time and muscles and joints would ache. He also reported that he generally did not feel well. The patient was diagnosed with systemic and "subcutaneous" lupus and Sjogren's syndrome. The consumer stated that he "now avoided sunshine due to photosensitive rash". "Steroid cream and medications" were given as treatment for the adverse events. On an unknown date, punch biopsy was taken and "diagnosed with possible lupus". The patient went to see a rheumatologist and a dermatologist. At the time of the report, the patient's outcome was not recovered. Upon internal review, systemic lupus was determined to be an other important medical event. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Dizziness, Vision blurred
Clinical narrative: Approximately 1 hour after administration, patient complained of dizziness, blurred vision.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling of thigh - injection site - with redness - tenderness started a few hours after injection. Given prednisone & BENADRYL.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Local reaction in (L) upper arm of erythema & increased warmth with some edema, tennis ball sized in diameter. Tx: BENADRYL/CLARITIN with hydrocortisone cream topically.
Age: 25.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Acne, Burning sensation, Fatigue, Headache, Injection site pain
Clinical narrative: Redness, swelling at injection site w/isolated red papular generally distributed.
Age: 25.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site reaction, Pain, Pruritus, Pyrexia, Rash erythematous
Clinical narrative: Redness, swelling at injection site w/isolated red papular generally distributed.
Age: 25.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Vaccination site warmth
Clinical narrative: Redness, swelling at injection site w/isolated red papular generally distributed.
Age: 25.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Rash papular
Clinical narrative: Redness, swelling at injection site w/isolated red papular generally distributed.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site urticaria, Pruritus
Clinical narrative: Hives at injection site pt itching, BP 98/65 P108 T98.5.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Dizziness, Headache, Rash, Seizure like phenomena, Syncope
Clinical narrative: CHILD BECAME DIZZY THEN FAINTED WITH LIKE A SEIZURE. DEVELOPED A HEADACHE AND RASH THAT DAY. WAS DIZZY ON AND OFF SEVERAL DAYS AFTER INJECTION.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Type III immune complex mediated reaction
Clinical narrative: Patient had softball size red swollen reaction at site of injection with quarter size darker red hard kast at site. KEFLEX 500 mg TID x 7 days. Arthus reaction.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis Dx at hospital ER by MD.
Age: 1.54
Sex: F
Vaccine: HEPA
Symptoms: Chest X-ray normal, Convulsion, Febrile convulsion, Gram stain negative, Pulmonary congestion
Clinical narrative: Received Hep A vaccine at clinic 6-7-12. Was in day 8/10 of OMNICEF for pneumonia. Symptoms had resolved. On 6-8-12 began with fever and congestion. That night had about 5 min CT seizure. ED Dx: febrile sz. CXR (-) UA gm stain (-).
Age: 1.54
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Received Hep A vaccine at clinic 6-7-12. Was in day 8/10 of OMNICEF for pneumonia. Symptoms had resolved. On 6-8-12 began with fever and congestion. That night had about 5 min CT seizure. ED Dx: febrile sz. CXR (-) UA gm stain (-).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever, H/A, S/A, pain in feet, dizzy, pt. slept 16 hours symptoms reported verbally by mother over phone 6-7-12 recommended office visit to be seen by doctor pt. refused care, follow-up call 6-8-12 pt. still refused care mom to monitor symptoms. Follow up call 6-11-12 pt. better.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain
Clinical narrative: Verbal report of painful blistering to both inner arms, chest, (L) buttocks, patient to be evaluated by PCP office today.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Abnormal behaviour, Aggression, Blood follicle stimulating hormone normal, Blood luteinising hormone normal, Blood prolactin normal
Clinical narrative: Received DTaP #5 & IPV #4 on 5/4/12, then on 5/6/12 presented to local ER with lg local rxn vs cellulitis & given KEFLEX severe behavior outbursts & tantrums noted during this time & lasted 3 1/2 wks. Seen in office 5/18/12 with multiple labs checked & neg/nl. Mom worried about "encephalopathy"
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Blood testosterone normal, Cellulitis, Dehydroepiandrosterone test, Differential white blood cell count normal, Full blood count normal
Clinical narrative: Received DTaP #5 & IPV #4 on 5/4/12, then on 5/6/12 presented to local ER with lg local rxn vs cellulitis & given KEFLEX severe behavior outbursts & tantrums noted during this time & lasted 3 1/2 wks. Seen in office 5/18/12 with multiple labs checked & neg/nl. Mom worried about "encephalopathy"
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Local reaction, Metabolic function test normal, Serum ferritin normal, Thyroid function test normal
Clinical narrative: Received DTaP #5 & IPV #4 on 5/4/12, then on 5/6/12 presented to local ER with lg local rxn vs cellulitis & given KEFLEX severe behavior outbursts & tantrums noted during this time & lasted 3 1/2 wks. Seen in office 5/18/12 with multiple labs checked & neg/nl. Mom worried about "encephalopathy"
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Slight fever - red neck 1st day 4" long 1" wide red swollen welt at inj. site lasting 3 days. Hot to touch, no itching.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Slight fever - red neck 1st day 4" long 1" wide red swollen welt at inj. site lasting 3 days. Hot to touch, no itching.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Crying, Cyanosis, Gaze palsy, Loss of consciousness, Pyrexia
Clinical narrative: Child went to day care after clinic appt. Day care called mother that afternoon to report that child was running fever and that he held his breath until he lost consciousness (maybe a minute). Lips turned blue. While unconsciousness, was shaking. Eyes rolled back in head. Was crying and upset when he woke up. Mother reported all of this through what the day care reported to her. Was not with child when event happened. Mom stated he had fever but uncertain of number. Gave TYLENOL. Spoke with mother on 6/7/12. States that patient has had no more episodes and is doing good. No more fever.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Tremor
Clinical narrative: Child went to day care after clinic appt. Day care called mother that afternoon to report that child was running fever and that he held his breath until he lost consciousness (maybe a minute). Lips turned blue. While unconsciousness, was shaking. Eyes rolled back in head. Was crying and upset when he woke up. Mother reported all of this through what the day care reported to her. Was not with child when event happened. Mom stated he had fever but uncertain of number. Gave TYLENOL. Spoke with mother on 6/7/12. States that patient has had no more episodes and is doing good. No more fever.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Rec varicella vaccine x 9 days ago. Started with redness and swelling at the site x 3 days ago. Also with low grade fever x 3 days. Advice of TYLENOL for fever, prn and BENADRYL w/warm compress.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Paraesthesia, Rash
Clinical narrative: Severe stiff neck, rash, tingling in neck. The event started 1-2012 - ongoing treatment calamine lotion. Doc says I have the shingles? Why!
Age: 22.0
Sex: F
Vaccine: HEPA, IPV, MNQ, YF
Symptoms: Calcium deficiency, Hypokalaemia, Influenza like illness, Magnesium deficiency, Malaise
Clinical narrative: Flu like symptoms with fever.  Vomiting malaise. Symptoms continued through to the 14th when mother called office - Patient referred immediately to Emergency room.  Patient was hospitalized at Medical Center x 6 days.  Following endocrine consult-found that parathyroid was not operating properly causing deficiencies in Calcium, Potassium, and Magnesium.  Patient also needing to take Vitamin D.
Age: 22.0
Sex: F
Vaccine: HEPA, IPV, MNQ, YF
Symptoms: Parathyroid disorder, Pyrexia, Vitamin D deficiency, Vomiting
Clinical narrative: Flu like symptoms with fever.  Vomiting malaise. Symptoms continued through to the 14th when mother called office - Patient referred immediately to Emergency room.  Patient was hospitalized at Medical Center x 6 days.  Following endocrine consult-found that parathyroid was not operating properly causing deficiencies in Calcium, Potassium, and Magnesium.  Patient also needing to take Vitamin D.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: Patient started to get a chicken-pox like rash up her left arm and back on the Thursday following her vaccination.  It was itchy and she took Benadryl to help with it.  The rash was more prominant on her back.
Age: 54.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration
Clinical narrative: Redness, itching, induration at vaccine site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Headache, Pruritus, Pyrexia
Clinical narrative: 5/28 Pt noticed itching, then redness a day or two later. Pt had low grade fever & headaches. Pt noticed blisters 6/2 when she decided to go see the Dr got VALTREX prescribed.
Age: 0.51
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Clostridium test positive, Culture stool positive, Ileus
Clinical narrative: Patient has history of Hirschsprungs with surgical repair. Given the ROTATEQ on 4/30/12 was admitted with Ileus on 5/4/12 - Discharged 5/5/12 positive C-diff on stool test.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: (L) arm pain with referral down arm.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient received ZOSTAVAX or 6/5/12, left arm returned to clinic 6/7/12 with extreme redness at site raised, firm to touch, very hot to touch. Treated with BACTRIM DS one po BID x 10 days, and pt instructed to take MOTRIN po which she did not take. Returned to clinic 6/8/12 site, appears improved, photo taken.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash through the body start the day MMR, Varicella, PREVNAR13 and DTaP were given.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: Large area of erythema & induration both vaccine sites ((R) & (L) arms) from vaccine site to > 1/2 distance to elbow. No difficulty with respiration or ill feeling.
Sex: U
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Polymerase chain reaction
Clinical narrative: Initial report was received 31 May 2012 from a health care professional which involved a cluster of approximately 17 patients (six elderly patients, two adolescent patients and approximately nine unidentified patients) who tested PCR positive for influenza A/H3 since January. This case captures information for two adolescent patients. The six elderly patients have been captured in case number 2012-05658 and the remaining unidentified patients (approximately nine) have been captured in case number 2012-05660. A cluster of two adolescent patients had received FLUZONE, lot number UT499AA (route, site and dates of administration not reported), and an unspecified amount of time later, the patients tested PCR positive for influenza A/H3 at the state laboratory. Outcomes were not reported. No additional information was provided at the time of the report. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Polymerase chain reaction
Clinical narrative: Initial report was received 31 May 2012 from a health care professional which involved a cluster of approximately 17 patients (six elderly patients, two adolescent patients and approximately nine unidentified patient(s) who tested PCR positive for influenza A/H3 since January. This case captures information for six elderly patients. The two adolescent patients have been captured in case number 2012-05659 and the approximately nine unidentified patients have been captured in case number 2012-05660. A cluster of six elderly patients had received FLUZONE, lot number UH454AC (route, site and dates of administration not reported), and an unspecified amount of time later, the patients tested PCR positive for influenza A/H3 at the state laboratory. Outcomes were not reported. No additional information was provided at the time of the report. Documents held by sender: None.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Headache, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a consumer concerning her daughter in law who on 04-JUN-2012 was vaccinated with her first dose of GARDASIL (lot # not reported). The reporter was very upset that her stepdaughter a senior in high school, had had syncope, "passed out," and a seizure while still in the doctor's office after receiving the vaccine on 04-JUN-2012. The caller reported that the physician did not think the symptoms were related to the vaccination. On 05-JUN-2012, the child had a "terrible headache" and needed to leave school and return home. The doctor had recommended that the child sought a neurologist but the reporter was asking why. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 1.51
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 30 May 2012 from the Investigator participating in the post-marking study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3579AA received on 19 February 2010, lot number C3591AA received on 15 April 2010 and lot number C3579AA received on 16 June 2010 and 1 dose of DAPTACEL; lot number C3577AA received on 17 June 2011 (routes and sites of administration not reported). The subject developed a cough on 30 April 2012, approximately 10 months after the last dose and a paroxysmal cough without whoop on 02 May 2012. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 17 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 17 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 21 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.51
Sex: M
Vaccine: DTAP
Symptoms: Sleep disorder
Clinical narrative: Initial report received on 30 May 2012 from the Investigator participating in the post-marking study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3579AA received on 19 February 2010, lot number C3591AA received on 15 April 2010 and lot number C3579AA received on 16 June 2010 and 1 dose of DAPTACEL; lot number C3577AA received on 17 June 2011 (routes and sites of administration not reported). The subject developed a cough on 30 April 2012, approximately 10 months after the last dose and a paroxysmal cough without whoop on 02 May 2012. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 17 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 17 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 21 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.61
Sex: F
Vaccine: DTAP
Symptoms: Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 30 May 2012 from the Investigator participating in the post-marking study under the reference number M5A16. A case of pertussis disease in a three-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C2881AA received on 23 March 2009, lot number C3304AA received on 16 June 2009 and lot number C3579AA received on 25 February 2010 and 1 dose of DAPTACEL; lot number C3157AA received on 24 August 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 04 May 2012, approximately one year and eight months after the last dose. On 08 May 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 14 May 2012. Corrective treatments consisted of azithromycin starting on 16 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 24 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.61
Sex: F
Vaccine: DTAP
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 30 May 2012 from the Investigator participating in the post-marking study under the reference number M5A16. A case of pertussis disease in a three-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C2881AA received on 23 March 2009, lot number C3304AA received on 16 June 2009 and lot number C3579AA received on 25 February 2010 and 1 dose of DAPTACEL; lot number C3157AA received on 24 August 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 04 May 2012, approximately one year and eight months after the last dose. On 08 May 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 14 May 2012. Corrective treatments consisted of azithromycin starting on 16 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 24 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sex: U
Vaccine: RAB
Symptoms: Anaphylactic reaction
Clinical narrative: Initial report was received from a health care professional through an affiliate on 30 May 2012 under local reference number 1-380197298. A patient (age, date of birth and gender not reported) had received a dose of RABIES VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later the patient experienced an anaphylactic reaction. The patient also had an anaphylactic reaction to MMR vaccine. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Grand mal convulsion, Loss of consciousness, Respiratory arrest, Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who on 30-MAY-2012 was vaccinated with the first 0.5mL dose of GARDASIL (lot# 672834/0131AE). It was reported that on 30-MAY-2012 the patient fainted. She came back to and passed out again and she stopped breathing for a few seconds until she came back again. The physician reported that the patient felt woozy after 30 seconds of GARDASIL being given. The patient also stopped breathing but recovered within 10 minutes. The physician specified that the patient not only had a syncopal episode but stated there was tonic clonic movement involved. It was also reported that less than one minute after the vaccination, the patient experienced a syncopal episode and a tonic clonic seizure. The physician stated that on 30-MAY-2012 the syncopal episode and seizure lasted less than two minutes. No treatment was administered. After stopping the therapy, the adverse events improved. The physician stated that the patient was fully recovered before she left the office on 30-MAY-2012 (also reported the patient was called at home and said she was fine). Upon internal review, the stopped breathing and the tonic clonic seizure were determined to be other important medical events. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Tonic clonic movements
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who on 30-MAY-2012 was vaccinated with the first 0.5mL dose of GARDASIL (lot# 672834/0131AE). It was reported that on 30-MAY-2012 the patient fainted. She came back to and passed out again and she stopped breathing for a few seconds until she came back again. The physician reported that the patient felt woozy after 30 seconds of GARDASIL being given. The patient also stopped breathing but recovered within 10 minutes. The physician specified that the patient not only had a syncopal episode but stated there was tonic clonic movement involved. It was also reported that less than one minute after the vaccination, the patient experienced a syncopal episode and a tonic clonic seizure. The physician stated that on 30-MAY-2012 the syncopal episode and seizure lasted less than two minutes. No treatment was administered. After stopping the therapy, the adverse events improved. The physician stated that the patient was fully recovered before she left the office on 30-MAY-2012 (also reported the patient was called at home and said she was fine). Upon internal review, the stopped breathing and the tonic clonic seizure were determined to be other important medical events. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN
Symptoms: Dyspnoea, Pruritus, Urticaria, Wheezing
Clinical narrative: Difficulty breathing/wheezing 4 hrs after vaccine - did not see a health provider for it. Rash appears. 24 hrs later - urticarial with itching.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN
Symptoms: Lip swelling, Rash, Vomiting, Wheezing
Clinical narrative: Difficulty breathing/wheezing 4 hrs after vaccine - did not see a health provider for it. Rash appears. 24 hrs later - urticarial with itching.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Rash
Clinical narrative: Patient from doctor's office called the pharmacy to report that the patient had developed cellulitis, she received the vaccine on 6/9/12, the patient seeked medical attention on 6/11/12. Patient also reported that this was due to the vaccine being given in the wrong in the wrong place ie approximately 1" above the elbow. She was given an antibiotic. Patient also developed a possible shingles rash on right cheek.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Activated partial thromboplastin time normal, Blood fibrinogen normal, Differential white blood cell count normal, Discomfort, Full blood count normal
Clinical narrative: 10 days post vaccination, developed measles-like rash (maculo-papular) that begin on extremities and groin and spread centrally. Rash was pruritic and uncomfortable. No other symptoms.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Prothrombin time normal, Rash maculo-papular, Rash morbilliform, Rash pruritic
Clinical narrative: 10 days post vaccination, developed measles-like rash (maculo-papular) that begin on extremities and groin and spread centrally. Rash was pruritic and uncomfortable. No other symptoms.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient was given ZOSTAVAX injection 9-18-09 - pt was seen & diagnosed with shingles 06/11/12. Pt is currently on dose of Prednisone for 6 days. Took 2 days.