chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Feeling hot, Flow cytometry, Hepatic enzyme, Hyperthermia, Injection site erythema
Clinical narrative: Initial physician report received on 01 Dec 2010: This patient with unknown medical history was vaccinated with MENVEO in the left deltoid muscle on 09 Nov 2010. In the evening of 09 Nov 2010, the patient developed erythema with itching at injection site. On 10 Nov 2010, she noticed severe swelling in left upper arm with local feeling of both hyperthermia and tension. The above did not experience any deterioration of the general condition and fever was explicitly denied. Evidently on the same day, the patient presented at the hospital and was admitted. On admission, the patient was differentially diagnosed with vaccination reaction in left upper arm, and analysis of (potentially) beginning infection. The patient was in good general and nutritional condition. Gross clinical and gross neurological examination did not reveal any pathological findings, but the axillary nodes of left side were slightly enlarged. No other nodes were identified at palpation, Skin examination revealed sharply delimited erythema, with marked hyperthermic induration in latero-proximal region of left upper arm, i.e. over the deltoid muscle mass, on an area of about 10 times 15 cm. A prophylactic antibiotic therapy with cefuroxime was started at 750 mg 3 times daily accompanied by topical corticosteroid application with DERMOXIN ointment and local disinfection with CHINOSOL compresses and local cooling. Rapid improvement was observed with this treatment. Laboratory tests done on 14 Nov 2010 revealed elevated C-reactive protein of 1.17 mg/dL accompanied by normal creatine phosphokinase (CK) and normal MB isoenzyme (CK-MB), and normal both liver and pancreas enzymes. Total leukocytes (WBC) count and total protein were at upper boundary but still in normal range. Protein electrophoresis showed elevated percentages in alpha1-globulin, alpha2-globulin, and beta-globulin fractions. Further, elevated glucose and elevated triglycerides were observed. All other parameters in blood showed normal results. Urine status revealed no abnormalities. Analysis by flow cytometry revealed slight elevations in erythrocytes, leukocytes, and epithelial cells. Bacteria count was within normal range and no pathological cylinders were detected. Patient's condition improved and she was discharged on 15 Nov 2010 in good subjective condition. The patient was directed to continue treatment with DERMOXIN ointment for a maximum of 10 further days and of oral Cefuroxime, 250 mg 2 times daily for further 5 days.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth, Laboratory test normal
Clinical narrative: Initial physician report received on 01 Dec 2010: This patient with unknown medical history was vaccinated with MENVEO in the left deltoid muscle on 09 Nov 2010. In the evening of 09 Nov 2010, the patient developed erythema with itching at injection site. On 10 Nov 2010, she noticed severe swelling in left upper arm with local feeling of both hyperthermia and tension. The above did not experience any deterioration of the general condition and fever was explicitly denied. Evidently on the same day, the patient presented at the hospital and was admitted. On admission, the patient was differentially diagnosed with vaccination reaction in left upper arm, and analysis of (potentially) beginning infection. The patient was in good general and nutritional condition. Gross clinical and gross neurological examination did not reveal any pathological findings, but the axillary nodes of left side were slightly enlarged. No other nodes were identified at palpation, Skin examination revealed sharply delimited erythema, with marked hyperthermic induration in latero-proximal region of left upper arm, i.e. over the deltoid muscle mass, on an area of about 10 times 15 cm. A prophylactic antibiotic therapy with cefuroxime was started at 750 mg 3 times daily accompanied by topical corticosteroid application with DERMOXIN ointment and local disinfection with CHINOSOL compresses and local cooling. Rapid improvement was observed with this treatment. Laboratory tests done on 14 Nov 2010 revealed elevated C-reactive protein of 1.17 mg/dL accompanied by normal creatine phosphokinase (CK) and normal MB isoenzyme (CK-MB), and normal both liver and pancreas enzymes. Total leukocytes (WBC) count and total protein were at upper boundary but still in normal range. Protein electrophoresis showed elevated percentages in alpha1-globulin, alpha2-globulin, and beta-globulin fractions. Further, elevated glucose and elevated triglycerides were observed. All other parameters in blood showed normal results. Urine status revealed no abnormalities. Analysis by flow cytometry revealed slight elevations in erythrocytes, leukocytes, and epithelial cells. Bacteria count was within normal range and no pathological cylinders were detected. Patient's condition improved and she was discharged on 15 Nov 2010 in good subjective condition. The patient was directed to continue treatment with DERMOXIN ointment for a maximum of 10 further days and of oral Cefuroxime, 250 mg 2 times daily for further 5 days.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Lymphadenopathy, Melanocytic naevus, Neurological examination normal, Pancreatic enzymes normal, Protein total normal
Clinical narrative: Initial physician report received on 01 Dec 2010: This patient with unknown medical history was vaccinated with MENVEO in the left deltoid muscle on 09 Nov 2010. In the evening of 09 Nov 2010, the patient developed erythema with itching at injection site. On 10 Nov 2010, she noticed severe swelling in left upper arm with local feeling of both hyperthermia and tension. The above did not experience any deterioration of the general condition and fever was explicitly denied. Evidently on the same day, the patient presented at the hospital and was admitted. On admission, the patient was differentially diagnosed with vaccination reaction in left upper arm, and analysis of (potentially) beginning infection. The patient was in good general and nutritional condition. Gross clinical and gross neurological examination did not reveal any pathological findings, but the axillary nodes of left side were slightly enlarged. No other nodes were identified at palpation, Skin examination revealed sharply delimited erythema, with marked hyperthermic induration in latero-proximal region of left upper arm, i.e. over the deltoid muscle mass, on an area of about 10 times 15 cm. A prophylactic antibiotic therapy with cefuroxime was started at 750 mg 3 times daily accompanied by topical corticosteroid application with DERMOXIN ointment and local disinfection with CHINOSOL compresses and local cooling. Rapid improvement was observed with this treatment. Laboratory tests done on 14 Nov 2010 revealed elevated C-reactive protein of 1.17 mg/dL accompanied by normal creatine phosphokinase (CK) and normal MB isoenzyme (CK-MB), and normal both liver and pancreas enzymes. Total leukocytes (WBC) count and total protein were at upper boundary but still in normal range. Protein electrophoresis showed elevated percentages in alpha1-globulin, alpha2-globulin, and beta-globulin fractions. Further, elevated glucose and elevated triglycerides were observed. All other parameters in blood showed normal results. Urine status revealed no abnormalities. Analysis by flow cytometry revealed slight elevations in erythrocytes, leukocytes, and epithelial cells. Bacteria count was within normal range and no pathological cylinders were detected. Patient's condition improved and she was discharged on 15 Nov 2010 in good subjective condition. The patient was directed to continue treatment with DERMOXIN ointment for a maximum of 10 further days and of oral Cefuroxime, 250 mg 2 times daily for further 5 days.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Red blood cell count increased, Skin test positive, Skin tightness, Urinary sediment present, Urine analysis normal
Clinical narrative: Initial physician report received on 01 Dec 2010: This patient with unknown medical history was vaccinated with MENVEO in the left deltoid muscle on 09 Nov 2010. In the evening of 09 Nov 2010, the patient developed erythema with itching at injection site. On 10 Nov 2010, she noticed severe swelling in left upper arm with local feeling of both hyperthermia and tension. The above did not experience any deterioration of the general condition and fever was explicitly denied. Evidently on the same day, the patient presented at the hospital and was admitted. On admission, the patient was differentially diagnosed with vaccination reaction in left upper arm, and analysis of (potentially) beginning infection. The patient was in good general and nutritional condition. Gross clinical and gross neurological examination did not reveal any pathological findings, but the axillary nodes of left side were slightly enlarged. No other nodes were identified at palpation, Skin examination revealed sharply delimited erythema, with marked hyperthermic induration in latero-proximal region of left upper arm, i.e. over the deltoid muscle mass, on an area of about 10 times 15 cm. A prophylactic antibiotic therapy with cefuroxime was started at 750 mg 3 times daily accompanied by topical corticosteroid application with DERMOXIN ointment and local disinfection with CHINOSOL compresses and local cooling. Rapid improvement was observed with this treatment. Laboratory tests done on 14 Nov 2010 revealed elevated C-reactive protein of 1.17 mg/dL accompanied by normal creatine phosphokinase (CK) and normal MB isoenzyme (CK-MB), and normal both liver and pancreas enzymes. Total leukocytes (WBC) count and total protein were at upper boundary but still in normal range. Protein electrophoresis showed elevated percentages in alpha1-globulin, alpha2-globulin, and beta-globulin fractions. Further, elevated glucose and elevated triglycerides were observed. All other parameters in blood showed normal results. Urine status revealed no abnormalities. Analysis by flow cytometry revealed slight elevations in erythrocytes, leukocytes, and epithelial cells. Bacteria count was within normal range and no pathological cylinders were detected. Patient's condition improved and she was discharged on 15 Nov 2010 in good subjective condition. The patient was directed to continue treatment with DERMOXIN ointment for a maximum of 10 further days and of oral Cefuroxime, 250 mg 2 times daily for further 5 days.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Vaccination site reaction, White blood cell count increased
Clinical narrative: Initial physician report received on 01 Dec 2010: This patient with unknown medical history was vaccinated with MENVEO in the left deltoid muscle on 09 Nov 2010. In the evening of 09 Nov 2010, the patient developed erythema with itching at injection site. On 10 Nov 2010, she noticed severe swelling in left upper arm with local feeling of both hyperthermia and tension. The above did not experience any deterioration of the general condition and fever was explicitly denied. Evidently on the same day, the patient presented at the hospital and was admitted. On admission, the patient was differentially diagnosed with vaccination reaction in left upper arm, and analysis of (potentially) beginning infection. The patient was in good general and nutritional condition. Gross clinical and gross neurological examination did not reveal any pathological findings, but the axillary nodes of left side were slightly enlarged. No other nodes were identified at palpation, Skin examination revealed sharply delimited erythema, with marked hyperthermic induration in latero-proximal region of left upper arm, i.e. over the deltoid muscle mass, on an area of about 10 times 15 cm. A prophylactic antibiotic therapy with cefuroxime was started at 750 mg 3 times daily accompanied by topical corticosteroid application with DERMOXIN ointment and local disinfection with CHINOSOL compresses and local cooling. Rapid improvement was observed with this treatment. Laboratory tests done on 14 Nov 2010 revealed elevated C-reactive protein of 1.17 mg/dL accompanied by normal creatine phosphokinase (CK) and normal MB isoenzyme (CK-MB), and normal both liver and pancreas enzymes. Total leukocytes (WBC) count and total protein were at upper boundary but still in normal range. Protein electrophoresis showed elevated percentages in alpha1-globulin, alpha2-globulin, and beta-globulin fractions. Further, elevated glucose and elevated triglycerides were observed. All other parameters in blood showed normal results. Urine status revealed no abnormalities. Analysis by flow cytometry revealed slight elevations in erythrocytes, leukocytes, and epithelial cells. Bacteria count was within normal range and no pathological cylinders were detected. Patient's condition improved and she was discharged on 15 Nov 2010 in good subjective condition. The patient was directed to continue treatment with DERMOXIN ointment for a maximum of 10 further days and of oral Cefuroxime, 250 mg 2 times daily for further 5 days.
Age: 43.0
Sex: M
Vaccine: FLU3, HEPA, MMR, MNQ, TDAP, VARCEL
Symptoms: Dyspnoea, Electrocardiogram normal, Eye pruritus, Full blood count normal, Lacrimation increased
Clinical narrative: On 12/3/10 pt received vaccines at approximately 10AM and left clinic at 10:30. He states thru translator that at 1:30 he took 2 TYLENOL for arm soreness. At 1:40 he began to have itchy & teary eyes. At 2:30 he felt as if his throat was swelling and had shortness of breath. He went to ER and was given meds.
Age: 43.0
Sex: M
Vaccine: FLU3, HEPA, MMR, MNQ, TDAP, VARCEL
Symptoms: Metabolic function test, Pain in extremity, Pharyngeal oedema
Clinical narrative: On 12/3/10 pt received vaccines at approximately 10AM and left clinic at 10:30. He states thru translator that at 1:30 he took 2 TYLENOL for arm soreness. At 1:40 he began to have itchy & teary eyes. At 2:30 he felt as if his throat was swelling and had shortness of breath. He went to ER and was given meds.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, TD
Symptoms: Contusion, Erythema, Myalgia, Nausea, Pruritus
Clinical narrative: Myalgias x 3 days - nausea x 3 days - local, skin rx w/erythema, bruising, itching 20x15cm started 4 days later.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, TD
Symptoms: Skin reaction
Clinical narrative: Myalgias x 3 days - nausea x 3 days - local, skin rx w/erythema, bruising, itching 20x15cm started 4 days later.
Age: 3.0
Sex: F
Vaccine: FLUN3, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Expanding swelling/redness (R) thigh after immunization given on 12/10/10 without fever. Pt given ANCEF shot & put on KEFLEX today (12/13/10).
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: CSF protein increased, Computerised tomogram normal, Dysphagia, Dyspnoea, Electromyogram abnormal
Clinical narrative: Symptoms started 10/24 - numbness/tingling of fingers and toes. 10/25 generalized numbness and difficulty walking -> went to ED. ED BP 200/100. Neuro ->10/27 diffuse reduction in reflex on lower extremities. SOB and difficulty swallowing tx: cycle of plasmapheresis and IVIG therapy. Transferred to rehab on 11/15.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Epstein-Barr virus antibody positive, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Hyporeflexia
Clinical narrative: Symptoms started 10/24 - numbness/tingling of fingers and toes. 10/25 generalized numbness and difficulty walking -> went to ED. ED BP 200/100. Neuro ->10/27 diffuse reduction in reflex on lower extremities. SOB and difficulty swallowing tx: cycle of plasmapheresis and IVIG therapy. Transferred to rehab on 11/15.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Neurological examination abnormal, Nuclear magnetic resonance imaging normal, Paraesthesia, Plasmapheresis
Clinical narrative: Symptoms started 10/24 - numbness/tingling of fingers and toes. 10/25 generalized numbness and difficulty walking -> went to ED. ED BP 200/100. Neuro ->10/27 diffuse reduction in reflex on lower extremities. SOB and difficulty swallowing tx: cycle of plasmapheresis and IVIG therapy. Transferred to rehab on 11/15.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Scan brain
Clinical narrative: Symptoms started 10/24 - numbness/tingling of fingers and toes. 10/25 generalized numbness and difficulty walking -> went to ED. ED BP 200/100. Neuro ->10/27 diffuse reduction in reflex on lower extremities. SOB and difficulty swallowing tx: cycle of plasmapheresis and IVIG therapy. Transferred to rehab on 11/15.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Cyanosis, Grunting, Musculoskeletal stiffness
Clinical narrative: Grunting, generalized body stiffness, hand/feet blue lasting 1 minute.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Adverse reaction at injection site - redness, swelling, itching -> noticed for the 1st time approximately 48 hrs after vaccination, currently using BENADRYL. Spoke again after a few days - better, still red & itchy.
Age: 17.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Burning sensation, Dizziness, Injection site pain
Clinical narrative: Possible seizure, burning sensation at site, dizziness.
Age: 71.0
Sex: U
Vaccine: TDAP
Symptoms: Induration, Papule, Rash pruritic
Clinical narrative: Rash. Small indurated, very pruritic papules on abdo, onset within 2 hrs of vaccine antihistamine, topical steroid.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Within 24 hours of receiving vaccine pt developed redness & swelling at site of injection 72 hrs later site 4x4 cm center firm red surrounded by 15cm x 8cm erythema.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Presents with inner aspect (L) upper arm fiery red, non-tender, not indurated. No nodes felt (L) axillary. Cellulitis, aseptic. No Rx.
Age: 66.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Wrong drug administered
Clinical narrative: Pt. was given Hep B instead of TWINRIX. We gave pt. Hep A (ped) dose per pharmacist at Glaxo Smith Kline.
Age: 0.6
Sex: F
Vaccine: RV1
Symptoms: Tongue discolouration
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of black tongue in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced black tongue. It was reported that the subject ate mango in the morning and later received a dose of ROTARIX. After receiving ROTARIX, the subject's tongue turned black. The nurse was able to wipe the back substance off the subject's tongue. At the time of reporting the outcome of the black tongue was unspecified. Follow-up information was received via a nurse at the subject's physician's office on 23 November 2010. It was reported that the subject was a 7 month old female. The event of black tongue occurred on 05 November 2010 and resolved the same day. It was not considered to be serious. It was suggested that the event could have been associated with a reaction to mangos, but no further detail concerning this was provided. The dose of ROTARIX was reported to be the subject's 3rd dose and concurrent medications included PEDIARIX (GlaxoSmithKline, 21 May 2010), PREVNAR- 13 (unknown manufacturer, 08 June 2010) and unspecified dose flu vaccine all given intramuscularly (05 November 2010).
Age: 12.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Ataxia, Bladder catheterisation, Convulsion, Inflammation, Influenza virus test
Clinical narrative: Client received flu shot 9/15/10 and had no reaction until 10/15/10. He woke up and could not urinate. Had pain and was taken to doctor. Was cathed for 940cc of urine. Was not able to urinate and may have had a seizure later that day and 911 was called and went to hospital. Was in ICU for 1 week. Diagnosed with transverse myelitis. Mother stated her mother-in-law had GBS but he has had flu shots every year with no problems. Drs traced symptoms back to flu shot.
Age: 12.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Influenza virus test positive, Mental status changes, Nervous system disorder, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal cord abnormal
Clinical narrative: Client received flu shot 9/15/10 and had no reaction until 10/15/10. He woke up and could not urinate. Had pain and was taken to doctor. Was cathed for 940cc of urine. Was not able to urinate and may have had a seizure later that day and 911 was called and went to hospital. Was in ICU for 1 week. Diagnosed with transverse myelitis. Mother stated her mother-in-law had GBS but he has had flu shots every year with no problems. Drs traced symptoms back to flu shot.
Age: 12.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Urinary retention, West Nile virus test negative
Clinical narrative: Client received flu shot 9/15/10 and had no reaction until 10/15/10. He woke up and could not urinate. Had pain and was taken to doctor. Was cathed for 940cc of urine. Was not able to urinate and may have had a seizure later that day and 911 was called and went to hospital. Was in ICU for 1 week. Diagnosed with transverse myelitis. Mother stated her mother-in-law had GBS but he has had flu shots every year with no problems. Drs traced symptoms back to flu shot.
Age: 12.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Catheter placement, Computerised tomogram, Convulsion, Intensive care, Myelitis transverse
Clinical narrative: Client received flu shot 9/15/10 and had no reaction until 10/15/10. He woke up and could not urinate. Had pain and was taken to doctor. Was cathed for 940cc of urine. Was not able to urinate and may have had a seizure later that day and 911 was called and went to hospital. Was in ICU for 1 week. Diagnosed with transverse myelitis. Mother stated her mother-in-law had GBS but he has had flu shots every year with no problems. Drs traced symptoms back to flu shot.
Age: 12.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain, Urinary retention
Clinical narrative: Client received flu shot 9/15/10 and had no reaction until 10/15/10. He woke up and could not urinate. Had pain and was taken to doctor. Was cathed for 940cc of urine. Was not able to urinate and may have had a seizure later that day and 911 was called and went to hospital. Was in ICU for 1 week. Diagnosed with transverse myelitis. Mother stated her mother-in-law had GBS but he has had flu shots every year with no problems. Drs traced symptoms back to flu shot.
Age: 14.0
Sex: M
Vaccine: HPV4, FLUX, HPV4
Symptoms: Encephalitis, Headache, Lethargy, Mental status changes
Clinical narrative: Information has been received from a physician concerning a 14 year old male patient with attention deficit hyperactivity disorder (ADHD) and no known drug allergies who on 09-SEP-2010, was vaccinated IM with 0.5 ml first dose of GARDASIL (Lot # 666162/0565Z). Concomitant therapy included FLUMIST and METADATE. On 25-NOV-2010, the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (Lot # 663559/1178Y). The physician reported that on 25-NOV-2010, the patient experienced frontal headache, lethargy, altered mental state, chills, and abdominal pain. Multiple diagnostic tests were performed: complete blood cell count, liver function test (results were not provided) and the Epstein-Barr virus (EBV) specific -IgG level was 4.86. The patient was referred to a neurologist. It was also reported that the patient developed Guillain-Barre Syndrome while on therapy with GARDASIL and was hospitalized, but then it was reported that the initial diagnosis was immunization encephalitis (the office manager could not confirm that diagnosis of Guillain Barre Syndrome or the hospitalization). The office manager stated that she was not aware of any serious criteria and was awaiting follow-up from the hospital. She also stated that she would call the hospital to get contact information and to expedite the neurologist consult findings and results of other testing. The office contacted during telephone follow-up could not supply the following information: neurologist name and contact information. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, FLUX, HPV4
Symptoms: Abdominal pain, Chills, Encephalitis post immunisation, Epstein-Barr virus antibody positive, Full blood count
Clinical narrative: Information has been received from a physician concerning a 14 year old male patient with attention deficit hyperactivity disorder (ADHD) and no known drug allergies who on 09-SEP-2010, was vaccinated IM with 0.5 ml first dose of GARDASIL (Lot # 666162/0565Z). Concomitant therapy included FLUMIST and METADATE. On 25-NOV-2010, the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (Lot # 663559/1178Y). The physician reported that on 25-NOV-2010, the patient experienced frontal headache, lethargy, altered mental state, chills, and abdominal pain. Multiple diagnostic tests were performed: complete blood cell count, liver function test (results were not provided) and the Epstein-Barr virus (EBV) specific -IgG level was 4.86. The patient was referred to a neurologist. It was also reported that the patient developed Guillain-Barre Syndrome while on therapy with GARDASIL and was hospitalized, but then it was reported that the initial diagnosis was immunization encephalitis (the office manager could not confirm that diagnosis of Guillain Barre Syndrome or the hospitalization). The office manager stated that she was not aware of any serious criteria and was awaiting follow-up from the hospital. She also stated that she would call the hospital to get contact information and to expedite the neurologist consult findings and results of other testing. The office contacted during telephone follow-up could not supply the following information: neurologist name and contact information. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, FLUX, HPV4
Symptoms: Guillain-Barre syndrome, Headache, Lethargy, Liver function test, Mental disorder
Clinical narrative: Information has been received from a physician concerning a 14 year old male patient with attention deficit hyperactivity disorder (ADHD) and no known drug allergies who on 09-SEP-2010, was vaccinated IM with 0.5 ml first dose of GARDASIL (Lot # 666162/0565Z). Concomitant therapy included FLUMIST and METADATE. On 25-NOV-2010, the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (Lot # 663559/1178Y). The physician reported that on 25-NOV-2010, the patient experienced frontal headache, lethargy, altered mental state, chills, and abdominal pain. Multiple diagnostic tests were performed: complete blood cell count, liver function test (results were not provided) and the Epstein-Barr virus (EBV) specific -IgG level was 4.86. The patient was referred to a neurologist. It was also reported that the patient developed Guillain-Barre Syndrome while on therapy with GARDASIL and was hospitalized, but then it was reported that the initial diagnosis was immunization encephalitis (the office manager could not confirm that diagnosis of Guillain Barre Syndrome or the hospitalization). The office manager stated that she was not aware of any serious criteria and was awaiting follow-up from the hospital. She also stated that she would call the hospital to get contact information and to expedite the neurologist consult findings and results of other testing. The office contacted during telephone follow-up could not supply the following information: neurologist name and contact information. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Chills, Diarrhoea, Nausea, Vomiting
Clinical narrative: Chills, nausea, headache, vomiting, diarrhea; on 12/4/10 developed skin rash.
Age: 46.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Chills, Diarrhoea, Headache, Nausea, Rash
Clinical narrative: Chills, nausea, headache, vomiting, diarrhea; on 12/4/10 developed skin rash.
Age: 46.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Vomiting
Clinical narrative: Chills, nausea, headache, vomiting, diarrhea; on 12/4/10 developed skin rash.
Age: 2.7
Sex: F
Vaccine: FLUN3, PNC13, FLUN3, PNC13
Symptoms: Contusion, Pain, Pruritus, Skin discolouration, Skin warm
Clinical narrative: This is an initial spontaneous report from a contactable reporter on behalf of a physician. This 2years 10 months old female patient received PREVNAR 13 on 15NOV2010 at a dose of 0.5 ml for an unknown indication. The relevant medical history of the patient was unknown. The concomitant medications of the consumer included FLUMIST intranasal on 15NOV2010 at an unknown dose, frequency, indication. The reporter mentioned that the patient suffered adverse reactions like bruises, itching, swelling, hard to touch, pain, on 15NOV2010 while being on PREVNAR 13. The reporter mentioned that bruises had decrease from 21NOV2010 to 28NOV2010 but the swelling was still persistent. The relevant laboratory tests were unknown. The last action taken as a result of the event was unknown. The therapeutic measures taken as a result of the event were TYLENOL and ice for 4 days. At the time of the report, the patient did not recover from the event.
Age: 2.7
Sex: F
Vaccine: FLUN3, PNC13, FLUN3, PNC13
Symptoms: Swelling, Tenderness
Clinical narrative: This is an initial spontaneous report from a contactable reporter on behalf of a physician. This 2years 10 months old female patient received PREVNAR 13 on 15NOV2010 at a dose of 0.5 ml for an unknown indication. The relevant medical history of the patient was unknown. The concomitant medications of the consumer included FLUMIST intranasal on 15NOV2010 at an unknown dose, frequency, indication. The reporter mentioned that the patient suffered adverse reactions like bruises, itching, swelling, hard to touch, pain, on 15NOV2010 while being on PREVNAR 13. The reporter mentioned that bruises had decrease from 21NOV2010 to 28NOV2010 but the swelling was still persistent. The relevant laboratory tests were unknown. The last action taken as a result of the event was unknown. The therapeutic measures taken as a result of the event were TYLENOL and ice for 4 days. At the time of the report, the patient did not recover from the event.
Age: 2.7
Sex: F
Vaccine: FLUN3, PNC13, FLUN3, PNC13
Symptoms: Contusion, Induration, Pain, Pruritus, Swelling
Clinical narrative: This is an initial spontaneous report from a contactable reporter on behalf of a physician. This 2years 10 months old female patient received PREVNAR 13 on 15NOV2010 at a dose of 0.5 ml for an unknown indication. The relevant medical history of the patient was unknown. The concomitant medications of the consumer included FLUMIST intranasal on 15NOV2010 at an unknown dose, frequency, indication. The reporter mentioned that the patient suffered adverse reactions like bruises, itching, swelling, hard to touch, pain, on 15NOV2010 while being on PREVNAR 13. The reporter mentioned that bruises had decrease from 21NOV2010 to 28NOV2010 but the swelling was still persistent. The relevant laboratory tests were unknown. The last action taken as a result of the event was unknown. The therapeutic measures taken as a result of the event were TYLENOL and ice for 4 days. At the time of the report, the patient did not recover from the event.
Age: 47.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Runny nose, congestion, body ache, fatigue, all moderate in severity.
Age: 43.0
Sex: M
Vaccine: FLUN3
Symptoms: Fatigue, Feeling abnormal, Headache, Migraine, Oropharyngeal pain
Clinical narrative: Felt awful - sneezing, headache, runny nose, tired, all moderate in severity. Sore throat started 12/10 (severe). Symptoms lasted until 12/13. Took Excedrin, Sudafed.  Also had migraine 12/13 - took Maxalt.
Age: 43.0
Sex: M
Vaccine: FLUN3
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Felt awful - sneezing, headache, runny nose, tired, all moderate in severity. Sore throat started 12/10 (severe). Symptoms lasted until 12/13. Took Excedrin, Sudafed.  Also had migraine 12/13 - took Maxalt.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Diplopia, Headache
Clinical narrative: 22 y/o male AD, Specialist, is referred to medical center from Allergy for c/o diplopia after Rabies vaccine dose # 1. Received Flu vaccine some 25 days prior to the Rabies vaccine. Receiving rabies vaccine due to dog bite prophylaxis.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram thorax abnormal, Cough, Deep vein thrombosis, Headache, Malaise
Clinical narrative: Became ill 11/9/10 fever, h/a, cough on 11/16/10 large left positive deep vein thrombosis and bilateral pulmonary emboli dx.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Pulmonary embolism, Pyrexia, Ultrasound Doppler abnormal
Clinical narrative: Became ill 11/9/10 fever, h/a, cough on 11/16/10 large left positive deep vein thrombosis and bilateral pulmonary emboli dx.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchiolitis, Cough, Pneumonia viral, Pyrexia, Vomiting
Clinical narrative: Fever, coughing (lead to bronchiolitis), vomiting, viral pneumonia (+). Azithromycin - 5 day treatment Albuterol syrup - 5 days treatment.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Injection site cellulitis, Injection site induration
Clinical narrative: Developed a 2.5cm x 2.5cm area of induration/cellulitis adjacent to injection site. Improved with ROCEPHIN & course of OMNICEF. Injection site, area of induration (L) thigh.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Pain, Skin warm
Clinical narrative: Pt. called and stated had temp up to 103 degrees F, on/off for 3 days, body aches. Also stated arm, where got vaccine, was red & warm to touch 24h after vaccine.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Patient received Flu Vaccination on 12/4/10 at approximately 2:16PM. At approximately 3:45PM, patient called and said she was experiencing pain radiating thru arm (down to fingers and in neck). I recommended patient seek immediate medical attention. On follow up with patient, she called us back on 12/7/10 and said the pain dissipated over the last couple days and she feels better now. Patient said she did not seek medical attention.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Pyrexia, Rash macular
Clinical narrative: High fever and chills 2 days in bed splotches on arm (left).
Age: 10.0
Sex: M
Vaccine: FLUN3, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: 12/9/10 - Started having redness & swelling at injection site today - cellulitis - started on KEFLEX per Dr.
Age: 52.0
Sex: U
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Malaise, Muscular weakness, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Sick & weak in left arm, have seen a doctor & orthopedic, MRI & X-rays still unable to use my left arm in some positions.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Expired drug administered, No adverse event
Clinical narrative: None reported. Administered out of date vaccine - spoke with pt mom, no report of any SE or problems.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Upon injection he felt a dull aching pain, had muscle soreness for 1 day. By day 2 turned into a "debilitating" pain and could not lift arm above shoulder without intense pain at injection site. Pain radiated down arm. Also reaching across body caused intense pain. Saw MD on Nov 26 diagnosed with "Impingement Syndrome" bursitis. Has nearly complete relief now following injection of cortisone into bursa.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Rotator cuff syndrome, Ultrasound joint, X-ray
Clinical narrative: Upon injection he felt a dull aching pain, had muscle soreness for 1 day. By day 2 turned into a "debilitating" pain and could not lift arm above shoulder without intense pain at injection site. Pain radiated down arm. Also reaching across body caused intense pain. Saw MD on Nov 26 diagnosed with "Impingement Syndrome" bursitis. Has nearly complete relief now following injection of cortisone into bursa.
Age: 37.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Induration, Local swelling, Pain
Clinical narrative: Localized redness & swelling/induration and pain.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Skin reaction
Clinical narrative: Flu shot 10/12/10 seen at MD office 10/28/10 - treated for skin reaction poss due to injection. Treated w/ KEFLEX 500mg twice daily x 7d & Antibiotic ointment. Documented in chart but not reported by PA seeing pt.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Dehydration, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, moderated dehydr seen in office 12/2/10 tx with ZOFRAN, oral rehydration, improved by 12/3/10.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Pain
Clinical narrative: Increase in pain and general loss of energy - pain constant and did not respond to regular pain reducers; used pain meds, pain patches, ice packs and no relief. Episode lasted over 30 days.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Local swelling, Oedema mouth, Oedema peripheral, Pharyngeal oedema
Clinical narrative: Throat and mouth swelling severe rash over entire body swelling of feet, hands, face, neck, trouble breathing.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Swelling face
Clinical narrative: Throat and mouth swelling severe rash over entire body swelling of feet, hands, face, neck, trouble breathing.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Impaired driving ability, Injected limb mobility decreased, Injection site induration, Pain
Clinical narrative: After receiving the shot (PNEUMOVAX), pt said that her shoulder joint/upper deltoid area became very hard to the touch. She could not move her arm up & down the next day. As a result, she could not drive to see her PCP. Pt saw a nurse practitioner and was told that it may be tendonitis. On the 4th day, she had another appt. with nurse practitioner. The TENS units helped her a lot to relieve the pain.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt reported redness, soreness at site of injection & swelling from injection site almost to elbow (L) delt - injection site of PNEUMOVAX soreness later that night, swelling next morning.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient called pharmacy manager at aforementioned location stating that she had been having problems of severe pain in the Left arm near injection site, which continued for 2 weeks. She stated no fever and was unable to pinpoint exact date of onset. The patient called her private prescriber who issued a prescription for Tramadol 50mg. One tablet by mouth every 6 hours pm pain, #20 with 1 refill. Patient reported having no redness or swelling at the injection site and she was feeling much better at time of our discussion.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Erythema, warmth of skin over deltoid, some firmness & tenderness of the deltoid.
Age: 19.0
Sex: M
Vaccine: FLU3, HPV4, TDAP
Symptoms: Abdominal pain upper, Body temperature increased, Insomnia
Clinical narrative: Temp 102.2 difficulty sleeping stomach ache.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Pruritus, Throat tightness
Clinical narrative: Pt reported that her "throat felt like it was closing up and diffuse itching (no rash)" within 15 min of receiving flu & HPV vaccine - but only reported these symptoms upon 2nd visit 12/3/10. Pt stated she was "not concerned" on 10/4 so did not report sx which resolved spontaneously.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Mass, Pain, Skin warm
Clinical narrative: Received vaccines 11/29/10 reaction started 11/30/10 red raised 3 inch lump sore warm to touch.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Gastrointestinal disorder, Nausea, Vertigo
Clinical narrative: Shortly after vaccination pt developed vertigo lasting the rest of the day and GI symptoms (nausea (without vomiting) diarrhea) lasting 3 days. Cleared up on own with no treatment necessary.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: C/o bilateral ringing in ears for at least a wk after receiving the flu vaccine no treatment at time of notification.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site rash, Rash, Rash papular
Clinical narrative: R thigh site of injection papular rash 12/3/10 started 12/1/10 also with different rash face/chest/neck - contact derm.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Erythema, Injection site pruritus, Injection site reaction, Paraesthesia
Clinical narrative: Day after injections patient described itching and tingling at injection site. Red and warm to touch. Dx. cellulitis-treated with KEFLEX 500 tid.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Skin warm
Clinical narrative: Day after injections patient described itching and tingling at injection site. Red and warm to touch. Dx. cellulitis-treated with KEFLEX 500 tid.
Age: 1.23
Sex: F
Vaccine: HEP
Symptoms: Familial risk factor, Gianotti-Crosti syndrome, Rash, Roseola
Clinical narrative: Developed Roseola 3 days post vaccination. Infection cleared. About 2 wks later developed new and different rash. Diagnosed by PCP with Gianotti Crosti Syndrome. This child's cousin dx'd w/same condition following Hep. B vaccine. Reportedly the cousin was vaccinated in another county.
Age: 1.26
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Local reaction, red indurations 10 days after immunizations.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR
Symptoms: Diet refusal, Insomnia, Irritability, Lethargy, Pyrexia
Clinical narrative: 1800 - very lethargic but fussy, fever 101, refusing food and drink. Hard to sleep. Lasted about 2 1/2 days. Controlled with TYLENOL.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Varicella virus test positive
Clinical narrative: ZOSTAVAX administered 2-25-08. Patient presented with dermatomal rash on 11-30-10. Culture proved this was due to Varicella Zoster Virus.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: Large local inflammatory reaction on left upper extremity, warm to touch, pink color, pruritic.
Age: 17.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Asthenia, Dizziness, Laboratory test normal, Pallor, Vomiting
Clinical narrative: Patient had dizziness and had vomiting - (next day) was pale - weak - same day of vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Extended time of redness at injection area. After 6 days area still red and slight pain at the touch injection site redness/pain had not resolved.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMR, VARCEL
Symptoms: Erythema, Skin lesion
Clinical narrative: Red raised lesions covering the trunk & neck.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: SWELLING, ITCHING, SORE/ TENDERNESS, FEVER, LARGE KNOT AT THE SITE OF VACCINATION,
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Tenderness
Clinical narrative: SWELLING, ITCHING, SORE/ TENDERNESS, FEVER, LARGE KNOT AT THE SITE OF VACCINATION,
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal behaviour, Aggression, Irritability
Clinical narrative: Patient started having behavioral changes. Patient was more irritable and violent and difficult to control.  Since that time, she has good days and bad days.  Her mother definitely noticed a change in her behavior after receiving her influenza booster.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Histamine Release Reaction, swelling, red welt L deltoid area, treated with Zyrtec for 3 days and cold compresses
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Decreased appetite, Irritability
Clinical narrative: Fussy, lack of appetite, taken to ER by parents
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Parents noted large area of redness and swelling around the site of injection on Left lateral thigh. They called. I advised that they bring the patient in.  They did, the next morning.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Noticed his breathing was worse a few days later, and he feels as though his breathing's been worse ever since the vaccine was administered.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Allergy to vaccine, Body temperature increased, Rash
Clinical narrative: Mom reports child broke out in a rash on face and chest within a few hours and ran a temp. of 102.9 axillary.  Mom took child to Hosp. ER. ER Doctor told Mom it was probably a rxn to the flu shot and child may have an egg allergy.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Client reports that she had mild soreness at site of administration the same night as administration. 27 hours after administration client reports that she had severe swelling and redness at site of administration(Rt. Deltoid) with redness, swelling and stiffness of entire extremity (Rt. Arm). ER Report assessment documents a 5 cm. induration in Right middle deltoid. ER treatment included 60 mg of Toradol IM and ice pack to site.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: Client reports that she had mild soreness at site of administration the same night as administration. 27 hours after administration client reports that she had severe swelling and redness at site of administration(Rt. Deltoid) with redness, swelling and stiffness of entire extremity (Rt. Arm). ER Report assessment documents a 5 cm. induration in Right middle deltoid. ER treatment included 60 mg of Toradol IM and ice pack to site.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Activities of daily living impaired, Delirium, Dizziness, Fatigue
Clinical narrative: Severe nausea, severe body aches, delirium and dizziness, severe stomach pain, interrupted sleep and tiredness and severe fatigue.  All the above named adverse events resulted in the interference of normal activities and in retrospect, I should have sought medical help to ease the severe nausea which prevented me from performing normal tasks and sleeping.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Sleep disorder
Clinical narrative: Severe nausea, severe body aches, delirium and dizziness, severe stomach pain, interrupted sleep and tiredness and severe fatigue.  All the above named adverse events resulted in the interference of normal activities and in retrospect, I should have sought medical help to ease the severe nausea which prevented me from performing normal tasks and sleeping.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Hypersensitivity, Influenza virus test
Clinical narrative: Swelling of the forearm, forehead, lip. Patient arrived at Hospital and received an injection of ephenephrine and other drugs for allergic reactions.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Lip swelling, Oedema peripheral, Swelling face
Clinical narrative: Swelling of the forearm, forehead, lip. Patient arrived at Hospital and received an injection of ephenephrine and other drugs for allergic reactions.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Pruritus, Rash, Rash erythematous, Swelling face
Clinical narrative: 12/02/10 - Red facial rash, facial swelling, facial itching. 12/03/10 seen by CFNP Rx - MEDROL dose pack, ZYRTEC or BENADRYL as directed. BENADRYL 25mg given in office.