chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, HIV test negative, Headache, Hemiplegia, Influenza like illness
Clinical narrative: Pt is a 49 y/o male who presented to facility for his yearly flu shot on 11/16/2012. He had received a flu shot in the previous year without incident. He presented to his PCP on 1/18/2013 with a chief complaint of visual field deficits and headache for the past 5 days. His PCP referred him to an emergent visit with the ophthalmology department. He was referred from there to the emergency department with concern for a neurological process versus an ophthalmologic one. In the ED he was extensively worked up for neurological processes and found to be negative for HIV, CMV, meningitis, MS and at this time was not experiencing nausea, vomiting, or gait disturbances. He also received a gadolinium-enhanced MRI at this time. The MRI revealed a hypodense lesion in posterior limb of the right internal capsule surrounded by slight edema, suspicious for glioma or possible cerebrovascular accident. He was admitted to the hospital for further management on 1/18 and was continually followed by neurology through to his discharge on 2/6. After further investigation it was also discovered that he had recently had symptoms consistent with an upper respiratory viral illness prior to the onset of his neurologic symptoms. The timeline of this illness is unclear per the notes but is described as "flu-like symptoms" and were present before the onset of his neurological symtoms. During his hospitalization he experienced progressive loss of his visual field as well as neurologic decompensation presenting as left-sided hemiplegia and facial droop as well as gait disturbance. On 1/25 the lesion was biopsied and he was started on dexamethasone. This biopsy revealed a demyelinating process and neurology determined that this was likely a tumefactive demyelinating lesion, more specifically acute disseminated encephalomyelitis (ADEM). This is an exceptionally rare side effect of vaccinations but it has been reported in the literature and has been associated with previous influenza vaccinations. Given the timeline of onset after administration of the vaccine, it is difficult to determine whether the vaccine or the possible viral illness was the cause of the ADEM. In correspondence between doctors it was stated that this could be related to the influenza vaccine given in November. Based on an assessment with the Naranjo scale this would be classified as a possible adverse event associated with the administration of the influenza vaccine. Pt was initially treated with dexamethasone but was switched over to a 5 day course of intravenous methylprednisolone after diagnosis of a demyelinating disorder. This was followed up with prednisone taper and aggressive physical therapy. He continues to improve per the notes and has progressed to being able to walk with a cane.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Neurological decompensation, Neurological symptom, Nuclear magnetic resonance imaging abnormal, VIIth nerve paralysis, Viral test negative
Clinical narrative: Pt is a 49 y/o male who presented to facility for his yearly flu shot on 11/16/2012. He had received a flu shot in the previous year without incident. He presented to his PCP on 1/18/2013 with a chief complaint of visual field deficits and headache for the past 5 days. His PCP referred him to an emergent visit with the ophthalmology department. He was referred from there to the emergency department with concern for a neurological process versus an ophthalmologic one. In the ED he was extensively worked up for neurological processes and found to be negative for HIV, CMV, meningitis, MS and at this time was not experiencing nausea, vomiting, or gait disturbances. He also received a gadolinium-enhanced MRI at this time. The MRI revealed a hypodense lesion in posterior limb of the right internal capsule surrounded by slight edema, suspicious for glioma or possible cerebrovascular accident. He was admitted to the hospital for further management on 1/18 and was continually followed by neurology through to his discharge on 2/6. After further investigation it was also discovered that he had recently had symptoms consistent with an upper respiratory viral illness prior to the onset of his neurologic symptoms. The timeline of this illness is unclear per the notes but is described as "flu-like symptoms" and were present before the onset of his neurological symtoms. During his hospitalization he experienced progressive loss of his visual field as well as neurologic decompensation presenting as left-sided hemiplegia and facial droop as well as gait disturbance. On 1/25 the lesion was biopsied and he was started on dexamethasone. This biopsy revealed a demyelinating process and neurology determined that this was likely a tumefactive demyelinating lesion, more specifically acute disseminated encephalomyelitis (ADEM). This is an exceptionally rare side effect of vaccinations but it has been reported in the literature and has been associated with previous influenza vaccinations. Given the timeline of onset after administration of the vaccine, it is difficult to determine whether the vaccine or the possible viral illness was the cause of the ADEM. In correspondence between doctors it was stated that this could be related to the influenza vaccine given in November. Based on an assessment with the Naranjo scale this would be classified as a possible adverse event associated with the administration of the influenza vaccine. Pt was initially treated with dexamethasone but was switched over to a 5 day course of intravenous methylprednisolone after diagnosis of a demyelinating disorder. This was followed up with prednisone taper and aggressive physical therapy. He continues to improve per the notes and has progressed to being able to walk with a cane.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Viral upper respiratory tract infection, Visual field defect, Walking aid user
Clinical narrative: Pt is a 49 y/o male who presented to facility for his yearly flu shot on 11/16/2012. He had received a flu shot in the previous year without incident. He presented to his PCP on 1/18/2013 with a chief complaint of visual field deficits and headache for the past 5 days. His PCP referred him to an emergent visit with the ophthalmology department. He was referred from there to the emergency department with concern for a neurological process versus an ophthalmologic one. In the ED he was extensively worked up for neurological processes and found to be negative for HIV, CMV, meningitis, MS and at this time was not experiencing nausea, vomiting, or gait disturbances. He also received a gadolinium-enhanced MRI at this time. The MRI revealed a hypodense lesion in posterior limb of the right internal capsule surrounded by slight edema, suspicious for glioma or possible cerebrovascular accident. He was admitted to the hospital for further management on 1/18 and was continually followed by neurology through to his discharge on 2/6. After further investigation it was also discovered that he had recently had symptoms consistent with an upper respiratory viral illness prior to the onset of his neurologic symptoms. The timeline of this illness is unclear per the notes but is described as "flu-like symptoms" and were present before the onset of his neurological symtoms. During his hospitalization he experienced progressive loss of his visual field as well as neurologic decompensation presenting as left-sided hemiplegia and facial droop as well as gait disturbance. On 1/25 the lesion was biopsied and he was started on dexamethasone. This biopsy revealed a demyelinating process and neurology determined that this was likely a tumefactive demyelinating lesion, more specifically acute disseminated encephalomyelitis (ADEM). This is an exceptionally rare side effect of vaccinations but it has been reported in the literature and has been associated with previous influenza vaccinations. Given the timeline of onset after administration of the vaccine, it is difficult to determine whether the vaccine or the possible viral illness was the cause of the ADEM. In correspondence between doctors it was stated that this could be related to the influenza vaccine given in November. Based on an assessment with the Naranjo scale this would be classified as a possible adverse event associated with the administration of the influenza vaccine. Pt was initially treated with dexamethasone but was switched over to a 5 day course of intravenous methylprednisolone after diagnosis of a demyelinating disorder. This was followed up with prednisone taper and aggressive physical therapy. He continues to improve per the notes and has progressed to being able to walk with a cane.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus
Clinical narrative: Oval shaped 4 inches long by 2 inches wide red, not hot to touch and site is itchy.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Eye pain, Hypoaesthesia, Nuclear magnetic resonance imaging brain normal, Pallor, Vomiting
Clinical narrative: Sudden onset numbness in right hand, resolved in 15 minutes.  Then recurred along with eye pain. Became very pale. Vomited.  Second episode on numbness resolved in 30 minutes, and patient recovered completely in about 3 hours.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Eye pruritus, Injection site rash, Injection site urticaria
Clinical narrative: Rash/hives noted to left upper arm and patient c/o her eyes feeling itchy. Denies shortness of breath.  Given oral Benadryl.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Macule, Pruritus, Rash, Rash pruritic
Clinical narrative: Pt developed itching and then later that day noticed a rash on hip flexors, under arms, and then above ankles. Later spread to chest and thighs.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives beginning on left thigh near Kinrix vac site, spreading to both cheeks, right thigh and left arm.  Given 15mg diphenhydramine PO, hives diminished. Patient was up to date with CDC vaccine schedule - this was the first time she had ever received a ProQuad or Kinrix.
Age: 45.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Induration, Oedema peripheral
Clinical narrative: Client had the second dose of VZV on 4/15/13 and her right arm got red and swollen. She felt some induration in the back of the arm. We measure it and the redness was 70 mm long by 50 mm wide. Client called her doctor, who recommended ice compresses. We told client to follow what her doctor prescribed. The redness is subsiding as we could see by the picture client took with her camera-telephone and showed to nurses.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: CSF test abnormal, Creutzfeldt-Jakob disease, Ear congestion, Electroencephalogram abnormal, Erythema
Clinical narrative: This is a concern given the timing of the onset of the second disease.  There is no proof of any association but I feel that the condition is so rare that the timing of the Zostavax vaccination needs to be at least mentioned. The patient and her husband received Zostavax injections in Nov 2012.  The patient developed a small localized erythematous reaction but her husband developed a full shingles reaction/rash to his right forehead which then cleared without event. In late January 2012 the patient started coming in with complaints about fullness in her ears, sinus congestion.  She was treated with antibiotics and finally prednisone.  While on prednisone she started to develop neurologic deficits in 3-15-13 that eventually progressed into major neurologic deficits and finally the diagnosis of Creutzfeld-Jacob Disease via MRI, EEG, and CSF evaluation.  The patient is receiving comfort care at home as I write this and is expected to die within the next week. I am just concerned about the timing of the vaccination and then onset of symptoms and then diagnosis of CJD within 5 months.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Neurological symptom, Nuclear magnetic resonance imaging abnormal, Sinus congestion, Terminal state
Clinical narrative: This is a concern given the timing of the onset of the second disease.  There is no proof of any association but I feel that the condition is so rare that the timing of the Zostavax vaccination needs to be at least mentioned. The patient and her husband received Zostavax injections in Nov 2012.  The patient developed a small localized erythematous reaction but her husband developed a full shingles reaction/rash to his right forehead which then cleared without event. In late January 2012 the patient started coming in with complaints about fullness in her ears, sinus congestion.  She was treated with antibiotics and finally prednisone.  While on prednisone she started to develop neurologic deficits in 3-15-13 that eventually progressed into major neurologic deficits and finally the diagnosis of Creutzfeld-Jacob Disease via MRI, EEG, and CSF evaluation.  The patient is receiving comfort care at home as I write this and is expected to die within the next week. I am just concerned about the timing of the vaccination and then onset of symptoms and then diagnosis of CJD within 5 months.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 weeks old male patient. On 11-MAR-2013, the patient was vaccinated (route not provided) with the first dose of ROTATEQ (lot number and expiry date not provided). The reporter called regarding the dosage schedule of ROTATEQ for an unspecified male patient that received his first dose of ROTATEQ on 11-MAR-2013. ROTATEQ was administered after age 15 weeks. The outcome of administered after 15 weeks of age is unknown. The reporter considered administered after 15 weeks of age to be not related to ROTATEQ. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Vertigo
Clinical narrative: This spontaneous report as received via a company representative from a certified ophthalmic technician at a different office from the treating physician's office: refers to a 63 year old female patient with hypertension, elevated cholesterol, gastroesophageal reflux disease and insomnia. Patient's drug reactions/allergies included penicillin, codeine, CIPRO, amoxicillin, AUGMENTIN, KEFLEX, morphine and mold. On an unspecified date in 2010 the patient was vaccinated with subcutaneously with a standard dose of ZOSTAVAX (lot number, expiry date unspecified). Concomitant therapies included BENICOR 20 mg, PROTONIX, aspirin 81 mg and AMBIEN for insomnia. The patient developed dizziness and vertigo within 24 hours of vaccination with ZOSTAVAX in 2010. The symptoms lasted for approximately 24 hours after onset. The patient had not sought medical attention. No treatment was given. The outcome of vertigo and dizziness was reported as recovered/resolved. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 12-APR-2013 the patient was vaccinated with expired ZOSTAVAX (lot # 0364AE, expire date 16-MAR-2013, dose/frequency and route were unspecified). No adverse event reported. The outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a physician via a company representative concerning her unknown age son who on unknown dates was vaccinated with 2 doses of VARIVAX (Merck) (doses, route and lot numbers not provided). The physician stated that on an unknown date a titer was done to her son after the second dose of VARIVAX (Merck) that showed her son had no titer. The outcome of the event was unknown. The patient sought medical attention with his physician. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via a company representative referred to a patient (age not reported) in 2013 was vaccinated with a dose of ZOSTAVAX (dose not reported), subcutaneous injection for prevention of shingles. In 2013 the patient developed swelling at injection site after receiving ZOSTAVAX, that was tender to the touch. At the time of the report the patient recovered from swelling at injection site. Relationship between swelling at injection site and therapy with ZOSTAVAX was not reported. It was not known if the patient "received the ZOSTAVAX some time last week or some time this week" and it was also not known if this report corresponds to the "male or female patient". This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: This spontaneous report as received from the treating physician's staff secretary via a company representative referred to a patient (age not reported) who in 2013 was vaccinated with a dose of ZOSTAVAX (dose not reported), subcutaneous injection for prevention of shingles. In 2013 the patient developed swelling at injection site after receiving ZOSTAVAX, that was tender to the touch. On an unknown date the patient developed rash and went to first urgent care for treatment. At the time of the report the patient recovered from swelling at injection site, tender to touch. Relationship between swelling at injection site, tender to touch, rash and therapy with ZOSTAVAX was not reported. It was not known if the patient "received the ZOSTAVAX some time last week or some time this week" and it was also not known if this report corresponds to the "male or female patient". This is one of several reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Localised oedema, Pruritus, Skin warm
Clinical narrative: 4/10/13 ER notes 8 cm to 10 cm x 8 cm warm to touch and edematous. No signs of abscess and/or cellulitis. Was given BENADRYL 50mg p.o. helped somewhat of the itching, discharge with BENADRYL prescription.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient with no pertinent medical history or drug allergies. On 05-APR-2013 the patient was subcutaneously vaccinated with a dose of 0.65ml ZOSTAVAX (lot number J000783, expire date 30-APR-2014). There was no concomitant medications. On 06-APR-2013, the patient returned to the pharmacy complaining of swelling, redness and itching at the injection site. The Pharmacist measured the site and it was 3 inches across the upper arm where the injection was given. The patient returned today (on 08-APR-2013) and stated that she had pain, more swelling and redness as well as the site being hot to touch. The site was now 12 inches across the upper arm. The pharmacist also noted that the skin of the arm appeared to be getting rough and changing in texture. The patient was advised to see an unspecified physician. The unspecified physician prescribed an unspecified antibiotic for a diagnosis of cellulitis. The adverse events were reported as not improve. The relatedness for the events to ZOSTAVAX was unknown. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Skin disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient with no pertinent medical history or drug allergies. On 05-APR-2013 the patient was subcutaneously vaccinated with a dose of 0.65ml ZOSTAVAX (lot number J000783, expire date 30-APR-2014). There was no concomitant medications. On 06-APR-2013, the patient returned to the pharmacy complaining of swelling, redness and itching at the injection site. The Pharmacist measured the site and it was 3 inches across the upper arm where the injection was given. The patient returned today (on 08-APR-2013) and stated that she had pain, more swelling and redness as well as the site being hot to touch. The site was now 12 inches across the upper arm. The pharmacist also noted that the skin of the arm appeared to be getting rough and changing in texture. The patient was advised to see an unspecified physician. The unspecified physician prescribed an unspecified antibiotic for a diagnosis of cellulitis. The adverse events were reported as not improve. The relatedness for the events to ZOSTAVAX was unknown. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered pharmacist via Company Representative refers to a 76 year old female patient. In April 2012 the patient was vaccinated SC with a 0.5 ml dose of ZOSTAVAX (lot # not reported). The pharmacist reported that a patient received ZOSTAVAX in April 2012 and later got shingles in the summer of 2012. Varicella zoster virus (VZV) packet declined. At the time of reporting, the outcome was unknown. The relatedness was unknown for ZOSTAVAX. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Headache, Hypoaesthesia, Musculoskeletal pain, Oedema
Clinical narrative: Pain right shoulder, swollen right hand fingers, headaches, numbness in the forearm, pain edema, rubor.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Oedema peripheral, Pain
Clinical narrative: Pain right shoulder, swollen right hand fingers, headaches, numbness in the forearm, pain edema, rubor.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chest pain, Discomfort, Erythema, Headache, Inflammation
Clinical narrative: Pain right shoulder, swollen right hand fingers, headaches, numbness in the forearm, pain edema, rubor.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Local swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain right shoulder, swollen right hand fingers, headaches, numbness in the forearm, pain edema, rubor.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Local reaction, Skin warm
Clinical narrative: Large local reaction 9 x 10cm on (L) arm red warm and spreading over 72 hrs since shot indurated but not tender.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received KINRIX vaccine on right deltoid. Patient came back to office due to red, swelling (R) deltoid. Patient is being treated with KEFLEX twice a day for 10 days and needs to return to office in 2 weeks 4/30/2013 for follow-up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Swelling, redness around the injection site and itching with headache.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 year old male student. The patient was vaccinated IM with the first and second doses of GARDASIL on 07-JUN-2012 and 10-AUG-2012, respectively. On 09-OCT-2012 at 16:30 PM, the patient was vaccinated with the third dose of GARDASIL (lot # 1860AA), intramuscular in the right arm. No adverse effect was reported. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.07
Sex: M
Vaccine: FLU3, HEPA, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 months old male patient. The patient was inadvertently vaccinated with 0.65 ml ZOSTAVAX on left thigh (lot # H018091, expiry date on 04-JAN-2014) instead of VARIVAX (Merck) on 06-DEC-2012. Route was unspecified. Concomitant medications included hepatitis A virus vaccine (manufacturer unspecified), MMR II and influenza virus vaccine (manufacturer unspecified). No adverse effects reported at this time. This is one of several report received from the same source. 1212USA004226. Follow-up information has been received from a registered nurse refers to a patient with no illness at time of vaccination. The patient did not have any pre-existing allergies, birth defects or medical conditions. The patient had one sibling. The patient was vaccinated with the first dose of MMR II (lot number H011906, right thigh, subcutaneous) at 01:47 PM on 06-DEC-2012. Concomitant therapies included the first dose of ZOSTAVAX (lot# H018091, expiry date on 04-JAN-2014) at 01:47 PM on 06-DEC-2012 in left thigh subcutaneously, the first dose of HAVRIX (lot number AHAVB1067AB, left thigh, intramuscular) at 01:47 PM on 06-DEC-2012, and the first dose of FLUZONE (lot number U4488EA, Left thigh, intramuscular) at 01:47 PM on 06-DEC-2012. The patient did not visit the emergency room or doctor. No adverse event was reported. This is one of two reports received from the same patient. MARRS number: 1212USA003114. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Diarrhoea, Electrocardiogram, Erythema, Immunoglobulin therapy, Kawasaki's disease
Clinical narrative: This spontaneous report was received from a consumer refers to his 7 month old male son. No medical history was reported. On 18-SEP-2009, the patient received 3 doses of ROTATEQ (lot#, expiration date and dose, route not reported). On 10-MAR-2011, the patient received 3 more doses of ROTATEQ (lot#, expiration date and dose, route not reported). No concomitant medications were reported. On 15-MAR-2011, the patient was admitted to a Hospital for 20 days (dates unspecified) and was diagnosed with Kawasaki's disease. Patient sought medical attention. Patient received treatment with immunoglobulins. The patient needed to have his tonsils and adenoids removed and also suffered from sleep apnea. Laboratory tests included blood work and Electrocardiogram(EKG)(results not reported). The outcome of Kawasaki's disease and sleep apnea was reported as not recovered. The relatedness of Kawasaki's disease to ROTATEQ was unknown. Legal issue involved-AE sent to legal. Upon internal review, the event Kawasaki's disease was considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Local swelling, Ocular hyperaemia, Oedema peripheral, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a consumer refers to his 7 month old male son. No medical history was reported. On 18-SEP-2009, the patient received 3 doses of ROTATEQ (lot#, expiration date and dose, route not reported). On 10-MAR-2011, the patient received 3 more doses of ROTATEQ (lot#, expiration date and dose, route not reported). No concomitant medications were reported. On 15-MAR-2011, the patient was admitted to a Hospital for 20 days (dates unspecified) and was diagnosed with Kawasaki's disease. Patient sought medical attention. Patient received treatment with immunoglobulins. The patient needed to have his tonsils and adenoids removed and also suffered from sleep apnea. Laboratory tests included blood work and Electrocardiogram(EKG)(results not reported). The outcome of Kawasaki's disease and sleep apnea was reported as not recovered. The relatedness of Kawasaki's disease to ROTATEQ was unknown. Legal issue involved-AE sent to legal. Upon internal review, the event Kawasaki's disease was considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Tongue disorder, X-ray
Clinical narrative: This spontaneous report was received from a consumer refers to his 7 month old male son. No medical history was reported. On 18-SEP-2009, the patient received 3 doses of ROTATEQ (lot#, expiration date and dose, route not reported). On 10-MAR-2011, the patient received 3 more doses of ROTATEQ (lot#, expiration date and dose, route not reported). No concomitant medications were reported. On 15-MAR-2011, the patient was admitted to a Hospital for 20 days (dates unspecified) and was diagnosed with Kawasaki's disease. Patient sought medical attention. Patient received treatment with immunoglobulins. The patient needed to have his tonsils and adenoids removed and also suffered from sleep apnea. Laboratory tests included blood work and Electrocardiogram(EKG)(results not reported). The outcome of Kawasaki's disease and sleep apnea was reported as not recovered. The relatedness of Kawasaki's disease to ROTATEQ was unknown. Legal issue involved-AE sent to legal. Upon internal review, the event Kawasaki's disease was considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Adenotonsillectomy, Blood test, Electrocardiogram, Immunoglobulin therapy, Incorrect dose administered
Clinical narrative: This spontaneous report was received from a consumer refers to his 7 month old male son. No medical history was reported. On 18-SEP-2009, the patient received 3 doses of ROTATEQ (lot#, expiration date and dose, route not reported). On 10-MAR-2011, the patient received 3 more doses of ROTATEQ (lot#, expiration date and dose, route not reported). No concomitant medications were reported. On 15-MAR-2011, the patient was admitted to a Hospital for 20 days (dates unspecified) and was diagnosed with Kawasaki's disease. Patient sought medical attention. Patient received treatment with immunoglobulins. The patient needed to have his tonsils and adenoids removed and also suffered from sleep apnea. Laboratory tests included blood work and Electrocardiogram(EKG)(results not reported). The outcome of Kawasaki's disease and sleep apnea was reported as not recovered. The relatedness of Kawasaki's disease to ROTATEQ was unknown. Legal issue involved-AE sent to legal. Upon internal review, the event Kawasaki's disease was considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Kawasaki's disease, Sleep apnoea syndrome
Clinical narrative: This spontaneous report was received from a consumer refers to his 7 month old male son. No medical history was reported. On 18-SEP-2009, the patient received 3 doses of ROTATEQ (lot#, expiration date and dose, route not reported). On 10-MAR-2011, the patient received 3 more doses of ROTATEQ (lot#, expiration date and dose, route not reported). No concomitant medications were reported. On 15-MAR-2011, the patient was admitted to a Hospital for 20 days (dates unspecified) and was diagnosed with Kawasaki's disease. Patient sought medical attention. Patient received treatment with immunoglobulins. The patient needed to have his tonsils and adenoids removed and also suffered from sleep apnea. Laboratory tests included blood work and Electrocardiogram(EKG)(results not reported). The outcome of Kawasaki's disease and sleep apnea was reported as not recovered. The relatedness of Kawasaki's disease to ROTATEQ was unknown. Legal issue involved-AE sent to legal. Upon internal review, the event Kawasaki's disease was considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Kawasaki's disease, Overdose, Sleep apnoea syndrome
Clinical narrative: This spontaneous report was received from a consumer refers to his 7 month old male son. No medical history was reported. On 18-SEP-2009, the patient received 3 doses of ROTATEQ (lot#, expiration date and dose, route not reported). On 10-MAR-2011, the patient received 3 more doses of ROTATEQ (lot#, expiration date and dose, route not reported). No concomitant medications were reported. On 15-MAR-2011, the patient was admitted to a Hospital for 20 days (dates unspecified) and was diagnosed with Kawasaki's disease. Patient sought medical attention. Patient received treatment with immunoglobulins. The patient needed to have his tonsils and adenoids removed and also suffered from sleep apnea. Laboratory tests included blood work and Electrocardiogram(EKG)(results not reported). The outcome of Kawasaki's disease and sleep apnea was reported as not recovered. The relatedness of Kawasaki's disease to ROTATEQ was unknown. Legal issue involved-AE sent to legal. Upon internal review, the event Kawasaki's disease was considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Diarrhoea, Electrocardiogram, Erythema, Immunoglobulin therapy, Kawasaki's disease
Clinical narrative: This spontaneous report was received from a consumer refers to his 7 month old male son. No medical history was reported. On 18-SEP-2009, the patient received 3 doses of ROTATEQ (lot #, expiration date and dose, route not reported). On 10-MAR-2011, the patient received 3 more doses of ROTATEQ (lot#, expiration date and dose, route not reported). No concomitant medications were reported. On 15-MAR-2011, the patient was admitted to a Hospital for 20 days (dates unspecified) and was diagnosed with Kawasaki's disease. Patient sought medical attention. Patient received treatment with immunoglobulins. The patient needed to have his tonsils and adenoids removed and also suffered from sleep apnea. Laboratory tests included blood work and Electrocardiogram (EKG) (results not reported). The outcome of Kawasaki's disease and sleep apnea was reported as not recovered. The relatedness of Kawasaki's disease to ROTATEQ was unknown. Legal issue involved-AE sent to legal. Upon internal review, the event Kawasaki's disease was considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Local swelling, Ocular hyperaemia, Oedema peripheral, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a consumer refers to his 7 month old male son. No medical history was reported. On 18-SEP-2009, the patient received 3 doses of ROTATEQ (lot #, expiration date and dose, route not reported). On 10-MAR-2011, the patient received 3 more doses of ROTATEQ (lot#, expiration date and dose, route not reported). No concomitant medications were reported. On 15-MAR-2011, the patient was admitted to a Hospital for 20 days (dates unspecified) and was diagnosed with Kawasaki's disease. Patient sought medical attention. Patient received treatment with immunoglobulins. The patient needed to have his tonsils and adenoids removed and also suffered from sleep apnea. Laboratory tests included blood work and Electrocardiogram (EKG) (results not reported). The outcome of Kawasaki's disease and sleep apnea was reported as not recovered. The relatedness of Kawasaki's disease to ROTATEQ was unknown. Legal issue involved-AE sent to legal. Upon internal review, the event Kawasaki's disease was considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Tongue disorder, X-ray
Clinical narrative: This spontaneous report was received from a consumer refers to his 7 month old male son. No medical history was reported. On 18-SEP-2009, the patient received 3 doses of ROTATEQ (lot #, expiration date and dose, route not reported). On 10-MAR-2011, the patient received 3 more doses of ROTATEQ (lot#, expiration date and dose, route not reported). No concomitant medications were reported. On 15-MAR-2011, the patient was admitted to a Hospital for 20 days (dates unspecified) and was diagnosed with Kawasaki's disease. Patient sought medical attention. Patient received treatment with immunoglobulins. The patient needed to have his tonsils and adenoids removed and also suffered from sleep apnea. Laboratory tests included blood work and Electrocardiogram (EKG) (results not reported). The outcome of Kawasaki's disease and sleep apnea was reported as not recovered. The relatedness of Kawasaki's disease to ROTATEQ was unknown. Legal issue involved-AE sent to legal. Upon internal review, the event Kawasaki's disease was considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Adenotonsillectomy, Blood test, Electrocardiogram, Immunoglobulin therapy, Incorrect dose administered
Clinical narrative: This spontaneous report was received from a consumer refers to his 7 month old male son. No medical history was reported. On 18-SEP-2009, the patient received 3 doses of ROTATEQ (lot #, expiration date and dose, route not reported). On 10-MAR-2011, the patient received 3 more doses of ROTATEQ (lot#, expiration date and dose, route not reported). No concomitant medications were reported. On 15-MAR-2011, the patient was admitted to a Hospital for 20 days (dates unspecified) and was diagnosed with Kawasaki's disease. Patient sought medical attention. Patient received treatment with immunoglobulins. The patient needed to have his tonsils and adenoids removed and also suffered from sleep apnea. Laboratory tests included blood work and Electrocardiogram (EKG) (results not reported). The outcome of Kawasaki's disease and sleep apnea was reported as not recovered. The relatedness of Kawasaki's disease to ROTATEQ was unknown. Legal issue involved-AE sent to legal. Upon internal review, the event Kawasaki's disease was considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Kawasaki's disease, Sleep apnoea syndrome
Clinical narrative: This spontaneous report was received from a consumer refers to his 7 month old male son. No medical history was reported. On 18-SEP-2009, the patient received 3 doses of ROTATEQ (lot #, expiration date and dose, route not reported). On 10-MAR-2011, the patient received 3 more doses of ROTATEQ (lot#, expiration date and dose, route not reported). No concomitant medications were reported. On 15-MAR-2011, the patient was admitted to a Hospital for 20 days (dates unspecified) and was diagnosed with Kawasaki's disease. Patient sought medical attention. Patient received treatment with immunoglobulins. The patient needed to have his tonsils and adenoids removed and also suffered from sleep apnea. Laboratory tests included blood work and Electrocardiogram (EKG) (results not reported). The outcome of Kawasaki's disease and sleep apnea was reported as not recovered. The relatedness of Kawasaki's disease to ROTATEQ was unknown. Legal issue involved-AE sent to legal. Upon internal review, the event Kawasaki's disease was considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL, RV5, RV5
Symptoms: Kawasaki's disease, Overdose, Sleep apnoea syndrome
Clinical narrative: This spontaneous report was received from a consumer refers to his 7 month old male son. No medical history was reported. On 18-SEP-2009, the patient received 3 doses of ROTATEQ (lot #, expiration date and dose, route not reported). On 10-MAR-2011, the patient received 3 more doses of ROTATEQ (lot#, expiration date and dose, route not reported). No concomitant medications were reported. On 15-MAR-2011, the patient was admitted to a Hospital for 20 days (dates unspecified) and was diagnosed with Kawasaki's disease. Patient sought medical attention. Patient received treatment with immunoglobulins. The patient needed to have his tonsils and adenoids removed and also suffered from sleep apnea. Laboratory tests included blood work and Electrocardiogram (EKG) (results not reported). The outcome of Kawasaki's disease and sleep apnea was reported as not recovered. The relatedness of Kawasaki's disease to ROTATEQ was unknown. Legal issue involved-AE sent to legal. Upon internal review, the event Kawasaki's disease was considered to be medically significant. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Computerised tomogram, Electroencephalogram, Extremity contracture, Gaze palsy, Muscle rigidity
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 78 year old male patient with no pertinent medical history and no drug reactions or allergies. On 01-MAR-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # H017448, expiration date 20-DEC-2013) subcutaneously. The nurse reported that on approximately 08-MAR-2013, "about 1 week after the vaccination", the patient experienced unspecified seizures and was hospitalized. The patient underwent an extensive work up (results not provided) and was scheduled to see a neurologist. The outcome of seizure was reported as recovered/resolved. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Computerised tomogram, Convulsion, Electrocardiogram, Electroencephalogram, Rotator cuff syndrome
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 78 year old male patient with no pertinent medical history and no drug reactions or allergies. On 01-MAR-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # H017448, expiration date 20-DEC-2013) subcutaneously. The nurse reported that on approximately 08-MAR-2013, "about 1 week after the vaccination", the patient experienced unspecified seizures and was hospitalized. The patient underwent an extensive work up (results not provided) and was scheduled to see a neurologist. The outcome of seizure was reported as recovered/resolved. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Scan with contrast, Tongue biting
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 78 year old male patient with no pertinent medical history and no drug reactions or allergies. On 01-MAR-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # H017448, expiration date 20-DEC-2013) subcutaneously. The nurse reported that on approximately 08-MAR-2013, "about 1 week after the vaccination", the patient experienced unspecified seizures and was hospitalized. The patient underwent an extensive work up (results not provided) and was scheduled to see a neurologist. The outcome of seizure was reported as recovered/resolved. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Convulsion, Laboratory test
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 78 year old male patient with no pertinent medical history and no drug reactions or allergies. On 01-MAR-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # H017448, expiration date 20-DEC-2013) subcutaneously. The nurse reported that on approximately 08-MAR-2013, "about 1 week after the vaccination", the patient experienced unspecified seizures and was hospitalized. The patient underwent an extensive work up (results not provided) and was scheduled to see a neurologist. The outcome of seizure was reported as recovered/resolved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 63 year old female patient regarding herself. The patient had no pertinent medical history, no drug reactions or allergies. On an unknown date in June 2011, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). For the first year the consumer was fine after vaccination but since an unknown date in June 2012 (reported as since last 8 months), the patient has gotten shingles 3 times. No diagnostic test was performed. No treatment was given. The outcome of the reported event was unknown. Additional information has been requested.
Age: 1.56
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Induration, Nodule, Skin warm, Tenderness
Clinical narrative: 1 x 1 inch indurated nodule to (R) thigh slightly warm and tender to touch. TX: BENADRYL syrup, cold water compress.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an approximately 74 year old female patient allergic to penicillin. On an unknown date the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, subcutaneously.The patient who, after receiving ZOSTAVAX, developed a raised knot at the injection site, that looked like a bug bite. The pharmacist did not indicate the color of the knot, but was specific that it was not a rash. The time frame between injection and reaction was unknown, but field representative stated that it was not an immediate reaction to the injection. Field representative also mentioned that decades ago, the patient had a similar reaction to an unspecified penicillin shot (Manufacturer unknown). Patient medical attention by going back to the pharmacy. The outcome of raised knot at the injection site was reported as recovered/resolved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Headache, Injection site rash, Pyrexia
Clinical narrative: Child complains of fever and headache with rash on left upper arm region.  Took Excedrin this morning.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administration error, Incorrect dose administered, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a 51 year old pharmacist (who is also the patient) regarding himself. On an unspecified date, the patient was vaccinated with a less than a full dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant medications were not reported. The patient reported that the ZOSTAVAX, dose felt like it was improperly administered and some of the dose leaked out of the injection site. The injection site became red and sore. The outcome of the reported events were unknown. Additional informaiton is not expected.
Age: 33.0
Sex: M
Vaccine: MMR, TD
Symptoms: Chest X-ray, Headache, Injection site pain, Tuberculin test positive
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 33-year-old male patient with no pertinent medical history and drug reactions/allergies. On 09-APR-2013 the patient was vaccinated with a dose of M-M-R II (lot# H016192, expiration date 31-AUG-2014, route not reported). Other suspect therapies included Tetanus and Diphtheria Toxoids, Adsorbed (reported as TD vaccine manufactured by the company). The patient stated he had pain around the injection site and had been experiencing headaches since receiving a first dose of M-M-R II, the TD vaccine and a Tuberculosis Skin Test (PPD) on the same date (09-APR-2014). The reporter mentioned the patient's Tuberculosis Skin Test (PPD) was positive. The outcome of the events 'pain around the injection site' and 'headaches' were reported as recovering. Treatment was rendered for the events. Ibuprofen and ice to injection site was given. On an unknown date in 2013, chest x-ray was performed for positive Tuberculosis Skin Test (PPD) results unknown). Causality was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 8x10 cm film erythema left upper arm. Increased warmth.