chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt returned to clinic on 3/21/2016 at 8:45am. Parents reported swelling and redness in the L thigh that was first appreciated in the evening on 3/18/16. Pt received DTaP and Hib in the L thigh on 3/18/16. Swelling and redness started to resolve on 3/20/16. Pt did not complain of pain and movement was not impaired. No fever noted. NP assessed patient. This RN discussed with parents what a local reaction meant and that a VAERS report would be filled out. RN instructed parents to notify pediatrician before patient is to receive DTaP again.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Acute respiratory failure, Botulism, Decreased appetite, Dehydration, Metabolic acidosis
Clinical narrative: Low grade fever, increased sleep, decreased appetite and chest congestion.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Muscular weakness, Pyrexia, Respiratory tract congestion, Somnolence
Clinical narrative: Low grade fever, increased sleep, decreased appetite and chest congestion.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant via a company representative referring to a female patient of unknown age. On an unknown date the patient as vaccinated with the first dose of GARDASIL 9 (dose and frequency were not reported) intramuscularly (reported as per label). On an unknown date the patient experienced fainted. The patient stayed at the office for an unspecified amount of time after she fainted. The patient did not experience any injuries from fainting. The patient did receive the complete GARDASIL 9 series on unspecified dates. The outcome of the event was reported as recovered/resolved (unspecified date). Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a patient of unknown age and gender. The medical assistant reported that the patient was vaccinated the first dose in the rotavirus vaccine series with ROTARIX (dose and route not reported) on 14-DEC-2015 at a different location and then the patient came to the current office on 11-MAR-2016 and was vaccinated with second dose in the rotavirus vaccine series with ROTATEQ (lot# L027726, expiration date 10-MAY-2017; dose and route not reported) (interchange of vaccine products). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history and drug reactions/allergies were not reported. On 03-MAR-2016 the patient was vaccinated with an expired dose of M-M-R II (rHA) (dose unknown, lot # K002816, expiration date 25-FEB-2016, subcutaneous) (expired product administered). No known adverse effects were reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a child patient of aged 1-1.5 years old of unknown gender. On an unknown date the patient was vaccinated with M-M-R II injection (dosing regimen and lot # unspecified). No concomitant medications were reported. On an unknown date, 7-10 days after receipt of the M-M-R II, the child broke out in an unspecified rash. Pharmacist did not know any further data and could not provide any additional answers. No further information provided. The outcome of rash was unknown. Causality assessment was not reported. Additional information is not expected. No consent to follow up with the reporter.
Age: 2.0
Sex: F
Vaccine: MMR, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 02-MAR-2016 the patient was vaccinated with PROQUAD (Merck) (strength, lot#, expiration date, dose and route were unknown). Other suspect therapy included VARIVAX (Merck) (strength, lot#, expiration date, dose and route were unknown) which was vaccinated on the same day. No adverse events were reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare student referring to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 17-MAR-2016 the patient was inadvertently administered an expired PNEUMOVAX 23 (lot # K010522 with expiration date 25-FEB-2016, dose and route were unknown). The patient's concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Hyperacusis
Clinical narrative: This spontaneous report was received from a patient's mother regarding her son of unknown age. Information about patient's medical history and drug allergies was not reported. On an unknown date, the patient was vaccinated with M-M-R II (dosing details not reported). It was reported that, on an unspecified date, the patient became "sensitive to some sounds" after vaccination with M-M-R II. She also reported that she had reported this adverse event approximately in 2012 (reported as 4 years ago), but could not find any record of this adverse event report in system. The outcome of hyperacusis and causality were unknown. No PQC was involved. This case is one of the two cases from the same reporter. Additional information has been requested.
Age: 1.31
Sex: M
Vaccine: MMR
Symptoms: Borrelia test negative, Haemorrhage, Immunology test normal, Lymphadenopathy, Polymerase chain reaction
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a currently 1 year old male patient. No medical history and concurrent condition were reported. On 08-DEC-2015, the patient was vaccinated with first dose of MMR II (lot # L008684, expiration date 02-MAR-2017) (strength, dose, frequency and anatomical location unknown). On an unknown date after the vaccination the patient developed a rash and went to see an unspecified dermatologist, who diagnosed the rash to be popular urticarial. On an unknown date the patient had a western blot test and a PCR test for lymph disease and both the tests were negative. On an unknown date, the patient also developed swollen lymph nodes after the vaccination. The reporting physician mentioned that the mother of the patient stated that the patient scratches the rash until he bleeds. The patient sought medical attention by visiting physician office. An unspecified dermatologist prescribed ORAPRED, CLOBETASOL and ZYRTEC (for itching) to treat the events. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. No product quality issue was involved. Additional information has been requested.
Age: 1.31
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Urticaria papular
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a currently 1 year old male patient. No medical history and concurrent condition were reported. On 08-DEC-2015, the patient was vaccinated with first dose of MMR II (lot # L008684, expiration date 02-MAR-2017) (strength, dose, frequency and anatomical location unknown). On an unknown date after the vaccination the patient developed a rash and went to see an unspecified dermatologist, who diagnosed the rash to be popular urticarial. On an unknown date the patient had a western blot test and a PCR test for lymph disease and both the tests were negative. On an unknown date, the patient also developed swollen lymph nodes after the vaccination. The reporting physician mentioned that the mother of the patient stated that the patient scratches the rash until he bleeds. The patient sought medical attention by visiting physician office. An unspecified dermatologist prescribed ORAPRED, CLOBETASOL and ZYRTEC (for itching) to treat the events. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative, Viral titre
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unspecified date(s), the patient was administered an unspecified number of doses of M-M-R II. Concomitant medications were not reported. On an unknown date, the patient had titers drawn which exhibited a "negative immune response". Outcome of the event, action taken with the suspect product and causality was not reported. No product quality (PQC) was involved. Additional information is not expected since the reporter declined to provide any further information and no contacts details provided.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccinated with doses of LIQUID PEDVAXHIB injection, lot # K008681, expiration date 13-MAR-2017 (strength, dose, route and site of administration were not reported), which were exposed to the temperature of 49.1 Fahrenheit degrees for 13.5 hours (cumulative time to the date of reporting). No adverse effect was reported. There were no previous temperature excursions. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug allergies/reactions and concomitant medication were not reported. On 07-MAR-2016, the patient was inadvertently vaccinated with expired dose of PNEUMOVAX 23 (lot # K010523 and expiry date 25-FEB-2016) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Acne, Injection site erythema, Injection site reaction, Injection site vesicles
Clinical narrative: Eleven days after received vaccine, looked like pimple at site. Right thigh with 3-4 small vesicles present with redness.
Age: 1.05
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Erythema, Injection site vesicles, Papule, Rash vesicular
Clinical narrative: 2 weeks after received vaccine started with blister at vaccine site. On day of eval had red papules on anterior thigh some with vesicular appearance.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anal sphincter atony, Asthenia, Blood glucose normal, CSF myelin basic protein increased, CSF protein increased
Clinical narrative: Initial unsolicited report received from the literature on 09 march 2016. This case involves a (age and gender not reported) patient who was vaccinated with a dose of Influenza Vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced acute transverse myelitis. Laboratory investigation involved T1 weighted MRIs showed diffuse, fusiform spinal cord enlargement, extending from C3 to rostral thoracic levels. Intramedullary lesions containing increased T2 signal were found in the areas of cord enlargement. Corrective treatment was not reported. The outcome of event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event acute transverse myelitis. List of documents held by sender: none. Follow up information received from Literature on 11 March 2016. This case involves 36-year-old female patient who was vaccinated with 0.5 ml influenza vaccine. On an unspecified date, four weeks following the vaccination, the patient had experienced progressive leg weakness, numbness below the chest and urinary retention. The patient had not experienced antecedent illness, the vaccination had been tolerated. On an unspecified date, the patient had also experienced minimal bowel incontinence and occasional exercise induced leg paresthesias. Laboratory date included-Neurological examinations showed mild to moderate weakness and hyperreflexia of the lower extremities, a discrete sensory deficit below the T-3 level and decrease in rectal tone. The MRI (spin-echo) of vical and rostral thoracic spin showed mild diffusion fusiform enlargement of the spinal cord extending from C-3 to upper thoracic level and confluent intramedullary lesions containing increased T2 signals. The contrast gadopentete dimeglumine (intravenous) was administered, showed no abnormal enhancement. In cerebrospinal fluid, White blood cells - 84, lymphocytes- 90 percent, monocytes- 10 percent, erythrocytes- 3, total protein- 96 mg/dl, glucose level- normal,myelin basic protein- 6 ng/ml. The corrective treatment includes methylprednisolone (intravenous) (1 gm/day for 5 days). On an unspecified date, one year after the onset of events, the patient was recovered from events. Sender's Comments: Follow-up received on 11-Mar-2016, changes the medical assessment of the case as below. Four weeks after vaccination with Influenza vaccine Acute Transverse Myelitis with leg weakness, numbness below the chest, urinary retention were reported. Influenza vaccine is known to cause neurological complications. In the absence of any alternative explanation and the known safety profile of the vaccine, the contributory role of the vaccine in the occurrence of the reported events cannot be ruled out.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: CSF red blood cell count positive, CSF test abnormal, CSF white blood cell count increased, Faecal incontinence, Hyperreflexia
Clinical narrative: Initial unsolicited report received from the literature on 09 march 2016. This case involves a (age and gender not reported) patient who was vaccinated with a dose of Influenza Vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced acute transverse myelitis. Laboratory investigation involved T1 weighted MRIs showed diffuse, fusiform spinal cord enlargement, extending from C3 to rostral thoracic levels. Intramedullary lesions containing increased T2 signal were found in the areas of cord enlargement. Corrective treatment was not reported. The outcome of event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event acute transverse myelitis. List of documents held by sender: none. Follow up information received from Literature on 11 March 2016. This case involves 36-year-old female patient who was vaccinated with 0.5 ml influenza vaccine. On an unspecified date, four weeks following the vaccination, the patient had experienced progressive leg weakness, numbness below the chest and urinary retention. The patient had not experienced antecedent illness, the vaccination had been tolerated. On an unspecified date, the patient had also experienced minimal bowel incontinence and occasional exercise induced leg paresthesias. Laboratory date included-Neurological examinations showed mild to moderate weakness and hyperreflexia of the lower extremities, a discrete sensory deficit below the T-3 level and decrease in rectal tone. The MRI (spin-echo) of vical and rostral thoracic spin showed mild diffusion fusiform enlargement of the spinal cord extending from C-3 to upper thoracic level and confluent intramedullary lesions containing increased T2 signals. The contrast gadopentete dimeglumine (intravenous) was administered, showed no abnormal enhancement. In cerebrospinal fluid, White blood cells - 84, lymphocytes- 90 percent, monocytes- 10 percent, erythrocytes- 3, total protein- 96 mg/dl, glucose level- normal,myelin basic protein- 6 ng/ml. The corrective treatment includes methylprednisolone (intravenous) (1 gm/day for 5 days). On an unspecified date, one year after the onset of events, the patient was recovered from events. Sender's Comments: Follow-up received on 11-Mar-2016, changes the medical assessment of the case as below. Four weeks after vaccination with Influenza vaccine Acute Transverse Myelitis with leg weakness, numbness below the chest, urinary retention were reported. Influenza vaccine is known to cause neurological complications. In the absence of any alternative explanation and the known safety profile of the vaccine, the contributory role of the vaccine in the occurrence of the reported events cannot be ruled out.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hypoaesthesia, Lymphocyte percentage increased, Monocyte percentage increased, Muscular weakness, Myelitis transverse
Clinical narrative: Initial unsolicited report received from the literature on 09 march 2016. This case involves a (age and gender not reported) patient who was vaccinated with a dose of Influenza Vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced acute transverse myelitis. Laboratory investigation involved T1 weighted MRIs showed diffuse, fusiform spinal cord enlargement, extending from C3 to rostral thoracic levels. Intramedullary lesions containing increased T2 signal were found in the areas of cord enlargement. Corrective treatment was not reported. The outcome of event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event acute transverse myelitis. List of documents held by sender: none. Follow up information received from Literature on 11 March 2016. This case involves 36-year-old female patient who was vaccinated with 0.5 ml influenza vaccine. On an unspecified date, four weeks following the vaccination, the patient had experienced progressive leg weakness, numbness below the chest and urinary retention. The patient had not experienced antecedent illness, the vaccination had been tolerated. On an unspecified date, the patient had also experienced minimal bowel incontinence and occasional exercise induced leg paresthesias. Laboratory date included-Neurological examinations showed mild to moderate weakness and hyperreflexia of the lower extremities, a discrete sensory deficit below the T-3 level and decrease in rectal tone. The MRI (spin-echo) of vical and rostral thoracic spin showed mild diffusion fusiform enlargement of the spinal cord extending from C-3 to upper thoracic level and confluent intramedullary lesions containing increased T2 signals. The contrast gadopentete dimeglumine (intravenous) was administered, showed no abnormal enhancement. In cerebrospinal fluid, White blood cells - 84, lymphocytes- 90 percent, monocytes- 10 percent, erythrocytes- 3, total protein- 96 mg/dl, glucose level- normal,myelin basic protein- 6 ng/ml. The corrective treatment includes methylprednisolone (intravenous) (1 gm/day for 5 days). On an unspecified date, one year after the onset of events, the patient was recovered from events. Sender's Comments: Follow-up received on 11-Mar-2016, changes the medical assessment of the case as below. Four weeks after vaccination with Influenza vaccine Acute Transverse Myelitis with leg weakness, numbness below the chest, urinary retention were reported. Influenza vaccine is known to cause neurological complications. In the absence of any alternative explanation and the known safety profile of the vaccine, the contributory role of the vaccine in the occurrence of the reported events cannot be ruled out.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Myelopathy, Neurological examination abnormal, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia
Clinical narrative: Initial unsolicited report received from the literature on 09 march 2016. This case involves a (age and gender not reported) patient who was vaccinated with a dose of Influenza Vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced acute transverse myelitis. Laboratory investigation involved T1 weighted MRIs showed diffuse, fusiform spinal cord enlargement, extending from C3 to rostral thoracic levels. Intramedullary lesions containing increased T2 signal were found in the areas of cord enlargement. Corrective treatment was not reported. The outcome of event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event acute transverse myelitis. List of documents held by sender: none. Follow up information received from Literature on 11 March 2016. This case involves 36-year-old female patient who was vaccinated with 0.5 ml influenza vaccine. On an unspecified date, four weeks following the vaccination, the patient had experienced progressive leg weakness, numbness below the chest and urinary retention. The patient had not experienced antecedent illness, the vaccination had been tolerated. On an unspecified date, the patient had also experienced minimal bowel incontinence and occasional exercise induced leg paresthesias. Laboratory date included-Neurological examinations showed mild to moderate weakness and hyperreflexia of the lower extremities, a discrete sensory deficit below the T-3 level and decrease in rectal tone. The MRI (spin-echo) of vical and rostral thoracic spin showed mild diffusion fusiform enlargement of the spinal cord extending from C-3 to upper thoracic level and confluent intramedullary lesions containing increased T2 signals. The contrast gadopentete dimeglumine (intravenous) was administered, showed no abnormal enhancement. In cerebrospinal fluid, White blood cells - 84, lymphocytes- 90 percent, monocytes- 10 percent, erythrocytes- 3, total protein- 96 mg/dl, glucose level- normal,myelin basic protein- 6 ng/ml. The corrective treatment includes methylprednisolone (intravenous) (1 gm/day for 5 days). On an unspecified date, one year after the onset of events, the patient was recovered from events. Sender's Comments: Follow-up received on 11-Mar-2016, changes the medical assessment of the case as below. Four weeks after vaccination with Influenza vaccine Acute Transverse Myelitis with leg weakness, numbness below the chest, urinary retention were reported. Influenza vaccine is known to cause neurological complications. In the absence of any alternative explanation and the known safety profile of the vaccine, the contributory role of the vaccine in the occurrence of the reported events cannot be ruled out.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Post vaccination syndrome, Sensory loss, Spinal cord oedema, Urinary retention
Clinical narrative: Initial unsolicited report received from the literature on 09 march 2016. This case involves a (age and gender not reported) patient who was vaccinated with a dose of Influenza Vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced acute transverse myelitis. Laboratory investigation involved T1 weighted MRIs showed diffuse, fusiform spinal cord enlargement, extending from C3 to rostral thoracic levels. Intramedullary lesions containing increased T2 signal were found in the areas of cord enlargement. Corrective treatment was not reported. The outcome of event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event acute transverse myelitis. List of documents held by sender: none. Follow up information received from Literature on 11 March 2016. This case involves 36-year-old female patient who was vaccinated with 0.5 ml influenza vaccine. On an unspecified date, four weeks following the vaccination, the patient had experienced progressive leg weakness, numbness below the chest and urinary retention. The patient had not experienced antecedent illness, the vaccination had been tolerated. On an unspecified date, the patient had also experienced minimal bowel incontinence and occasional exercise induced leg paresthesias. Laboratory date included-Neurological examinations showed mild to moderate weakness and hyperreflexia of the lower extremities, a discrete sensory deficit below the T-3 level and decrease in rectal tone. The MRI (spin-echo) of vical and rostral thoracic spin showed mild diffusion fusiform enlargement of the spinal cord extending from C-3 to upper thoracic level and confluent intramedullary lesions containing increased T2 signals. The contrast gadopentete dimeglumine (intravenous) was administered, showed no abnormal enhancement. In cerebrospinal fluid, White blood cells - 84, lymphocytes- 90 percent, monocytes- 10 percent, erythrocytes- 3, total protein- 96 mg/dl, glucose level- normal,myelin basic protein- 6 ng/ml. The corrective treatment includes methylprednisolone (intravenous) (1 gm/day for 5 days). On an unspecified date, one year after the onset of events, the patient was recovered from events. Sender's Comments: Follow-up received on 11-Mar-2016, changes the medical assessment of the case as below. Four weeks after vaccination with Influenza vaccine Acute Transverse Myelitis with leg weakness, numbness below the chest, urinary retention were reported. Influenza vaccine is known to cause neurological complications. In the absence of any alternative explanation and the known safety profile of the vaccine, the contributory role of the vaccine in the occurrence of the reported events cannot be ruled out.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anal sphincter atony, CSF glucose normal, CSF myelin basic protein normal, CSF protein increased, CSF red blood cell count positive
Clinical narrative: Initial unsolicited report received from the literature on 09 march 2016. This case involves a (age and gender not reported) patient who was vaccinated with a dose of Influenza Vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced acute transverse myelitis. Laboratory investigation involved T1 weighted MRIs showed diffuse, fusiform spinal cord enlargement, extending from C3 to rostral thoracic levels. Intramedullary lesions containing increased T2 signal were found in the areas of cord enlargement. Corrective treatment was not reported. The outcome of event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event acute transverse myelitis. List of documents held by sender: none. Follow up information received from Literature on 11 March 2016. This case involves 36-year-old female patient who was vaccinated with 0.5 ml influenza vaccine. On an unspecified date, four weeks following the vaccination, the patient had experienced progressive leg weakness, numbness below the chest and urinary retention. The patient had not experienced antecedent illness, the vaccination had been tolerated. On an unspecified date, the patient had also experienced minimal bowel incontinence and occasional exercise induced leg paresthesias. Laboratory date included-Neurological examinations showed mild to moderate weakness and hyperreflexia of the lower extremities, a discrete sensory deficit below the T-3 level and decrease in rectal tone. The MRI (spin-echo) of vical and rostral thoracic spin showed mild diffusion fusiform enlargement of the spinal cord extending from C-3 to upper thoracic level and confluent intramedullary lesions containing increased T2 signals. The contrast gadopentete dimeglumine (intravenous) was administered, showed no abnormal enhancement. In cerebrospinal fluid, White blood cells - 84, lymphocytes- 90 percent, monocytes- 10 percent, erythrocytes- 3, total protein- 96 mg/dl, glucose level- normal,myelin basic protein- 6 ng/ml. The corrective treatment includes methylprednisolone (intravenous) (1 gm/day for 5 days). On an unspecified date, one year after the onset of events, the patient was recovered from events. Sender's Comments: Follow-up received on 11-Mar-2016, changes the medical assessment of the case as below. Four weeks after vaccination with Influenza vaccine Acute Transverse Myelitis with leg weakness, numbness below the chest, urinary retention were reported. Influenza vaccine is known to cause neurological complications. In the absence of any alternative explanation and the known safety profile of the vaccine, the contributory role of the vaccine in the occurrence of the reported events cannot be ruled out.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: CSF white blood cell count increased, Central nervous system lesion, Faecal incontinence, Hyperreflexia, Hypoaesthesia
Clinical narrative: Initial unsolicited report received from the literature on 09 march 2016. This case involves a (age and gender not reported) patient who was vaccinated with a dose of Influenza Vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced acute transverse myelitis. Laboratory investigation involved T1 weighted MRIs showed diffuse, fusiform spinal cord enlargement, extending from C3 to rostral thoracic levels. Intramedullary lesions containing increased T2 signal were found in the areas of cord enlargement. Corrective treatment was not reported. The outcome of event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event acute transverse myelitis. List of documents held by sender: none. Follow up information received from Literature on 11 March 2016. This case involves 36-year-old female patient who was vaccinated with 0.5 ml influenza vaccine. On an unspecified date, four weeks following the vaccination, the patient had experienced progressive leg weakness, numbness below the chest and urinary retention. The patient had not experienced antecedent illness, the vaccination had been tolerated. On an unspecified date, the patient had also experienced minimal bowel incontinence and occasional exercise induced leg paresthesias. Laboratory date included-Neurological examinations showed mild to moderate weakness and hyperreflexia of the lower extremities, a discrete sensory deficit below the T-3 level and decrease in rectal tone. The MRI (spin-echo) of vical and rostral thoracic spin showed mild diffusion fusiform enlargement of the spinal cord extending from C-3 to upper thoracic level and confluent intramedullary lesions containing increased T2 signals. The contrast gadopentete dimeglumine (intravenous) was administered, showed no abnormal enhancement. In cerebrospinal fluid, White blood cells - 84, lymphocytes- 90 percent, monocytes- 10 percent, erythrocytes- 3, total protein- 96 mg/dl, glucose level- normal,myelin basic protein- 6 ng/ml. The corrective treatment includes methylprednisolone (intravenous) (1 gm/day for 5 days). On an unspecified date, one year after the onset of events, the patient was recovered from events. Sender's Comments: Follow-up received on 11-Mar-2016, changes the medical assessment of the case as below. Four weeks after vaccination with Influenza vaccine Acute Transverse Myelitis with leg weakness, numbness below the chest, urinary retention were reported. Influenza vaccine is known to cause neurological complications. In the absence of any alternative explanation and the known safety profile of the vaccine, the contributory role of the vaccine in the occurrence of the reported events cannot be ruled out.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Lymphocyte percentage increased, Monocyte percentage increased, Muscular weakness, Myelitis transverse, Nervous system disorder
Clinical narrative: Initial unsolicited report received from the literature on 09 march 2016. This case involves a (age and gender not reported) patient who was vaccinated with a dose of Influenza Vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced acute transverse myelitis. Laboratory investigation involved T1 weighted MRIs showed diffuse, fusiform spinal cord enlargement, extending from C3 to rostral thoracic levels. Intramedullary lesions containing increased T2 signal were found in the areas of cord enlargement. Corrective treatment was not reported. The outcome of event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event acute transverse myelitis. List of documents held by sender: none. Follow up information received from Literature on 11 March 2016. This case involves 36-year-old female patient who was vaccinated with 0.5 ml influenza vaccine. On an unspecified date, four weeks following the vaccination, the patient had experienced progressive leg weakness, numbness below the chest and urinary retention. The patient had not experienced antecedent illness, the vaccination had been tolerated. On an unspecified date, the patient had also experienced minimal bowel incontinence and occasional exercise induced leg paresthesias. Laboratory date included-Neurological examinations showed mild to moderate weakness and hyperreflexia of the lower extremities, a discrete sensory deficit below the T-3 level and decrease in rectal tone. The MRI (spin-echo) of vical and rostral thoracic spin showed mild diffusion fusiform enlargement of the spinal cord extending from C-3 to upper thoracic level and confluent intramedullary lesions containing increased T2 signals. The contrast gadopentete dimeglumine (intravenous) was administered, showed no abnormal enhancement. In cerebrospinal fluid, White blood cells - 84, lymphocytes- 90 percent, monocytes- 10 percent, erythrocytes- 3, total protein- 96 mg/dl, glucose level- normal,myelin basic protein- 6 ng/ml. The corrective treatment includes methylprednisolone (intravenous) (1 gm/day for 5 days). On an unspecified date, one year after the onset of events, the patient was recovered from events. Sender's Comments: Follow-up received on 11-Mar-2016, changes the medical assessment of the case as below. Four weeks after vaccination with Influenza vaccine Acute Transverse Myelitis with leg weakness, numbness below the chest, urinary retention were reported. Influenza vaccine is known to cause neurological complications. In the absence of any alternative explanation and the known safety profile of the vaccine, the contributory role of the vaccine in the occurrence of the reported events cannot be ruled out.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Neurological examination abnormal, Nuclear magnetic resonance imaging spinal abnormal, Paraesthesia, Sensory loss, Spinal cord oedema
Clinical narrative: Initial unsolicited report received from the literature on 09 march 2016. This case involves a (age and gender not reported) patient who was vaccinated with a dose of Influenza Vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced acute transverse myelitis. Laboratory investigation involved T1 weighted MRIs showed diffuse, fusiform spinal cord enlargement, extending from C3 to rostral thoracic levels. Intramedullary lesions containing increased T2 signal were found in the areas of cord enlargement. Corrective treatment was not reported. The outcome of event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event acute transverse myelitis. List of documents held by sender: none. Follow up information received from Literature on 11 March 2016. This case involves 36-year-old female patient who was vaccinated with 0.5 ml influenza vaccine. On an unspecified date, four weeks following the vaccination, the patient had experienced progressive leg weakness, numbness below the chest and urinary retention. The patient had not experienced antecedent illness, the vaccination had been tolerated. On an unspecified date, the patient had also experienced minimal bowel incontinence and occasional exercise induced leg paresthesias. Laboratory date included-Neurological examinations showed mild to moderate weakness and hyperreflexia of the lower extremities, a discrete sensory deficit below the T-3 level and decrease in rectal tone. The MRI (spin-echo) of vical and rostral thoracic spin showed mild diffusion fusiform enlargement of the spinal cord extending from C-3 to upper thoracic level and confluent intramedullary lesions containing increased T2 signals. The contrast gadopentete dimeglumine (intravenous) was administered, showed no abnormal enhancement. In cerebrospinal fluid, White blood cells - 84, lymphocytes- 90 percent, monocytes- 10 percent, erythrocytes- 3, total protein- 96 mg/dl, glucose level- normal,myelin basic protein- 6 ng/ml. The corrective treatment includes methylprednisolone (intravenous) (1 gm/day for 5 days). On an unspecified date, one year after the onset of events, the patient was recovered from events. Sender's Comments: Follow-up received on 11-Mar-2016, changes the medical assessment of the case as below. Four weeks after vaccination with Influenza vaccine Acute Transverse Myelitis with leg weakness, numbness below the chest, urinary retention were reported. Influenza vaccine is known to cause neurological complications. In the absence of any alternative explanation and the known safety profile of the vaccine, the contributory role of the vaccine in the occurrence of the reported events cannot be ruled out.
Age: 36.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Urinary retention
Clinical narrative: Initial unsolicited report received from the literature on 09 march 2016. This case involves a (age and gender not reported) patient who was vaccinated with a dose of Influenza Vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced acute transverse myelitis. Laboratory investigation involved T1 weighted MRIs showed diffuse, fusiform spinal cord enlargement, extending from C3 to rostral thoracic levels. Intramedullary lesions containing increased T2 signal were found in the areas of cord enlargement. Corrective treatment was not reported. The outcome of event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event acute transverse myelitis. List of documents held by sender: none. Follow up information received from Literature on 11 March 2016. This case involves 36-year-old female patient who was vaccinated with 0.5 ml influenza vaccine. On an unspecified date, four weeks following the vaccination, the patient had experienced progressive leg weakness, numbness below the chest and urinary retention. The patient had not experienced antecedent illness, the vaccination had been tolerated. On an unspecified date, the patient had also experienced minimal bowel incontinence and occasional exercise induced leg paresthesias. Laboratory date included-Neurological examinations showed mild to moderate weakness and hyperreflexia of the lower extremities, a discrete sensory deficit below the T-3 level and decrease in rectal tone. The MRI (spin-echo) of vical and rostral thoracic spin showed mild diffusion fusiform enlargement of the spinal cord extending from C-3 to upper thoracic level and confluent intramedullary lesions containing increased T2 signals. The contrast gadopentete dimeglumine (intravenous) was administered, showed no abnormal enhancement. In cerebrospinal fluid, White blood cells - 84, lymphocytes- 90 percent, monocytes- 10 percent, erythrocytes- 3, total protein- 96 mg/dl, glucose level- normal,myelin basic protein- 6 ng/ml. The corrective treatment includes methylprednisolone (intravenous) (1 gm/day for 5 days). On an unspecified date, one year after the onset of events, the patient was recovered from events. Sender's Comments: Follow-up received on 11-Mar-2016, changes the medical assessment of the case as below. Four weeks after vaccination with Influenza vaccine Acute Transverse Myelitis with leg weakness, numbness below the chest, urinary retention were reported. Influenza vaccine is known to cause neurological complications. In the absence of any alternative explanation and the known safety profile of the vaccine, the contributory role of the vaccine in the occurrence of the reported events cannot be ruled out.
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and itching at injection site.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Blood test, Chest pain, Dizziness, Electrocardiogram
Clinical narrative: General Feeling Bad, Chronic Fatigue, Severe Headaches, Dizziness, Heart Palpitations, Tachycardia, Syncope, Chest Pain, Itchy and numbness in hands and feet, Brain fog, difficulty remembering things. These symptoms have come and gone since June 2013 with extreme fatigue worsening November 2014 causing to be withdrawn from school. Started IV Therapy treatment December 2015 containing high doses of Vitamin C and chelation materials.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Feeling abnormal, Headache, Hypoaesthesia, Immunology test
Clinical narrative: General Feeling Bad, Chronic Fatigue, Severe Headaches, Dizziness, Heart Palpitations, Tachycardia, Syncope, Chest Pain, Itchy and numbness in hands and feet, Brain fog, difficulty remembering things. These symptoms have come and gone since June 2013 with extreme fatigue worsening November 2014 causing to be withdrawn from school. Started IV Therapy treatment December 2015 containing high doses of Vitamin C and chelation materials.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inflammatory marker test, Memory impairment, Mononucleosis heterophile test, Palpitations, Pruritus
Clinical narrative: General Feeling Bad, Chronic Fatigue, Severe Headaches, Dizziness, Heart Palpitations, Tachycardia, Syncope, Chest Pain, Itchy and numbness in hands and feet, Brain fog, difficulty remembering things. These symptoms have come and gone since June 2013 with extreme fatigue worsening November 2014 causing to be withdrawn from school. Started IV Therapy treatment December 2015 containing high doses of Vitamin C and chelation materials.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tachycardia, Ultrasound scan
Clinical narrative: General Feeling Bad, Chronic Fatigue, Severe Headaches, Dizziness, Heart Palpitations, Tachycardia, Syncope, Chest Pain, Itchy and numbness in hands and feet, Brain fog, difficulty remembering things. These symptoms have come and gone since June 2013 with extreme fatigue worsening November 2014 causing to be withdrawn from school. Started IV Therapy treatment December 2015 containing high doses of Vitamin C and chelation materials.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received ZOSTAVAX in left arm on 3/17/16. On 3/18/16 (in the evening). Patient woke up with swelling, itchiness and a lump at injection site. The itchiness/swelling resolved over the next two days and patient is feeling fine, as of 3/21/16.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 29-OCT-2015, the patient was vaccinated with GARDASIL first dose (lot number, expiry date, dosage and route were not reported). On 21-DEC-2015, patient was vaccinated with GARDASIL second dose (lot number, expiry date, dosage and route were not reported). On 29-FEB-2016, the patient was administered in less than the recommended interval with the third dose (inappropriate schedule of drug administration) of the GARDASIL lot# K009482 (expiry date: 06-MAR-2017). No adverse effects were reported. There were no product quality complaints (PQC) involved. No further information provided. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a other health professional via other manufacturer and described the occurrence of rash in a female patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to Hepatitis B vaccine. Additional details were provided as follows: This case been linked to other case which contains pharma suspects linked to respective allergies.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccinated with doses of M-M-R II, injection, lot # L007216, expiration date 03-MAR-2017 (strength, dose, route and site of administration were not reported), which were exposed to the temperature of 49.1 Fahrenheit degrees for 13.5 hours. No adverse effect was reported. There were not previous temperature excursions. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.