chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Vision blurred, Wheelchair user, White blood cell count normal
Clinical narrative: Pt. received TRUMENBA 8/9/16 at 10 AM and dev. fever at 4pm and severe HA tx'ed with ibu/TYL. Pt. c/o arm swelling around injection site, eye pain, and left-sided numbness extending to her teeth. Pt. also c/o nausea. No V/D. HA cont. to worsen but fever resolved after 48 hrs. Pt. presented to ER for eval. on  8/11 PM. Pt. c/o HA, fever (T max 102 x 2 days), and photophobia/phonophobia/blurry vision. Started ALLEGRA. No hx of rash. No tick exposure. In ER, pt. underwent LP-CSF-4 WBC/4 nucleated cells/RBC 6/nl. glucose/nl. protein/neg. Gram stain. Nl. CBC -  WBC 7.9, hemoglobin 12.8, hematocrit 39, platelet 178. Nl. CMP. Pt. dc'ed home on doxy 100 bid x 14 days and ZOFRAN prn. Pt. returned to ER on 8/14 with persistent sx and dev. of numbness/tingling in legs along with LE weakness. She received non contrast CT of head - WNL, Nl. CBC, BMP, and neg Monospot. She was given migraine "cocktail" of -IVF, BENADRYL, COMPAZINE, TORADOL and MgSO4 with min. relief. Pt. with LE weakness and 1+ reflexes. LE sensation was intact. Neurology consulted - sx  ?ly due to post - LP NA vs GBS. MRI of brain and spine - WNL  Pt. dc/ed home. Pt. cont. to c/o HA, nausea and lower ext. weakness/numbness. Seen in PCP office on 8/22 and 8/27 and numerous phone calls to office. Pt. seen by neurology and started on gabapentin 300 mg tid and written to have OT/PT 2x/week. Pt.'s sx are persistent - she will attend school in a wheelchair. Pt. with hx of dermoid cyst as infant behind Rt. eye and has a fistula leading out of orbit - followed with yearly CT scans of head by Neurosurgery. Hx of orbital abscess. Last head CT (12/15) - WNL. Hx of 2 concussions in 2014 with subsequent post concussive HA's that gradually resolved.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Blood test normal, Computerised tomogram normal, Fatigue, Feeding disorder, Headache
Clinical narrative: Pt. received TRUMENBA 8/9/16 at 10 AM and dev. fever at 4pm and severe HA tx'ed with ibu/TYL. Pt. c/o arm swelling around injection site, eye pain, and left-sided numbness extending to her teeth. Pt. also c/o nausea. No V/D. HA cont. to worsen but fever resolved after 48 hrs. Pt. presented to ER for eval. on  8/11 PM. Pt. c/o HA, fever (T max 102 x 2 days), and photophobia/phonophobia/blurry vision. Started ALLEGRA. No hx of rash. No tick exposure. In ER, pt. underwent LP-CSF-4 WBC/4 nucleated cells/RBC 6/nl. glucose/nl. protein/neg. Gram stain. Nl. CBC -  WBC 7.9, hemoglobin 12.8, hematocrit 39, platelet 178. Nl. CMP. Pt. dc'ed home on doxy 100 bid x 14 days and ZOFRAN prn. Pt. returned to ER on 8/14 with persistent sx and dev. of numbness/tingling in legs along with LE weakness. She received non contrast CT of head - WNL, Nl. CBC, BMP, and neg Monospot. She was given migraine "cocktail" of -IVF, BENADRYL, COMPAZINE, TORADOL and MgSO4 with min. relief. Pt. with LE weakness and 1+ reflexes. LE sensation was intact. Neurology consulted - sx  ?ly due to post - LP NA vs GBS. MRI of brain and spine - WNL  Pt. dc/ed home. Pt. cont. to c/o HA, nausea and lower ext. weakness/numbness. Seen in PCP office on 8/22 and 8/27 and numerous phone calls to office. Pt. seen by neurology and started on gabapentin 300 mg tid and written to have OT/PT 2x/week. Pt.'s sx are persistent - she will attend school in a wheelchair. Pt. with hx of dermoid cyst as infant behind Rt. eye and has a fistula leading out of orbit - followed with yearly CT scans of head by Neurosurgery. Hx of orbital abscess. Last head CT (12/15) - WNL. Hx of 2 concussions in 2014 with subsequent post concussive HA's that gradually resolved.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Hemiparesis, Lumbar puncture normal, Malaise, Migraine, Mononucleosis heterophile test negative
Clinical narrative: Pt. received TRUMENBA 8/9/16 at 10 AM and dev. fever at 4pm and severe HA tx'ed with ibu/TYL. Pt. c/o arm swelling around injection site, eye pain, and left-sided numbness extending to her teeth. Pt. also c/o nausea. No V/D. HA cont. to worsen but fever resolved after 48 hrs. Pt. presented to ER for eval. on  8/11 PM. Pt. c/o HA, fever (T max 102 x 2 days), and photophobia/phonophobia/blurry vision. Started ALLEGRA. No hx of rash. No tick exposure. In ER, pt. underwent LP-CSF-4 WBC/4 nucleated cells/RBC 6/nl. glucose/nl. protein/neg. Gram stain. Nl. CBC -  WBC 7.9, hemoglobin 12.8, hematocrit 39, platelet 178. Nl. CMP. Pt. dc'ed home on doxy 100 bid x 14 days and ZOFRAN prn. Pt. returned to ER on 8/14 with persistent sx and dev. of numbness/tingling in legs along with LE weakness. She received non contrast CT of head - WNL, Nl. CBC, BMP, and neg Monospot. She was given migraine "cocktail" of -IVF, BENADRYL, COMPAZINE, TORADOL and MgSO4 with min. relief. Pt. with LE weakness and 1+ reflexes. LE sensation was intact. Neurology consulted - sx  ?ly due to post - LP NA vs GBS. MRI of brain and spine - WNL  Pt. dc/ed home. Pt. cont. to c/o HA, nausea and lower ext. weakness/numbness. Seen in PCP office on 8/22 and 8/27 and numerous phone calls to office. Pt. seen by neurology and started on gabapentin 300 mg tid and written to have OT/PT 2x/week. Pt.'s sx are persistent - she will attend school in a wheelchair. Pt. with hx of dermoid cyst as infant behind Rt. eye and has a fistula leading out of orbit - followed with yearly CT scans of head by Neurosurgery. Hx of orbital abscess. Last head CT (12/15) - WNL. Hx of 2 concussions in 2014 with subsequent post concussive HA's that gradually resolved.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Muscular weakness, Nausea, Nuclear magnetic resonance imaging normal, Pain, Paraesthesia
Clinical narrative: Pt. received TRUMENBA 8/9/16 at 10 AM and dev. fever at 4pm and severe HA tx'ed with ibu/TYL. Pt. c/o arm swelling around injection site, eye pain, and left-sided numbness extending to her teeth. Pt. also c/o nausea. No V/D. HA cont. to worsen but fever resolved after 48 hrs. Pt. presented to ER for eval. on  8/11 PM. Pt. c/o HA, fever (T max 102 x 2 days), and photophobia/phonophobia/blurry vision. Started ALLEGRA. No hx of rash. No tick exposure. In ER, pt. underwent LP-CSF-4 WBC/4 nucleated cells/RBC 6/nl. glucose/nl. protein/neg. Gram stain. Nl. CBC -  WBC 7.9, hemoglobin 12.8, hematocrit 39, platelet 178. Nl. CMP. Pt. dc'ed home on doxy 100 bid x 14 days and ZOFRAN prn. Pt. returned to ER on 8/14 with persistent sx and dev. of numbness/tingling in legs along with LE weakness. She received non contrast CT of head - WNL, Nl. CBC, BMP, and neg Monospot. She was given migraine "cocktail" of -IVF, BENADRYL, COMPAZINE, TORADOL and MgSO4 with min. relief. Pt. with LE weakness and 1+ reflexes. LE sensation was intact. Neurology consulted - sx  ?ly due to post - LP NA vs GBS. MRI of brain and spine - WNL  Pt. dc/ed home. Pt. cont. to c/o HA, nausea and lower ext. weakness/numbness. Seen in PCP office on 8/22 and 8/27 and numerous phone calls to office. Pt. seen by neurology and started on gabapentin 300 mg tid and written to have OT/PT 2x/week. Pt.'s sx are persistent - she will attend school in a wheelchair. Pt. with hx of dermoid cyst as infant behind Rt. eye and has a fistula leading out of orbit - followed with yearly CT scans of head by Neurosurgery. Hx of orbital abscess. Last head CT (12/15) - WNL. Hx of 2 concussions in 2014 with subsequent post concussive HA's that gradually resolved.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Pyrexia, Vision blurred, Visual impairment, Weight decreased
Clinical narrative: Pt. received TRUMENBA 8/9/16 at 10 AM and dev. fever at 4pm and severe HA tx'ed with ibu/TYL. Pt. c/o arm swelling around injection site, eye pain, and left-sided numbness extending to her teeth. Pt. also c/o nausea. No V/D. HA cont. to worsen but fever resolved after 48 hrs. Pt. presented to ER for eval. on  8/11 PM. Pt. c/o HA, fever (T max 102 x 2 days), and photophobia/phonophobia/blurry vision. Started ALLEGRA. No hx of rash. No tick exposure. In ER, pt. underwent LP-CSF-4 WBC/4 nucleated cells/RBC 6/nl. glucose/nl. protein/neg. Gram stain. Nl. CBC -  WBC 7.9, hemoglobin 12.8, hematocrit 39, platelet 178. Nl. CMP. Pt. dc'ed home on doxy 100 bid x 14 days and ZOFRAN prn. Pt. returned to ER on 8/14 with persistent sx and dev. of numbness/tingling in legs along with LE weakness. She received non contrast CT of head - WNL, Nl. CBC, BMP, and neg Monospot. She was given migraine "cocktail" of -IVF, BENADRYL, COMPAZINE, TORADOL and MgSO4 with min. relief. Pt. with LE weakness and 1+ reflexes. LE sensation was intact. Neurology consulted - sx  ?ly due to post - LP NA vs GBS. MRI of brain and spine - WNL  Pt. dc/ed home. Pt. cont. to c/o HA, nausea and lower ext. weakness/numbness. Seen in PCP office on 8/22 and 8/27 and numerous phone calls to office. Pt. seen by neurology and started on gabapentin 300 mg tid and written to have OT/PT 2x/week. Pt.'s sx are persistent - she will attend school in a wheelchair. Pt. with hx of dermoid cyst as infant behind Rt. eye and has a fistula leading out of orbit - followed with yearly CT scans of head by Neurosurgery. Hx of orbital abscess. Last head CT (12/15) - WNL. Hx of 2 concussions in 2014 with subsequent post concussive HA's that gradually resolved.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Electromyogram, Lumbar puncture
Clinical narrative: Pt. received TRUMENBA 8/9/16 at 10 AM and dev. fever at 4pm and severe HA tx'ed with ibu/TYL. Pt. c/o arm swelling around injection site, eye pain, and left-sided numbness extending to her teeth. Pt. also c/o nausea. No V/D. HA cont. to worsen but fever resolved after 48 hrs. Pt. presented to ER for eval. on  8/11 PM. Pt. c/o HA, fever (T max 102 x 2 days), and photophobia/phonophobia/blurry vision. Started ALLEGRA. No hx of rash. No tick exposure. In ER, pt. underwent LP-CSF-4 WBC/4 nucleated cells/RBC 6/nl. glucose/nl. protein/neg. Gram stain. Nl. CBC -  WBC 7.9, hemoglobin 12.8, hematocrit 39, platelet 178. Nl. CMP. Pt. dc'ed home on doxy 100 bid x 14 days and ZOFRAN prn. Pt. returned to ER on 8/14 with persistent sx and dev. of numbness/tingling in legs along with LE weakness. She received non contrast CT of head - WNL, Nl. CBC, BMP, and neg Monospot. She was given migraine "cocktail" of -IVF, BENADRYL, COMPAZINE, TORADOL and MgSO4 with min. relief. Pt. with LE weakness and 1+ reflexes. LE sensation was intact. Neurology consulted - sx  ?ly due to post - LP NA vs GBS. MRI of brain and spine - WNL  Pt. dc/ed home. Pt. cont. to c/o HA, nausea and lower ext. weakness/numbness. Seen in PCP office on 8/22 and 8/27 and numerous phone calls to office. Pt. seen by neurology and started on gabapentin 300 mg tid and written to have OT/PT 2x/week. Pt.'s sx are persistent - she will attend school in a wheelchair. Pt. with hx of dermoid cyst as infant behind Rt. eye and has a fistula leading out of orbit - followed with yearly CT scans of head by Neurosurgery. Hx of orbital abscess. Last head CT (12/15) - WNL. Hx of 2 concussions in 2014 with subsequent post concussive HA's that gradually resolved.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MENB, MENB
Symptoms: Migraine, Nuclear magnetic resonance imaging, Paraesthesia, Scan with contrast, Vision blurred
Clinical narrative: Pt. received TRUMENBA 8/9/16 at 10 AM and dev. fever at 4pm and severe HA tx'ed with ibu/TYL. Pt. c/o arm swelling around injection site, eye pain, and left-sided numbness extending to her teeth. Pt. also c/o nausea. No V/D. HA cont. to worsen but fever resolved after 48 hrs. Pt. presented to ER for eval. on  8/11 PM. Pt. c/o HA, fever (T max 102 x 2 days), and photophobia/phonophobia/blurry vision. Started ALLEGRA. No hx of rash. No tick exposure. In ER, pt. underwent LP-CSF-4 WBC/4 nucleated cells/RBC 6/nl. glucose/nl. protein/neg. Gram stain. Nl. CBC -  WBC 7.9, hemoglobin 12.8, hematocrit 39, platelet 178. Nl. CMP. Pt. dc'ed home on doxy 100 bid x 14 days and ZOFRAN prn. Pt. returned to ER on 8/14 with persistent sx and dev. of numbness/tingling in legs along with LE weakness. She received non contrast CT of head - WNL, Nl. CBC, BMP, and neg Monospot. She was given migraine "cocktail" of -IVF, BENADRYL, COMPAZINE, TORADOL and MgSO4 with min. relief. Pt. with LE weakness and 1+ reflexes. LE sensation was intact. Neurology consulted - sx  ?ly due to post - LP NA vs GBS. MRI of brain and spine - WNL  Pt. dc/ed home. Pt. cont. to c/o HA, nausea and lower ext. weakness/numbness. Seen in PCP office on 8/22 and 8/27 and numerous phone calls to office. Pt. seen by neurology and started on gabapentin 300 mg tid and written to have OT/PT 2x/week. Pt.'s sx are persistent - she will attend school in a wheelchair. Pt. with hx of dermoid cyst as infant behind Rt. eye and has a fistula leading out of orbit - followed with yearly CT scans of head by Neurosurgery. Hx of orbital abscess. Last head CT (12/15) - WNL. Hx of 2 concussions in 2014 with subsequent post concussive HA's that gradually resolved.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown). On 05-MAR-2012, the patient received improperly stored (Oka/Merck) VARIVAX dose 2, from lot # 669842/0931AA, expiry date 13-JUN-2013 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (also reported as "medical assistant") refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX injection (dose, lot #, expiry date, route of administration and anatomical location were not specified). No adverse reactions were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 06-JAN-2009, the patient received improperly stored VARIVAX dose 2, from lot # 661445/0525X, expiry date 27-MAR-2010 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 29-JUL-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route were unknown, lot # L044694, expiration date 04-FEB-2018), which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On 03-AUG-2016 the patients were vaccinated with improperly stored GARDASIL 9 lot # L038503/expiration date- 18-DEC-2017, lot # L026602/expiration date- 19-OCT-2017. No adverse event was reported. No concomitant medication was reported. The call was because of digital data logger. Temperature/Time frame: 8.9C for 1 hour and 1 minute and previous excursion was 10.4C for 6 hours 18 minutes. The outcome of event was unknown. No PQC (product quality complaint was involved). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients. Their medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patients were administered improperly stored PROQUAD (strength, dose, frequency and route were unknown; lot number and expiration were L051098/17-JUN-2017, M006102/01-AUG-2017. No adverse effects reported. The temperature excursion was 6.8 degree Fahrenheit for 45 minutes. There was no previous temperature excursion. This report was for data logger. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (dose, lot #, expiry date, anatomical location and route of administration were not reported). No adverse reactions were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 25-JUL-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route were unknown, lot # L040458, expiration date 04-FEB-2018), which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 12-JUL-2010, the patient received improperly stored VARIVAX dose 2, from lot # 666851/0280Z, expiry date 12-FEB-2012 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated the vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL injection (dose, lot #, expiry date, anatomical location and route of administration were not reported). No adverse reactions were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 28-JUL-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route were unknown, lot # L044694, expiratory date 04-FEB-2018), which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 05-JUN-2012, the patient received improperly stored VARIVAX dose 2, from lot # 671861/1907AA, expiry date 05-DEC-2013 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G decreased
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient. The patient's concurrent conditions, medical histories and concomitant therapies were unknown. On 14-OCT-1995, the patient was vaccinated with the first dose of VARIVAX injection (lot #, expiration date, strength, dose, frequency and route unknown). On 01-SEP-2010 the patient was vaccinated with the second dose of VARIVAX injection (lot # 668080/0721Z, expiration date 14-MAY-2012; strength, dose, frequency and route unknown). On 29-MAY-2013, the patient was vaccinated with the third dose of VARIVAX injection (lot # H018526, expiration date 09-OCT-2014; strength, dose, frequency and route unknown). On 10-AUG-2016, the patient had varicella titers drawn for an unspecified reason and the result of the varicella titers showed the "patient's immunoglobulin G (IgG) level was down". The outcome of immunoglobulin G decreased was unknown. No product quality complaint (PQC) was involved. The causal relationship between immunoglobulin G decreased and VARIVAX was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a certified nurse practitioner refers to a 16 year old non-pregnant female patient. The patient's pertinent medical history included anxiety, depression, obsessive-compulsive disorder and irritable bowel syndrome. The patient had no medication allergies. On 11-AUG-2016, the patient was vaccinated with GARDASIL 9 injection, subcutaneously, 0.5 ml (dose, lot #, expiry date and anatomical location were not reported). Concomitant therapies included ABILIFY, clonazepam, LAMICTAL and ZOLOFT. On 12-AUG-2016, after receiving GARDASIL 9, the patient presented with rash and sought medical attention. No lab diagnostic studies were performed. The patient received treatment for the adverse event (details were not specified). Product quality complaint (PQC) was not involved. The outcome of the event was reported as not recovered. The reporter did not provide the causality assessment between the event and GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 29-JUL-2011 the patient was vaccinated with improperly stored VARIVAX lot # 669223/1564Z dose number 2. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown). On 03-MAY-2012, the patient received improperly stored (Oka/Merck) VARIVAX dose 2, from lot # 1273AA (dose, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant and refers to an unknown number of unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions or allergies were not reported. In approximately 2016, reported as on unknown dates starting on or after 11-JUL-2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L042259, expiration date: 18-AUG-2018 and lot# M007762, expiration date: 07-DEC-2018 (dose and route of administration were not reported). Administered doses of vaccine experienced temperature excursion of 48 degree Fahrenheit for 30 minutes. There was no previous temperature excursion. No adverse effects were reported. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Muscle disorder
Clinical narrative: This spontaneous report was received on 18-JUL-2016 from a physician via a company representative, referring to the daughter (age not reported) of a nurse who on an unknown date was vaccinated with GARDASIL (dose and site of vaccination not reported). The female patient experienced like a "divot" on the muscle for "over a year" on area where shot was given. The patient had to carry something very heavy to use that muscle and helped out with strengthening the muscle. No other information was provided for documentation. The patient sought medical attention (not further specified). It was unknown if the patient received treatment for the event. Patient status was reported as recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 10-MAR-2015, the patient received improperly stored VARIVAX dose 2, from lot # K007982 (dose, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. On 01-JUN-2012, the patient was vaccinated with improperly stored dose of VARIVAX dose 1, lot#: 671861/1907AA. On 29-JUN-2012, the patient was vaccinated with the second improperly stored dose of VARIVAX, lot#: 671861/1907AA. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician via a company representative reporting to a patient of unknown gender and age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX injection, 19400 PFU)plaque-forming-units)(lot number, expiration date, dose were not provided), subcutaneous in the arm. There were no concomitant medications reported. The physician stated that the patient had reaction after receiving the ZOSTAVAX. He reported that his patient called to say that the vaccinated arm was red and swollen (Peripheral swelling), (Erythema). The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose route and frequency unknown. On 16-MAR-2015, the patient was vaccinated with improperly stored VARIVAX lot # K007982 dose number 2. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Vaccines given by CMA at approximately 4:40 pm. Physician went to speak with patient's mother roughly five minutes later; physician noticed redness, swelling, hives at site of varicella vaccine. Watched in office x20 minutes then gave 3.75mL infants acetaminophen.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 17-NOV-2011, patient received improperly stored VARIVAX dose 1, from batch/lot # 669601/0138AA ( expiry date, dose units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received form a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 02-JUN-2010, patient received improperly stored VARIVAX dose 2, from batch/lot # 665413/1128Y (expiry date, dose units, route and anatomical location were not specified). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On 18-JUL-2012, the patient was vaccinated with the first dose of improperly stored VARIVAX lot # 671861/1907AA. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 02-AUG-2013, patient received improperly stored VARIVAX dose 2, from batch/lot # H018451 (expiry date, dose units, route and anatomical location were not specified). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 07-JUN-2010, patient received improperly stored VARIVAX dose 2, from batch/lot #665413/1128Y (expiry date, dose units, route and anatomical location were not specified) (incorrect product storage). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 60 year old female patient. The patient had no pertinent medical history. Her concurrent conditions and concomitant medications were not reported. On 26-JUL-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, intramuscularly in the left arm, lot # L035687 and expiry date: 16-FEB-2017 (also reported as "smoker"). Then, on the same day, the patient received ZOSTAVAX on the opposite arm (dosing details not reported). Subsequently, 2 or 3 days after vaccination, approximately on 28-JUL-2016, the patient developed red spot on an unspecified location on her left arm. The did not receive any treatment and no lab diagnostic tests were performed. The outcome of the event was reported as not recovered. The reporter did not assess the relatedness between the event and the vaccines. This case is cross reference with WAES1608USA000865. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Erythema, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 60 year old female patient. The patient had no pertinent medical history. Her concurrent conditions and concomitant medications were not reported. On 26-JUL-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, intramuscularly in the left arm, lot # L035687 and expiry date: 16-FEB-2017 (also reported as "smoker"). Then, on the same day, the patient received ZOSTAVAX on the opposite arm (dosing details not reported). Subsequently, 2 or 3 days after vaccination, approximately on 28-JUL-2016, the patient developed red spot on an unspecified location on her left arm. The did not receive any treatment and no lab diagnostic tests were performed. The outcome of the event was reported as not recovered. The reporter did not assess the relatedness between the event and the vaccines. This case is cross reference with WAES1608USA000865. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 11-year-old male patient who received MENVEO (batch number M15125, expiry date 31st May 2017). Concomitant products included BOOSTRIX. On 8th August 2016, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On 9th August 2016, 1 days after receiving MENVEO, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were not recovered/not resolved. The reporter considered the injection site swelling and injection site pain to be almost certainly related to MENVEO. Additional details were provided as follows: This case was not previously reported to anyone. This case was reported by a physician's assistant. On 8th August 2016, the patient received BOOSTRIX (batch number K2D2T, expiry date 8th December 2018) in left arm intramuscularly. The patient experienced swelling (8 cm) administration of MENVEO in right arm.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Client received a Tdap injection to right deltoid on 8/19//2016 at this clinic by this nurse. Client revisited clinic with this nurse for an unrelated matter on 8/22/2016. Clients' mom requested this RN look at the clients' right arm where the Tdap injection was administered on 8/19/2016. RN lifted clients' right shirt sleeve to find his right upper arm and the Tdap injection site to be red, swollen and warm to the touch. Mom sated she noticed the right arm was very large and swollen on Saturday evening and she applied cold packs to the site. RN asked mom if she had taken client to his doctor for an evaluation. Mom stated she had not done so. RN encouraged mom to take client to their doctor to have his right arm looked at. RN told mom that the clients arm may need medical treatment. RN reviewed the Tdap VIS with mom. Encouraged mom to call the National Vaccine Injury Program. RN informed mom that a VAERS report would be filled out for the event. Mom left clinic stating she was taking the client to the doctors prior to going to school.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 11-year-old male patient who received MENVEO (batch number M15125, expiry date 31st May 2017). On 15th August 2016, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On 16th August 2016, 1 days after receiving MENVEO, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were not recovered/not resolved. The reporter considered the injection site swelling and injection site pain to be almost certainly related to MENVEO. Additional details were provided as follows: This case was not previously reported to anyone. This case was reported by a physician assistant. The patient received a dose of MENVEO in right arm and experienced swelling (8 centimetres) and pain at injection site.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Loss of consciousness, Malaise, Syncope
Clinical narrative: Injection administered at 1000. At 1002 patient reported not feeling well. 1003 patient fainted-we lowered her into a chair. A cold cloth was applied to her forehead. Pt. was unconscious, but breathing and had a pulse for 3 minutes. Pt. responded verbally after 3 minutes. At 1010 pt. walked to an exam room, 1045 pt. left was recovered.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 16-APR-2012, patient received improperly stored VARIVAX dose 2, from batch/lot # 669842/0931AA (expiry date, dose units, route and anatomical location were not specified). No adverse effects were reported. the reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Had vaccine 8/17/16 and developed hives after swimming 3 days later on 8/20/16 and again after swimming on 8/21/16. No further sx since that time.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified patients of unknown demographics. On an unknown dates, the patients were administered with improperly stored VARIVAX (strength unspecified) lot # L024253 with exp. date: 01-JUL-2017; lot # L024256 with exp. date: 01-JUL-2017; lot# L001328 with exp. date: 13-JAN-2017 and lot # L016123 with exp. date 06-MAY-2017. No adverse effects were reported. The vaccine was exposed to temperature of 10.47F for a time frame of 62 hours and 30 minutes. No previous temperature excursion involved. No data logger involved. No product quality complaint involved. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 24-MAY-2010, patient received improperly stored VARIVAX dose 2, from batch/lot #665413/1128Y (expiry date, dose units, route and anatomical location were not specified) (incorrect product storage). Concomitant medications were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 14-JUL-2016, the patient was vaccinated with the first dose of ZOSTAVAX (subcutaneously, lot # L046896, expiry date: 23-FEB-2017). On 01-AUG-2016, (also reported as today), the patient was inadvertently administered a second dose of ZOSTAVAX (subcutaneously. lot # L046896, expiry date: 23-FEB-2017). Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding to multiple unspecified patients of unknown age and gender. No concurrent conditions or pertinent medical history were reported. The registered nurse reported that on unspecified dates between 01-AUG-2016 and 23-AUG-2016, multiple unspecified patients received improperly stored doses of PROQUAD lot number M007961, expiration date 15-AUG-2017, lot number M002056, expiration date 11-JUL-2017, lot number M014304, expiration date 22-SEP-2017, lot number L051100, expiration date 17-AUG-2017 and lot number M007965, expiration date 15-AUG-2017, (dose, frequency and route not reported). No adverse effects were reported. The registered nurse confirmed that the excursion temperature was 8F for a time frame of 552 hours. The temperature went back in range and there were no previous excursions. It was unknown if the report was part a data logger, and no product quality complaint was involved. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose route and frequency unknown. On 02-FEB-2012, the patient was vaccinated with improperly stored dose of VARIVAX lot # 669842/0931AA dose number 2. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose VARIVAX, dose route and frequency unknown. On 31-MAY-2007 the patient was vaccinated with improperly stored VARIVAX lot # 656078/0169U dose number 2. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.