chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (dose, frequency, route of administration and indication were not reported, lot number# L007560 expiration date: 18-JUN-2017, K006960 expiration date: 19-FEB-2017, K007264 expiration date: 02-MAR-2017, K011562 expiration date: 08-APR-2017, K023432 expiration date: 18-JUN-2016). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021058, is an initial spontaneous report received from a pharmacist on 16 Oct 2015. This report refers to an 11 year old male patient. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173988) intramuscularly at a dose of 0.5 ml on 14 Oct 2015. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Age: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021219, is an initial spontaneous report from a health care professional received on 19 Oct 2015. This report refers to a 14 years old female patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173991) at a dose of 0.5 ml intramuscularly on 15 Oct 2015. The case was assessed as non-serious. No adverse event was reported.
Age: 38.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019585 is an initial spontaneous report from a health care professional received on 30 Sep 2015. This report refers to a 38 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX, (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. It was reported that FLUCELVAX as kept at room temperature for 24 hours before administering the patient. No adverse event was reported following this maladministration (incorrect storage of drug).
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019571, is an initial spontaneous report received from a health care professional (HCP) on 30 Sep 2015. This report refers to a 57 year old female patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. The HCP reported that the FLUCELVAX which was stored at room temperature for 24 hours was administered to employees. No adverse event was reported following the medication error (incorrect storage of drug).
Age: 5.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US023383, is an initial spontaneous report received from a Healthcare Professional on 09 Nov 2015. This report refers to a 5 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX, (batch number: 173987) intramuscularly at a dose of 0.5 ml on 08 Nov 2015. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US023876 is an initial spontaneous report received from a health care professional on 13 Nov 2015. This report refers to a 13 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173989) intramuscularly at a dose of 0.5 ml on 11 Nov 2015. No adverse event was reported following this medication error (drug administered to patient of inappropriate age).
Age: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US023881 is an initial spontaneous report received from a health care professional on 13 Nov 2015. This report refers to a 13 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173989) intramuscularly at a dose of 0.5 ml on 11 Nov 2015. No adverse event was reported following this medication error (drug administered to patient of inappropriate age).
Age: 28.0
Sex: F
Vaccine: FLUC3
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: Case number PHEH2015US024141, is an initial spontaneous report received from a patient who is also a nurse on 16 Nov 2015. This report refers to a 28-year-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174272) intramuscularly on 11 Nov 2015. On 13 Nov 2015, the patient started to feel severe nausea, abdominal pain and diarrhea. The patient reported that, she had issues each year in getting the Flu shot. Outcome of the events was reported as condition unchanged. Events were reported as non serious and causality was not reported.
Age: 53.0
Sex: F
Vaccine: FLUC3
Symptoms: Swelling, Urticaria
Clinical narrative: Case number PHHY2015US134239 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 572838) on 05 Oct 2015. This report refers to a 53 year female patient. Her current conditions included rheumatoid arthritis (RA) and celiac disease. Her concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: not reported) on an unknown date. On an unspecified date after vaccination, the patient experienced hives and swelling. The events outcome, seriousness and causality were not reported. No further information was provided.
Age: 44.0
Sex: M
Vaccine: FLUC3
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: Case number PHEH2015US018589, is an initial spontaneous report from a nurse received on 18 Sep 2015. This report refers to a 44 years old male patient. Concurrent condition included diabetes mellitus. Concomitant medications were not reported. Preivous vaccinations were well tolerated. The patient was vaccinated with FLUCELVAX, (batch number 173839) at a dose of 0.5 ml intramuscularly into right deltoid on 09 Sep 2015. On 10 Sep 2015 the patient experienced malaise, fever and headache. The events recovered on 15 Sep 2015. Seriousness and causality of the events was not reported.
Sex: U
Vaccine: FLUC3
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Case number PHEH2015US018642 is an initial spontaneous report from a pharmacist received on 17 Sep 2015. This report refers to a patient of an unknown age and gender. The patient was allergic to latex. The patient was accidentally vaccinated with FLUCELVAX, (batch number: 174269) intramuscularly on 17 Sep 2015. No adverse event reported following this medication error (contraindication to vaccination).
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019560, is an initial spontaneous report received from a health care professional (HCP) on 30 Sep 2015. This report refers to a 47 year old female patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. The HCP reported that the FLUCELVAX which was stored at room temperature for 24 hours was administered to employees. No adverse event was reported following the medication error (incorrect storage of drug).
Age: 56.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US01956, is an initial spontaneous report received from a healthcare professional on 30 Sep 2015. This report refers to a 56 year old female patient. Historical conditions and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. It was reported that, before administration, the FLUCELVAX was stored at room temperature for 24 hours. No adverse event was reported following this medication error.
Age: 26.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019582, is an initial spontaneous report received from a healthcare professional on 30 Sep 2015. This reports refers to a 26 year old female patient. Historical condition and concomitant medication were unknown. The patient was vaccinated with FLUCELVAX, (batch number: 173539) intramuscular at a dose of 0.5 ml on 23 Sep 2015. It was reported that the FLUCELVAX vaccine was stored at room temperature for 24 hours and then it was administered to the patient. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided.
Age: 55.0
Sex: M
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019563, is an initial spontaneous report received from a healthcare professional on 30 Sep 2015. This report refers to a 55 year old male patient. Historical condition and concomitant medication were unknown. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. It was reported that the FLUCELVAX vaccine was stored at room temperature for 24 hours and then it was administered to the patient. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided.
Age: 43.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019584, is an initial spontaneous report from a healthcare professional received on 30 Sep 2015. This report refers to a 43 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX, (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. On the same day it was found that FLUCELVAX was kept at room temperature for 24 hours and was administered to the patient. No adverse event was reported following this maladministration (incorrect storage of drug).
Age: 58.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019586 is an initial spontaneous report from a health care professional received on 30 Sep 2015. This report refers to a 58 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX, (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. It was reported that FLUCELVAX was kept at room temperature for 24 hours before administering the patient. No adverse event was reported following this maladministration (incorrect storage of drug).
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019567 is an initial spontaneous report from a health care professional received on 30 Sep 2015. This report refers to a 47 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. It was reported that FLUCELVAX was kept at room temperature for 24 hours before administering the patient. No adverse event was reported following this maladministration (incorrect storage of drug).
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019568, is an initial spontaneous report from a health care professional received on 30 Sep 2015. This report refers to a 47 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX, (batch number: 173539) at a dose of 0.5 ml intramuscularly on 23 Sep 2015. It was reported FLUCELVAX was at room temperature for 24 hours before administration. No adverse event was reported.
Age: 48.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019589, is an initial spontaneous report from a health care professional received on 30 Sep 2015. This report refers to a 48 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX, (batch number: 173539) at a dose of 0.5 ml intramuscularly on 23 Sep 2015. It was reported FLUCELVAX was at room temperature for 24 hours before administration. No adverse event was reported.
Age: 29.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019570, is an initial spontaneous report received from a health care professional (HCP) on 30 Sep 2015. This report refers to a 29 year old female patient. Historical conditions and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. The HCP reported that the FLUCELVAX which was stored at room temperature for 24 hours was administered to employees. No adverse event was reported following the medication error.
Age: 5.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021220, is an initial spontaneous report from a health care professional received on 19 Oct 2015. This report refers to a 5 years old male patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173991) at a dose of 0.5 ml intramuscularly on 15 Oct 2015. The case was assessed as non-serious. No adverse event was reported.
Age: 2.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021222, is an initial spontaneous report from a health care professional received on 19 Oct 2015. This report refers to a 2 years old male patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 1733991) at a dose of 0.5 ml intramuscularly on 15 Oct 2015. The case was assessed as non-serious. No adverse event was reported.
Age: 8.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021475, is an initial spontaneous report from a pharmacist received on 21 Oct 2015. This report refers to an 8-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUCELVAX, (batch number: 173989) intramuscularly on 20 Oct 2015. No adverse event was reported.
Sex: F
Vaccine: FLUC3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Case number PHEH2015US023187, is a spontaneous report initially received from physician on 06 Nov 2015 and follow up from Quality Assurance Department (QA, reference number: 1008467) on 10 Nov 2015 (combined report). This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX (batch number: 173538) intramuscularly on 05 Nov 2015. It was reported that during vaccination of the patient leak happened from where the needle was attached to the syringe. The case was assessed as non-serious. No adverse event was reported.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 17-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # J013394 with expiration date 25-AUG-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: No adverse event, Syringe issue
Clinical narrative: Case number PHEH2015US023189 is an initial spontaneous report received from physician on 06 Nov 2015 and Quality Assurance Department (QA, reference number: 1008487) on 10 Nov 2015 (combined report). This report refers to a 52 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX (batch number: 173538) intramuscularly on an unknown date within the last week. It was reported that during vaccination there was leakage of vaccine from where the needle was attached to the syringe. The case was assessed as non-serious. No adverse event was reported.
Age: 5.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US023382, is an initial spontaneous report received from a healthcare professional on 09 Nov 2015. This report refers to a 5 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173987) intramuscularly at a dose of 0.5 ml on 08 Nov 2015. No adverse event was reported following this maladministration.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 11-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # J013555, expiry date 02-MAY-2015 (dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021213, is an initial spontaneous report received from a health care professional on 19 Oct 2015. This report refers to a 9 year old female patient. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173991) intramuscularly at a dose of 0.5 ml on 15 Oct 2015. The case was reported as non-serious. No adverse event was reported following this maladministration.
Age: 8.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021218, is an initial spontaneous report received from a health care professional on 19 Oct 2015. This report refers to an 8 year old female patient. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX, (batch number: 173991) intramuscularly at a dose of 0.5 ml on 15 Oct 2015. The case was reported as non-serious. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).
Age: 1.52
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021059, is an initial spontaneous report received from a pharmacist on 16 Oct 2015. This report refers to an 18 month old female patient. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173988) intramuscularly at a dose of 0.5 ml on 14 Oct 2015. No adverse event was reported following this maladministration.
Age: 3.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US021049, is an initial spontaneous report received from a pharmacist on 16 Oct 2015. This report refers to a 3 years old male patient. Medical history and concomitant medication were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173988) intramuscularly at a dose of 0.5 ml o 14 Oct 2015. The case was reported as non-serious. No adverse event was reported following the maladministration.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 13 year old male patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 25-AUG-2015 at 04:14 pm, the patient was vaccinated with the second dose (reported as #1 given elsewhere) of VARIVAX injection, lot # L010145, subcutaneously (dose and expiration date were not provided) that was improperly stored. Other suspect therapies included MENACTRA, Hep A vaccine (unspecified) (manufacturer reported as GlaxoSmithKline) and Tdap (manufacturer reported as Sanofi) (all administered on the same day and time, intramuscularly). This is one of the several reports from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated orally with improperly stored ROTATEQ (dose, frequency and indication were not reported, lot number# (K022995 expiration date: 22-JUL-2016, L008057 expiration date: 01-FEB-2016, K004432 expiration date: 27-JAN-2016, K023537 expiration date: 22-JUN-2016, L04453 expiration date: 27-MAY-2016, L008054 expiration date: 30-NOV-2016). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX, (lot #L031273, expiration date: 19-NOV-2016), (dose and frequency were not provided). Concomitant therapies were not reported. On 12-AUG-2015, the pharmacist noted that the vaccine administered was improperly stored. No adverse effect was reported. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Seizure
Clinical narrative: Seizure (pt has hx of seizures but have been well-controlled for years until this occurrence).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Abasia, Balance disorder, Cough, Gait disturbance, Hypertonia
Clinical narrative: 2 weeks after vaccines given - muscular weakness, distal hypertonicity of limbs, suspected tetanus. The patient presents with bilateral, lower extremity, altered gait and altered coordination. The onset was 1 weeks ago. The course/duration of symptoms is constant and worsening. The character of symptoms is weakness, off-balance and increased muscle tone/contracture. The degree at present is moderate. Risk factors consist of none. Prior episodes: none. Therapy today: none. Associated symptoms: none. Baseline status: ambulatory. Patient sent to the ED by PCP after evaluating patient this AM and then speaking with pediatric neurologist Dr. Patient presents with gait abnormality, LE stiffness for approximately 1-2 weeks, which has gotten progressively worse. Parents noted that they thought they observed abnormalities last week, but weren't fully aware of the situation until they received a call from patient's teacher who had observed his altered gait on the playground at school. Parents stated that patient was able to engage in physical activity throughout the week, but they grew particularly concerned yesterday. After a physically active day at a farm yesterday, patient was unable to walk after his evening bath, and was observed crawling/dragging his body. Patient is not in any pain, and does not note any discomfort. When asked where he feels weak, he points to his achilles tendon. Mom also notes that she has heard an occasional cough, which patient states his sister gave to him. Mom states that patient is up to date on his vaccinations, where he received his 3 shots at the end of September.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Hyporeflexia, Muscle contracture, Muscular weakness, Musculoskeletal stiffness, Tendon disorder
Clinical narrative: 2 weeks after vaccines given - muscular weakness, distal hypertonicity of limbs, suspected tetanus. The patient presents with bilateral, lower extremity, altered gait and altered coordination. The onset was 1 weeks ago. The course/duration of symptoms is constant and worsening. The character of symptoms is weakness, off-balance and increased muscle tone/contracture. The degree at present is moderate. Risk factors consist of none. Prior episodes: none. Therapy today: none. Associated symptoms: none. Baseline status: ambulatory. Patient sent to the ED by PCP after evaluating patient this AM and then speaking with pediatric neurologist Dr. Patient presents with gait abnormality, LE stiffness for approximately 1-2 weeks, which has gotten progressively worse. Parents noted that they thought they observed abnormalities last week, but weren't fully aware of the situation until they received a call from patient's teacher who had observed his altered gait on the playground at school. Parents stated that patient was able to engage in physical activity throughout the week, but they grew particularly concerned yesterday. After a physically active day at a farm yesterday, patient was unable to walk after his evening bath, and was observed crawling/dragging his body. Patient is not in any pain, and does not note any discomfort. When asked where he feels weak, he points to his achilles tendon. Mom also notes that she has heard an occasional cough, which patient states his sister gave to him. Mom states that patient is up to date on his vaccinations, where he received his 3 shots at the end of September.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Tetanus
Clinical narrative: 2 weeks after vaccines given - muscular weakness, distal hypertonicity of limbs, suspected tetanus. The patient presents with bilateral, lower extremity, altered gait and altered coordination. The onset was 1 weeks ago. The course/duration of symptoms is constant and worsening. The character of symptoms is weakness, off-balance and increased muscle tone/contracture. The degree at present is moderate. Risk factors consist of none. Prior episodes: none. Therapy today: none. Associated symptoms: none. Baseline status: ambulatory. Patient sent to the ED by PCP after evaluating patient this AM and then speaking with pediatric neurologist Dr. Patient presents with gait abnormality, LE stiffness for approximately 1-2 weeks, which has gotten progressively worse. Parents noted that they thought they observed abnormalities last week, but weren't fully aware of the situation until they received a call from patient's teacher who had observed his altered gait on the playground at school. Parents stated that patient was able to engage in physical activity throughout the week, but they grew particularly concerned yesterday. After a physically active day at a farm yesterday, patient was unable to walk after his evening bath, and was observed crawling/dragging his body. Patient is not in any pain, and does not note any discomfort. When asked where he feels weak, he points to his achilles tendon. Mom also notes that she has heard an occasional cough, which patient states his sister gave to him. Mom states that patient is up to date on his vaccinations, where he received his 3 shots at the end of September.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Abasia, Abnormal behaviour, Blood albumin normal, Blood creatine phosphokinase increased, Blood gases abnormal
Clinical narrative: 2 weeks after vaccines given - muscular weakness, distal hypertonicity of limbs, suspected tetanus. The patient presents with bilateral, lower extremity, altered gait and altered coordination. The onset was 1 weeks ago. The course/duration of symptoms is constant and worsening. The character of symptoms is weakness, off-balance and increased muscle tone/contracture. The degree at present is moderate. Risk factors consist of none. Prior episodes: none. Therapy today: none. Associated symptoms: none. Baseline status: ambulatory. Patient sent to the ED by PCP after evaluating patient this AM and then speaking with pediatric neurologist Dr. Patient presents with gait abnormality, LE stiffness for approximately 1-2 weeks, which has gotten progressively worse. Parents noted that they thought they observed abnormalities last week, but weren't fully aware of the situation until they received a call from patient's teacher who had observed his altered gait on the playground at school. Parents stated that patient was able to engage in physical activity throughout the week, but they grew particularly concerned yesterday. After a physically active day at a farm yesterday, patient was unable to walk after his evening bath, and was observed crawling/dragging his body. Patient is not in any pain, and does not note any discomfort. When asked where he feels weak, he points to his achilles tendon. Mom also notes that she has heard an occasional cough, which patient states his sister gave to him. Mom states that patient is up to date on his vaccinations, where he received his 3 shots at the end of September.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Blood lactic acid increased, Blood thyroid stimulating hormone normal, Cytogenetic analysis normal, Demyelination, Differential white blood cell count normal
Clinical narrative: 2 weeks after vaccines given - muscular weakness, distal hypertonicity of limbs, suspected tetanus. The patient presents with bilateral, lower extremity, altered gait and altered coordination. The onset was 1 weeks ago. The course/duration of symptoms is constant and worsening. The character of symptoms is weakness, off-balance and increased muscle tone/contracture. The degree at present is moderate. Risk factors consist of none. Prior episodes: none. Therapy today: none. Associated symptoms: none. Baseline status: ambulatory. Patient sent to the ED by PCP after evaluating patient this AM and then speaking with pediatric neurologist Dr. Patient presents with gait abnormality, LE stiffness for approximately 1-2 weeks, which has gotten progressively worse. Parents noted that they thought they observed abnormalities last week, but weren't fully aware of the situation until they received a call from patient's teacher who had observed his altered gait on the playground at school. Parents stated that patient was able to engage in physical activity throughout the week, but they grew particularly concerned yesterday. After a physically active day at a farm yesterday, patient was unable to walk after his evening bath, and was observed crawling/dragging his body. Patient is not in any pain, and does not note any discomfort. When asked where he feels weak, he points to his achilles tendon. Mom also notes that she has heard an occasional cough, which patient states his sister gave to him. Mom states that patient is up to date on his vaccinations, where he received his 3 shots at the end of September.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Electroencephalogram normal, Electromyogram abnormal, Fall, Fatigue, Gait disturbance
Clinical narrative: 2 weeks after vaccines given - muscular weakness, distal hypertonicity of limbs, suspected tetanus. The patient presents with bilateral, lower extremity, altered gait and altered coordination. The onset was 1 weeks ago. The course/duration of symptoms is constant and worsening. The character of symptoms is weakness, off-balance and increased muscle tone/contracture. The degree at present is moderate. Risk factors consist of none. Prior episodes: none. Therapy today: none. Associated symptoms: none. Baseline status: ambulatory. Patient sent to the ED by PCP after evaluating patient this AM and then speaking with pediatric neurologist Dr. Patient presents with gait abnormality, LE stiffness for approximately 1-2 weeks, which has gotten progressively worse. Parents noted that they thought they observed abnormalities last week, but weren't fully aware of the situation until they received a call from patient's teacher who had observed his altered gait on the playground at school. Parents stated that patient was able to engage in physical activity throughout the week, but they grew particularly concerned yesterday. After a physically active day at a farm yesterday, patient was unable to walk after his evening bath, and was observed crawling/dragging his body. Patient is not in any pain, and does not note any discomfort. When asked where he feels weak, he points to his achilles tendon. Mom also notes that she has heard an occasional cough, which patient states his sister gave to him. Mom states that patient is up to date on his vaccinations, where he received his 3 shots at the end of September.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Gastrointestinal examination normal, Haematocrit decreased, Haemoglobin decreased, Hyperhidrosis, Immunology test normal
Clinical narrative: 2 weeks after vaccines given - muscular weakness, distal hypertonicity of limbs, suspected tetanus. The patient presents with bilateral, lower extremity, altered gait and altered coordination. The onset was 1 weeks ago. The course/duration of symptoms is constant and worsening. The character of symptoms is weakness, off-balance and increased muscle tone/contracture. The degree at present is moderate. Risk factors consist of none. Prior episodes: none. Therapy today: none. Associated symptoms: none. Baseline status: ambulatory. Patient sent to the ED by PCP after evaluating patient this AM and then speaking with pediatric neurologist Dr. Patient presents with gait abnormality, LE stiffness for approximately 1-2 weeks, which has gotten progressively worse. Parents noted that they thought they observed abnormalities last week, but weren't fully aware of the situation until they received a call from patient's teacher who had observed his altered gait on the playground at school. Parents stated that patient was able to engage in physical activity throughout the week, but they grew particularly concerned yesterday. After a physically active day at a farm yesterday, patient was unable to walk after his evening bath, and was observed crawling/dragging his body. Patient is not in any pain, and does not note any discomfort. When asked where he feels weak, he points to his achilles tendon. Mom also notes that she has heard an occasional cough, which patient states his sister gave to him. Mom states that patient is up to date on his vaccinations, where he received his 3 shots at the end of September.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Liver function test normal, Lumbar puncture normal, Mobility decreased, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: 2 weeks after vaccines given - muscular weakness, distal hypertonicity of limbs, suspected tetanus. The patient presents with bilateral, lower extremity, altered gait and altered coordination. The onset was 1 weeks ago. The course/duration of symptoms is constant and worsening. The character of symptoms is weakness, off-balance and increased muscle tone/contracture. The degree at present is moderate. Risk factors consist of none. Prior episodes: none. Therapy today: none. Associated symptoms: none. Baseline status: ambulatory. Patient sent to the ED by PCP after evaluating patient this AM and then speaking with pediatric neurologist Dr. Patient presents with gait abnormality, LE stiffness for approximately 1-2 weeks, which has gotten progressively worse. Parents noted that they thought they observed abnormalities last week, but weren't fully aware of the situation until they received a call from patient's teacher who had observed his altered gait on the playground at school. Parents stated that patient was able to engage in physical activity throughout the week, but they grew particularly concerned yesterday. After a physically active day at a farm yesterday, patient was unable to walk after his evening bath, and was observed crawling/dragging his body. Patient is not in any pain, and does not note any discomfort. When asked where he feels weak, he points to his achilles tendon. Mom also notes that she has heard an occasional cough, which patient states his sister gave to him. Mom states that patient is up to date on his vaccinations, where he received his 3 shots at the end of September.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Peripheral sensorimotor neuropathy, Protein total normal, Speech disorder, Toe walking, Toxicologic test normal
Clinical narrative: 2 weeks after vaccines given - muscular weakness, distal hypertonicity of limbs, suspected tetanus. The patient presents with bilateral, lower extremity, altered gait and altered coordination. The onset was 1 weeks ago. The course/duration of symptoms is constant and worsening. The character of symptoms is weakness, off-balance and increased muscle tone/contracture. The degree at present is moderate. Risk factors consist of none. Prior episodes: none. Therapy today: none. Associated symptoms: none. Baseline status: ambulatory. Patient sent to the ED by PCP after evaluating patient this AM and then speaking with pediatric neurologist Dr. Patient presents with gait abnormality, LE stiffness for approximately 1-2 weeks, which has gotten progressively worse. Parents noted that they thought they observed abnormalities last week, but weren't fully aware of the situation until they received a call from patient's teacher who had observed his altered gait on the playground at school. Parents stated that patient was able to engage in physical activity throughout the week, but they grew particularly concerned yesterday. After a physically active day at a farm yesterday, patient was unable to walk after his evening bath, and was observed crawling/dragging his body. Patient is not in any pain, and does not note any discomfort. When asked where he feels weak, he points to his achilles tendon. Mom also notes that she has heard an occasional cough, which patient states his sister gave to him. Mom states that patient is up to date on his vaccinations, where he received his 3 shots at the end of September.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV, DTAPIPV, FLU3, MMRV
Symptoms: Weight bearing difficulty
Clinical narrative: 2 weeks after vaccines given - muscular weakness, distal hypertonicity of limbs, suspected tetanus. The patient presents with bilateral, lower extremity, altered gait and altered coordination. The onset was 1 weeks ago. The course/duration of symptoms is constant and worsening. The character of symptoms is weakness, off-balance and increased muscle tone/contracture. The degree at present is moderate. Risk factors consist of none. Prior episodes: none. Therapy today: none. Associated symptoms: none. Baseline status: ambulatory. Patient sent to the ED by PCP after evaluating patient this AM and then speaking with pediatric neurologist Dr. Patient presents with gait abnormality, LE stiffness for approximately 1-2 weeks, which has gotten progressively worse. Parents noted that they thought they observed abnormalities last week, but weren't fully aware of the situation until they received a call from patient's teacher who had observed his altered gait on the playground at school. Parents stated that patient was able to engage in physical activity throughout the week, but they grew particularly concerned yesterday. After a physically active day at a farm yesterday, patient was unable to walk after his evening bath, and was observed crawling/dragging his body. Patient is not in any pain, and does not note any discomfort. When asked where he feels weak, he points to his achilles tendon. Mom also notes that she has heard an occasional cough, which patient states his sister gave to him. Mom states that patient is up to date on his vaccinations, where he received his 3 shots at the end of September.
Age: 1.2
Sex: F
Vaccine: HEP, HEPA
Symptoms: Body temperature increased, Full blood count, Metabolic function test, Seizure
Clinical narrative: Seizure-generalized, associated with rectal temp 103.2. 28 hours after vaccinations.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 14 year old male patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 25-AUG-2015 at 12:20 p.m., the patient was vaccinated with the second dose (reported as #1 given elsewhere) of VARIVAX injection, lot # L010145, subcutaneously (dose and expiration date were not reported) that was improperly stored. No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected as all correspondence was received.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Lethargy, Pain in extremity
Clinical narrative: This spontaneous report was received from a 65 year old female patient (physician) via a company representative. The patient's pertinent medical history, drug reactions/allergies were not provided. The patient's vaccination history included PNEUMOVAX 23 (self-administered at the age of "44 or 46") and PREVNAR 13 at the age of 64. On approximately 27-NOV-2015, reported as "6 weeks ago", the patient was vaccinated with a dose of PNEUMOVAX 23, subcutaneous, (dose, lot number, expiration date and anatomical location were not reported). There were no concomitant medications reported. On 27-NOV-2015, immediately after vaccination, the patient felt lethargic and her arm hurt "kind of a flu shot". The outcome of lethargy and pain in extremity was reported as recovered/resolved on approximately 29-NOV-2015 reported as "three days after receiving shot". The reporter did not assess the relatedness of lethargy and pain in extremity with PNEUMOVAX 23. Additional information is not expected because the reporter did not want to be contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. Since 03-DEC-2015 unknown number of patients were vaccinated with improperly stored VARIVAX (dosing regimen and lot # unspecified). No concomitant medications reported. No adverse effects reported. There was no product quality complaint involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous report was received from a physician referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. On 15-DEC-2015, the patient was inadvertently administered an expired dose of VAQTA injection (lot # J005081 with expiration date 22-OCT-2015; dose and route were not provided). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 19-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K019502 with expiration date 14-FEB-2016. No adverse effects were reported. 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: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # J013394 with expiration date 25-AUG-2016. No adverse effects were reported. 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: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 14-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K019502 with expiration date 14-FEB-2016. No adverse effects were reported. 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: This spontaneous report as received from a health care professional refer to multiple unspecified patients of unknown demographics. Since 03-DEC-2015 unknown number of patients were vaccinated with improperly stored PROQUAD (Merck) (dosing regimen unspecified) (dosing regimen and lot # unspecified). No concomitant medications reported. No adverse effects reported. There was no product quality complaint involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a consumer via twitter. The reported tweeted an article. This report refers to a 11240 patients of an unknown age and gender who visited the emergency room after receiving a dose of GARDASIL (dose, route, lot # and expiration date were not provided) on unspecified dates. This is one of several reports received from the same reporter. Additional information is not expected as reporter details were not provided.