chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Micturition urgency, Muscle twitching, Muscular weakness, Nausea, Neck pain
Clinical narrative: Patient first evaluated by Clinic 3/2018. Reports in January 2018 reported some low back pain after working with a snow blower. A few weeks after this, noted some rectal and bladder burning and 'urgency' - lasted 4-5 days and then resolved. Toward the end of Jan, flew to and back and had trouble getting out the airplane seat. In February 2018 went snowshoeing and fell, noted legs aching. Noted decreased power in the quads bilaterally and this progressed to a feeling 'like my legs are disconnected from me, like my quads are weak.' Early March 2018, symptoms progressed and more noticeable. Felt like knees might give out when getting up and down. Went to the ED - had cardiac/syncope r/o on telemetry. Didn't mention his lower extremity concerns during that visit. Symptoms continued. In April, patient reported legs "feeling buzzy", some numbness in upper extremities, particularly bilat pinky fingers, pins and needles from biceps to tips of fingers. Towards end of April, some abdominal pain reported, intermittently, decreased appetite. Some SOB, had panic attack, situational anxiety. Patient seen again in May, continued progression of paresthesias in upper extremities. Reports having "fogginess" worse in AM, feeling jittery, sometimes has the sense that "brain is on fire." Reported feeling anxious, ongoing. Frontal HA and neck pain reported. Situational anxiety ongoing. Passive suicidal thoughts with no plan or intent.  End of May reported arms and legs feeling worse, losing strength despite exercise; unintended weight loss, GI cramps; twitching in arms, legs, hands, L>R; headaches; mild cognitive foggy feeling; anxiety. Seen by office in early June, reported legs still feeling numb and "on fire", but overall better; HA and neck pain. Late June reported feeling jittery, anxious, with sense of doom. Again reported passive suicidality with no plan or intent; continued weight loss, bowel movements every 3-4 days with abdominal cramping, nausea. Discussed seeing a psychiatrist for ongoing anxiety. Seen multiple times between March and July with ongoing symptoms; saw several specialists for workup during this time. Most recently seen by our office 7/2/2018, plan to return to work discussed. Ongoing HAs, constipation, situational anxiety. Called office 7/9 feeling jittery and with mental fogginess and forgetfulness, SOB with exercise. Plan to see gastroenterology 7/10 for further testing. 7/10/18 self inflicted gunshot wound, patient deceased.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Oesophagogastroduodenoscopy, Pain in extremity, Panic attack
Clinical narrative: Patient first evaluated by Clinic 3/2018. Reports in January 2018 reported some low back pain after working with a snow blower. A few weeks after this, noted some rectal and bladder burning and 'urgency' - lasted 4-5 days and then resolved. Toward the end of Jan, flew to and back and had trouble getting out the airplane seat. In February 2018 went snowshoeing and fell, noted legs aching. Noted decreased power in the quads bilaterally and this progressed to a feeling 'like my legs are disconnected from me, like my quads are weak.' Early March 2018, symptoms progressed and more noticeable. Felt like knees might give out when getting up and down. Went to the ED - had cardiac/syncope r/o on telemetry. Didn't mention his lower extremity concerns during that visit. Symptoms continued. In April, patient reported legs "feeling buzzy", some numbness in upper extremities, particularly bilat pinky fingers, pins and needles from biceps to tips of fingers. Towards end of April, some abdominal pain reported, intermittently, decreased appetite. Some SOB, had panic attack, situational anxiety. Patient seen again in May, continued progression of paresthesias in upper extremities. Reports having "fogginess" worse in AM, feeling jittery, sometimes has the sense that "brain is on fire." Reported feeling anxious, ongoing. Frontal HA and neck pain reported. Situational anxiety ongoing. Passive suicidal thoughts with no plan or intent.  End of May reported arms and legs feeling worse, losing strength despite exercise; unintended weight loss, GI cramps; twitching in arms, legs, hands, L>R; headaches; mild cognitive foggy feeling; anxiety. Seen by office in early June, reported legs still feeling numb and "on fire", but overall better; HA and neck pain. Late June reported feeling jittery, anxious, with sense of doom. Again reported passive suicidality with no plan or intent; continued weight loss, bowel movements every 3-4 days with abdominal cramping, nausea. Discussed seeing a psychiatrist for ongoing anxiety. Seen multiple times between March and July with ongoing symptoms; saw several specialists for workup during this time. Most recently seen by our office 7/2/2018, plan to return to work discussed. Ongoing HAs, constipation, situational anxiety. Called office 7/9 feeling jittery and with mental fogginess and forgetfulness, SOB with exercise. Plan to see gastroenterology 7/10 for further testing. 7/10/18 self inflicted gunshot wound, patient deceased.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Polymerase chain reaction, Protein total increased, Renal cyst, Suicidal ideation
Clinical narrative: Patient first evaluated by Clinic 3/2018. Reports in January 2018 reported some low back pain after working with a snow blower. A few weeks after this, noted some rectal and bladder burning and 'urgency' - lasted 4-5 days and then resolved. Toward the end of Jan, flew to and back and had trouble getting out the airplane seat. In February 2018 went snowshoeing and fell, noted legs aching. Noted decreased power in the quads bilaterally and this progressed to a feeling 'like my legs are disconnected from me, like my quads are weak.' Early March 2018, symptoms progressed and more noticeable. Felt like knees might give out when getting up and down. Went to the ED - had cardiac/syncope r/o on telemetry. Didn't mention his lower extremity concerns during that visit. Symptoms continued. In April, patient reported legs "feeling buzzy", some numbness in upper extremities, particularly bilat pinky fingers, pins and needles from biceps to tips of fingers. Towards end of April, some abdominal pain reported, intermittently, decreased appetite. Some SOB, had panic attack, situational anxiety. Patient seen again in May, continued progression of paresthesias in upper extremities. Reports having "fogginess" worse in AM, feeling jittery, sometimes has the sense that "brain is on fire." Reported feeling anxious, ongoing. Frontal HA and neck pain reported. Situational anxiety ongoing. Passive suicidal thoughts with no plan or intent.  End of May reported arms and legs feeling worse, losing strength despite exercise; unintended weight loss, GI cramps; twitching in arms, legs, hands, L>R; headaches; mild cognitive foggy feeling; anxiety. Seen by office in early June, reported legs still feeling numb and "on fire", but overall better; HA and neck pain. Late June reported feeling jittery, anxious, with sense of doom. Again reported passive suicidality with no plan or intent; continued weight loss, bowel movements every 3-4 days with abdominal cramping, nausea. Discussed seeing a psychiatrist for ongoing anxiety. Seen multiple times between March and July with ongoing symptoms; saw several specialists for workup during this time. Most recently seen by our office 7/2/2018, plan to return to work discussed. Ongoing HAs, constipation, situational anxiety. Called office 7/9 feeling jittery and with mental fogginess and forgetfulness, SOB with exercise. Plan to see gastroenterology 7/10 for further testing. 7/10/18 self inflicted gunshot wound, patient deceased.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Treponema test negative, Varicella virus test positive, Vitamin B1, Vitamin B12 normal, Vitamin D
Clinical narrative: Patient first evaluated by Clinic 3/2018. Reports in January 2018 reported some low back pain after working with a snow blower. A few weeks after this, noted some rectal and bladder burning and 'urgency' - lasted 4-5 days and then resolved. Toward the end of Jan, flew to and back and had trouble getting out the airplane seat. In February 2018 went snowshoeing and fell, noted legs aching. Noted decreased power in the quads bilaterally and this progressed to a feeling 'like my legs are disconnected from me, like my quads are weak.' Early March 2018, symptoms progressed and more noticeable. Felt like knees might give out when getting up and down. Went to the ED - had cardiac/syncope r/o on telemetry. Didn't mention his lower extremity concerns during that visit. Symptoms continued. In April, patient reported legs "feeling buzzy", some numbness in upper extremities, particularly bilat pinky fingers, pins and needles from biceps to tips of fingers. Towards end of April, some abdominal pain reported, intermittently, decreased appetite. Some SOB, had panic attack, situational anxiety. Patient seen again in May, continued progression of paresthesias in upper extremities. Reports having "fogginess" worse in AM, feeling jittery, sometimes has the sense that "brain is on fire." Reported feeling anxious, ongoing. Frontal HA and neck pain reported. Situational anxiety ongoing. Passive suicidal thoughts with no plan or intent.  End of May reported arms and legs feeling worse, losing strength despite exercise; unintended weight loss, GI cramps; twitching in arms, legs, hands, L>R; headaches; mild cognitive foggy feeling; anxiety. Seen by office in early June, reported legs still feeling numb and "on fire", but overall better; HA and neck pain. Late June reported feeling jittery, anxious, with sense of doom. Again reported passive suicidality with no plan or intent; continued weight loss, bowel movements every 3-4 days with abdominal cramping, nausea. Discussed seeing a psychiatrist for ongoing anxiety. Seen multiple times between March and July with ongoing symptoms; saw several specialists for workup during this time. Most recently seen by our office 7/2/2018, plan to return to work discussed. Ongoing HAs, constipation, situational anxiety. Called office 7/9 feeling jittery and with mental fogginess and forgetfulness, SOB with exercise. Plan to see gastroenterology 7/10 for further testing. 7/10/18 self inflicted gunshot wound, patient deceased.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: White blood cell count decreased
Clinical narrative: Patient first evaluated by Clinic 3/2018. Reports in January 2018 reported some low back pain after working with a snow blower. A few weeks after this, noted some rectal and bladder burning and 'urgency' - lasted 4-5 days and then resolved. Toward the end of Jan, flew to and back and had trouble getting out the airplane seat. In February 2018 went snowshoeing and fell, noted legs aching. Noted decreased power in the quads bilaterally and this progressed to a feeling 'like my legs are disconnected from me, like my quads are weak.' Early March 2018, symptoms progressed and more noticeable. Felt like knees might give out when getting up and down. Went to the ED - had cardiac/syncope r/o on telemetry. Didn't mention his lower extremity concerns during that visit. Symptoms continued. In April, patient reported legs "feeling buzzy", some numbness in upper extremities, particularly bilat pinky fingers, pins and needles from biceps to tips of fingers. Towards end of April, some abdominal pain reported, intermittently, decreased appetite. Some SOB, had panic attack, situational anxiety. Patient seen again in May, continued progression of paresthesias in upper extremities. Reports having "fogginess" worse in AM, feeling jittery, sometimes has the sense that "brain is on fire." Reported feeling anxious, ongoing. Frontal HA and neck pain reported. Situational anxiety ongoing. Passive suicidal thoughts with no plan or intent.  End of May reported arms and legs feeling worse, losing strength despite exercise; unintended weight loss, GI cramps; twitching in arms, legs, hands, L>R; headaches; mild cognitive foggy feeling; anxiety. Seen by office in early June, reported legs still feeling numb and "on fire", but overall better; HA and neck pain. Late June reported feeling jittery, anxious, with sense of doom. Again reported passive suicidality with no plan or intent; continued weight loss, bowel movements every 3-4 days with abdominal cramping, nausea. Discussed seeing a psychiatrist for ongoing anxiety. Seen multiple times between March and July with ongoing symptoms; saw several specialists for workup during this time. Most recently seen by our office 7/2/2018, plan to return to work discussed. Ongoing HAs, constipation, situational anxiety. Called office 7/9 feeling jittery and with mental fogginess and forgetfulness, SOB with exercise. Plan to see gastroenterology 7/10 for further testing. 7/10/18 self inflicted gunshot wound, patient deceased.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Extreme nausea, severe headache, chills, fever of 100.5, tiredness, lasted 15 hours.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diplopia, Fatigue, Myalgia, Pain
Clinical narrative: Extreme body pain muscle and joint. Extreme fatigue unable to do anything it's been 2 days. Double vision 2 days.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test, Oedema, Oedema peripheral, Pyrexia, Weight increased
Clinical narrative: Noted low grade fever (later that evening of injection) x 2 days which has entirely resolved. Since that time has noted bilateral lower extremity edema which has become pitting over the past several days---states 11 pounds of water weight since edema noted. She was assessed at a local urgent care center yesterday for work up and evaluation. No chest pain or SOB. Currently still has this condition.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Vaccination site pustule, Vaccination site reaction
Clinical narrative: Classic appearance of zoster lesions in a 3 cm patch around the vaccination site. Coalesced pustules on a surrounding red patch.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Blood in stool the day following vaccine administration.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was to receive MMR and Varicella. She was inadvertently given MMRV and Varicella. Per doctor patient should not have any ill effects from receiving the double dose of Varicella. Mom was notified and at the time of call patient was sleeping and was not showing any signs or symptoms.  As of this time patient has not had any ill effects reported by mom.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 14-year-old female patient. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 21-MAR-2018, the patient was vaccinated in the right arm with improperly stored 8th dose of GARDASIL 9, intramuscularly (lot # M041990 (also reported as N041990), expiration date: 28-JUN-2019, dose, strength and frequency were not provided) for prophylaxis. Administered vaccine experienced the temperature excursion of 31 degrees Fahrenheit for 2 hours. Digital data logger was involved to capture the temperature excursion. There was no previous excursion reported. No adverse effects were reported.
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Feeling abnormal, Hypersensitivity, Nausea
Clinical narrative: This is a spontaneous report from a contactable nurse (patient's mother). A 17-year-old female patient received the first dose of TRUMENBA, lot number: S85201, expiration date: 30Dec2019), via an unspecified route of administration on 19Jul2018 at a single dose for immunization, reported as for Meningitis B. Medical history included low blood pressure (low blood pressure kind of thing going on at one point about a year ago). The patient's concomitant medications were not reported. The mother reported that she had identical twins 17 year old daughters and were pretty small for their age only like a 100 pounds. It was reported that the mother and her daughters went to their pediatrician on 19Jul2018 (Thursday) and had the meningococcal group b rlp2086 first shot given to them of the vaccines for the meningitis B. On an unspecified date, the patient experienced chills, dizziness, nausea, she was a little hyper sensitive, she started feeling weird symptoms through her body, just not feeling right and had like low grade fevers again and it was a 100 only like low grade. The mother further reported that the other daughter had chills and nausea and that the patient had chills and nausea and hours later had dizziness. The mother also reported that the patient said maybe in her body it just kind of like one of these things where she was a little hyper sensitive because they are twin sisters and she started her period which was like that night. It was reported that the patient had a delayed reaction like hours later but before bed she started feeling weird symptoms through her body. The mother reported that the patient was feeling same like the other daughter like hours later so the feeling through the body, dizziness, just not feeling right and they had like low grade fevers again and it was a 100 only like low grade. Outcome of all the events was unknown.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse (patient's mother). A 17-year-old female patient received the first dose of TRUMENBA, lot number: S85201, expiration date: 30Dec2019), via an unspecified route of administration on 19Jul2018 at a single dose for immunization, reported as for Meningitis B. Medical history included low blood pressure (low blood pressure kind of thing going on at one point about a year ago). The patient's concomitant medications were not reported. The mother reported that she had identical twins 17 year old daughters and were pretty small for their age only like a 100 pounds. It was reported that the mother and her daughters went to their pediatrician on 19Jul2018 (Thursday) and had the meningococcal group b rlp2086 first shot given to them of the vaccines for the meningitis B. On an unspecified date, the patient experienced chills, dizziness, nausea, she was a little hyper sensitive, she started feeling weird symptoms through her body, just not feeling right and had like low grade fevers again and it was a 100 only like low grade. The mother further reported that the other daughter had chills and nausea and that the patient had chills and nausea and hours later had dizziness. The mother also reported that the patient said maybe in her body it just kind of like one of these things where she was a little hyper sensitive because they are twin sisters and she started her period which was like that night. It was reported that the patient had a delayed reaction like hours later but before bed she started feeling weird symptoms through her body. The mother reported that the patient was feeling same like the other daughter like hours later so the feeling through the body, dizziness, just not feeling right and they had like low grade fevers again and it was a 100 only like low grade. Outcome of all the events was unknown.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 18-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 years old female patient who experienced extra dose of MENACTRA given to patient, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that patient's last menstrual period was 09-Jul-2018 and patient not pregnant. Concomitant medications included HPV VACCINE for Immunisation; and BEXSERO for Immunisation. It was a case of actual medication error due to extra dose administered. It was unknown if any adverse event was occurred or not following the administration. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. The outcome was not applicable. Documents held by the sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial unsolicited report received from a nurse on 18-Jul-2018. This case involves a 4-years-old male patient who was vaccinated with a fifth dose of suspect 0.5 ml IMOVAX POLIO (batch number: N1K921M, expiration date: 14-Nov-2019, frequency: once) via subcutaneous in upper left arm on 16-Jul-2018 and this dose was involved in a temperature excursion (opened vial 55.2 F for 4 hours). The patient's medical history was not reported. Concomitant medications included DAPTACEL for Immunisation. It was an actual medication error due to extra dose administered and incorrect product storage. The patient had no signs of any adverse reaction at the time of report. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: IPV
Symptoms: Product administered at inappropriate site, Underdose
Clinical narrative: Initial unsolicited report received from a nurse on 18-Jul-2018. This case involves a 17-years-old female patient (reported as 17 years 9 month old) who was vaccinated with an incomplete dose of suspect 0.1 ml IMOVAX POLIO (batch number: N1A451M, expiration date: 09-Feb-2019, frequency: once) via subcutaneous in left forearm on 18-Jul-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to vaccine administered at inappropriate site and vaccine underdose. It was not known whether patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Chills, Culture throat negative, Dyskinesia, Lethargy, Pyrexia
Clinical narrative: Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to cases 2018SA200801 and 2018SA200797 (same reporter). This case involves a four-years old female patient who experienced lethargy, fever (98.8-100.3 temporal), shivers, vomiting and jerking (unlikely seizure), while she received vaccine QUADRACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccinations were given. No other concomitant therapies were reported. On 16-Jul-2018, the patient received a first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5497AA, exp date: 17-July-2020 via intramuscular route in the right thigh. On 16-Jul-2018, same evening, the patient developed a non-serious lethargy, fever (98.8-100.3 temporal) (pyrexia), shivers (chills), vomiting and jerking (unlikely seizure) (dyskinesia). Other relevant tests included throat culture and it was negative. Final diagnosis was jerking (unlikely seizure), vomiting, shivers, fever (98.8-100.3 temporal) and lethargy. The patient was treated with Ibuprofen (Motrin) for Pyrexia. The patient outcome was unknown for all reported events. Documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Vomiting
Clinical narrative: Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to cases 2018SA200801 and 2018SA200797 (same reporter). This case involves a four-years old female patient who experienced lethargy, fever (98.8-100.3 temporal), shivers, vomiting and jerking (unlikely seizure), while she received vaccine QUADRACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccinations were given. No other concomitant therapies were reported. On 16-Jul-2018, the patient received a first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5497AA, exp date: 17-July-2020 via intramuscular route in the right thigh. On 16-Jul-2018, same evening, the patient developed a non-serious lethargy, fever (98.8-100.3 temporal) (pyrexia), shivers (chills), vomiting and jerking (unlikely seizure) (dyskinesia). Other relevant tests included throat culture and it was negative. Final diagnosis was jerking (unlikely seizure), vomiting, shivers, fever (98.8-100.3 temporal) and lethargy. The patient was treated with Ibuprofen (Motrin) for Pyrexia. The patient outcome was unknown for all reported events. Documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from Nurse. This case involves a 10 years old male patient who received IPOL which was from vial opened at 46.04 degrees for 34 minutes on 27 Jun 2018. Patient received two POLIO VACCINE LIVE ORAL in the past on an unknown date, other medical history was not reported. Concomitant medication was not reported. On 06-Jul-2018, the patient received a 0.5 ml single dose of suspect IPOL lot N1K931M, expiry date: 18-Nov-2019 via intramuscular route in the left arm. On 06-Jul-2018, the patient also received a dose of PREVNAR 13 and HEPATITIS B VACCINE. It was a case of actual medication error due to product storage error. It was reported that IPOL was from vial opened at 46.04 degrees for 34 minutes. It was not reported if adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old male patient who experienced expired dose was administered to consumer, while he received vaccines HEPATITIS B VACCINE and PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Sep-2017, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE lot number not reported via unknown route in the deltoid NOS. On an unknown date, the patient received a dose of suspect HEPATITIS B VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. The patient developed a non-serious expired dose was administered to consumer following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE and following the administration of HEPATITIS B VACCINE. (Other relevant tests included No lab data). Final diagnosis was expired dose was administered to consumer. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for expired dose was administered to consumer. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a patient of an unknown demographics who received an expired dose of vaccine PENTACEL (lot number, expiry date, route and site of administration were not reported). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. PENTACEL was administered to a patient and the dose expired the day prior. It was not reported if patient had any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: HPV4, TDAP
Symptoms: Syncope
Clinical narrative: Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult patient who experienced patient had fainting, while he/she received vaccines GARDASIL and ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect GARDASIL not produced by Sanofi Pasteur lot number not reported via unknown route. On an unknown date, the patient received a dose of suspect Diptheria-2/Tetanus/5 AC Pertussis vaccine lot number not reported via unknown route. The patient developed a non-serious patient had fainting (syncope) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis vaccine and following the administration of GARDASIL. (Other relevant tests included No lab data.) Final diagnosis was patient had fainting. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for patient had fainting.
Sex: U
Vaccine: DTAPIPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult patient who experienced swelling and fever, while he/she received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect QUADRACEL lot number not reported via unknown route in unknown administration site. The patient developed a non-serious swelling following the administration of QUADRACEL. The patient developed a non-serious fever (pyrexia) following the administration of QUADRACEL. Patient had emergency room (ER) visit. (Other relevant tests included No lab test.) Final diagnosis was fever and swelling. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for swelling and as Unknown for fever.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Expired product administered
Clinical narrative: PCV13 outdated on 06/30/2018 and was not removed from fridge.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Escalating pain in arm by 4 hours. Increased until it was VERY bad (and I have always had a high pain threshold). Moving the arm in any way was excruciating.  After movement, I'd have to wait about 5 minutes for the pain to drop to merely very painful. After another couple of hours got chills and shivering, which lasted about three hours. The pain in my arm, without movement, was my entire world. I thought about getting up to take an oxycodone left from previous eye surgery, but concluded that the pain from moving my arm during getting and taking the tablet would be too much, given how high the "background" pain was. I was having trouble thinking straight and actually selected a point in symptoms at which I would call 911, because I was afraid that if it kept escalating I would be unable to do so. After about 6 am, everything began improving, and pain gradually dropped to merely uncomfortable when moving my arm. This was by far the worst prolonged pain and discomfort I've ever experienced. I would happily choose shingles over this experience, and I know how bad shingles can be.
Age: 1.83
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema
Clinical narrative: Erythematous area 4x3.5 cm diameter on the left deltoid.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Says is being treated for cellulitis.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Urticaria
Clinical narrative: PATIENT DEVELOPED AN URTICARIA ALL OVER THE BODY. NO OTHER SYMPTOMS.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Warm rash on arm.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea
Clinical narrative: Patient is having extreme, constant diarrhea. Patient is completely potty trained, but is now having to wear Pull-Ups 24/7 until this is resolved.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Influenza like illness, Muscular weakness
Clinical narrative: Chills, fever, fatigue, soreness, muscle weakness, flu-like symptoms, stomach pain, shoulder pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain, Pyrexia
Clinical narrative: Chills, fever, fatigue, soreness, muscle weakness, flu-like symptoms, stomach pain, shoulder pain.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Malaise, Visual impairment
Clinical narrative: Complaint is subjective: Patient and parent called to inform facility that once patient made it home she became sick. She work up around 4AM the next morning and walked to the bathroom she became dizzy she grabbed onto the sink and started to see dark spots and she woke up later on the floor. She stated she woke up on her own. She stated she don't recall how long she was out. I told parent and patient to report to the ER for observation even if she feels better.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Dyskinesia, Injection site erythema, Injection site scar, Insomnia, Pyrexia
Clinical narrative: Patient began running fever at 9 PM the night of May 22nd. I checked it under his arm after he was screaming from his room and would not sleep. It read 104 under the arm. He would not respond to stimuli, was very still while holding him, and had body jerking. We gave him TYLENOL, although he didn't take it well, and took him to the ER. The ER and his doctor's office claimed he was fine as the TYLENOL brought his fever down slightly, and they told me the vaccines did not cause this. I left the ER and he was not seen due to me needing to be home with my other son as well. The ER was slow and did not process patient through in a timely manner. Patient slept next to me that night and ran fever the next day. His right thigh had a massive red mark from one of the injection sites, and it still has scarring two months later.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Screaming, Unresponsive to stimuli
Clinical narrative: Patient began running fever at 9 PM the night of May 22nd. I checked it under his arm after he was screaming from his room and would not sleep. It read 104 under the arm. He would not respond to stimuli, was very still while holding him, and had body jerking. We gave him TYLENOL, although he didn't take it well, and took him to the ER. The ER and his doctor's office claimed he was fine as the TYLENOL brought his fever down slightly, and they told me the vaccines did not cause this. I left the ER and he was not seen due to me needing to be home with my other son as well. The ER was slow and did not process patient through in a timely manner. Patient slept next to me that night and ran fever the next day. His right thigh had a massive red mark from one of the injection sites, and it still has scarring two months later.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness and edema of upper left arm that lasted about 1 week.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 74-year-old patient who received SHINGRIX for prophylaxis. The patient's past medical history included genital herpes (outbreaks on labia and buttock). Previously administered products included shingles vaccine (She had the shingles vaccine 9 years before the reporting date), Valtrex and Hydrocortisone cream. Concurrent medical conditions included burn (put a hot pot too close to her stomach and got a burn 2 inches on her stomach), erythema, pruritus and topical adhesive allergy. Concomitant products included Herpes zoster SHINGRIX. On 6th July 2018, the patient received the 2nd dose of SHINGRIX. On 7th July 2018, 1 days after receiving SHINGRIX, the patient experienced vesicular rash, erythema, pruritus aggravated, blister and burn. The patient was treated with valaciclovir hydrochloride (Valtrex). On 8th July 2018, the outcome of the pruritus aggravated was recovered/resolved. On an unknown date, the outcome of the vesicular rash was unknown and the outcome of the erythema, blister and burn were not recovered/not resolved. It was unknown if the reporter considered the vesicular rash, erythema, pruritus aggravated, blister and burn to be related to SHINGRIX. Additional details were provided as follows: The patient reported that in her 30s she contracted herpes progenitalis from her husband and she would have outbreaks on her labia and buttock when she was under stress. The patient went to an gynecologist in her 40s where he prescribed Valtrex. The patient could take Valtrex when she got an outbreak and also prophylactically for years.  The patient could take Valtrex 1,000 mg for 5 days and she had been on Valtrex since her 40's.  The patient said that she was not continuously taking Valtrex. The patient was not taking Valtrex when she burned. This was not an event as the patient was not on any medication made by GlaxoSmithKline at that point. The patient used band aid on the burn and after she started having redness and itchiness around the band aid. The patient went to an urgent care and the physician thought that she was becoming allergic to the adhesive. The patient used hydrocortisone cream which did not help. In April 2018, the patient received 1st dose of SHINGRIX. On Friday, the patient received 2nd dose over two months after 1st dose. On Saturday, the day after the vaccination, the patient noticed that the area around the band aid was blistery, burning, the redness spread and grew in size, got more itchy and distinctly more red. On Sunday, at night, the patient took 1,000 mg of Valtrex at around 9:30 pm and then at 3:30 am the itching went away. The patient was concerned and did not know if this was herpes or shingles. The patient did not have herpes on the stomach before but it looked like herpes. The patient was concerned it could also be shingles. Since the patient got the vaccine for shingles recently and she was waiting to hear back from the dermatologist to get a diagnosis. The reporter provided conatct details of the physician.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a female patient who received SHINGRIX for prophylaxis. On 6th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In July 2018, 1 day after receiving SHINGRIX, the patient experienced erythema of extremities, skin warm, local swelling and pain localized. On an unknown date, the outcome of the erythema of extremities was recovering/resolving and the outcome of the skin warm, local swelling and pain localized were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, skin warm, local swelling and pain localized to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the pharmacist who was the patient herself. The patient was administered SHINGRIX vaccine in the left arm. The patient woke up next day and had tennis ball size red mark on her arm. It was about 3 inches wide and 2 inches long. The area was also raised, swollen, painful and hot. The redness was still present on her arm. The reporter denied permission to contact her health care physician. No further details were provided.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pustule, Injection site warmth
Clinical narrative: Came in 7/26/18 reported injection site reaction on left arm warmth redness and painful pustule that started 5 days prior (7/21/18). No reported initial reaction but said started feeling warm a week later.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Erythema, Nausea, Skin warm, Swelling
Clinical narrative: Red "bump", 3.25" x 3", raised, warm, sore to touch, minimal nausea, minimal dizziness.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Tenderness
Clinical narrative: Red "bump", 3.25" x 3", raised, warm, sore to touch, minimal nausea, minimal dizziness.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chapped lips, Fatigue, Feeling abnormal, Hot flush
Clinical narrative: Saw the medical personnel, not Dr. - on vacation. I have not felt right since I had this vaccine. I was very sick with pain-body aches, soreness, throughout body, rash on arms, back of hands, top of fingers, rash around mouth and on front of neck and at waist on both sides of belly button. Body felt raw inside, mouth and tongue very dry, lips pale; and some chapping, itchy, stinging, sensation over body. Hot flushes would go over my body and go off at a feeling of sensation. I felt like my body was not mine, legs and arms felt heavy, log like sometimes, felt out of body. Swelling in knees and thighs. After almost 2 months, NP prescribed BENADRYL. After taking some, I just now begin to feel better, however I still feel tired, lack of energy and settle unwell feeling throughout my body. I have never experienced this type of long lasting pain, body aches, soreness, itchy all over my body - it was very scary.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Joint swelling, Limb discomfort, Malaise, Oral mucosal eruption, Pain
Clinical narrative: Saw the medical personnel, not Dr. - on vacation. I have not felt right since I had this vaccine. I was very sick with pain-body aches, soreness, throughout body, rash on arms, back of hands, top of fingers, rash around mouth and on front of neck and at waist on both sides of belly button. Body felt raw inside, mouth and tongue very dry, lips pale; and some chapping, itchy, stinging, sensation over body. Hot flushes would go over my body and go off at a feeling of sensation. I felt like my body was not mine, legs and arms felt heavy, log like sometimes, felt out of body. Swelling in knees and thighs. After almost 2 months, NP prescribed BENADRYL. After taking some, I just now begin to feel better, however I still feel tired, lack of energy and settle unwell feeling throughout my body. I have never experienced this type of long lasting pain, body aches, soreness, itchy all over my body - it was very scary.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pallor, Peripheral swelling, Pruritus, Rash, Tongue dry
Clinical narrative: Saw the medical personnel, not Dr. - on vacation. I have not felt right since I had this vaccine. I was very sick with pain-body aches, soreness, throughout body, rash on arms, back of hands, top of fingers, rash around mouth and on front of neck and at waist on both sides of belly button. Body felt raw inside, mouth and tongue very dry, lips pale; and some chapping, itchy, stinging, sensation over body. Hot flushes would go over my body and go off at a feeling of sensation. I felt like my body was not mine, legs and arms felt heavy, log like sometimes, felt out of body. Swelling in knees and thighs. After almost 2 months, NP prescribed BENADRYL. After taking some, I just now begin to feel better, however I still feel tired, lack of energy and settle unwell feeling throughout my body. I have never experienced this type of long lasting pain, body aches, soreness, itchy all over my body - it was very scary.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Firm swelling of deltoid area to mid-forearm with increased warmth and slight redness, and tenderness along arm.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Laboratory test abnormal, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever to 103F, Severe R arm pain and swelling shortly following injection. Approximately 2 weeks after the initial immune reaction patient reports significant diffuse hair loss that have persisted since that time. No other new medications/illnesses/stressors.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Dyspnoea, Eye swelling, Hyperhidrosis
Clinical narrative: After administration of Tdap, MENACTRA and Hep A patient immediately began to feel light headed, skin clammy/sweaty, nauseous. Condition progressed to patient complaining of tongue and throat feeling swollen, shortness of breath, numbness to extremities, pain to touch of skin, felt that eyes and nasal passages felt swollen. Patient was laid down on table, assessed by nurse, given cold compresses to head and arms. EMS was notified and responded for transport to the hospital.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Nasal congestion, Nausea, Pain of skin
Clinical narrative: After administration of Tdap, MENACTRA and Hep A patient immediately began to feel light headed, skin clammy/sweaty, nauseous. Condition progressed to patient complaining of tongue and throat feeling swollen, shortness of breath, numbness to extremities, pain to touch of skin, felt that eyes and nasal passages felt swollen. Patient was laid down on table, assessed by nurse, given cold compresses to head and arms. EMS was notified and responded for transport to the hospital.