chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.42
Sex: M
Vaccine: HIBV, DTAP, HIBV, IPV, PNC13
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 07-MAY-2016, the patient was inadvertently vaccinated with improperly stored PEDVAXHIB (lot # L042835 and expiration date 19-AUG-2018, dose and route of administration were not reported). Concomitant therapy was not reported. The temperature of excursion was 31.5F and the time frame was 11 hours. There was no previous temperature excursion and the call was because of the data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 34.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 34-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L035881, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in left deltoid (a dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 09-MAY-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L013063 and expiration date 14-APR-2017, dose and route of administration were not reported). Concomitant therapy was not reported. The temperature of excursion was 29F and the time frame was 2 hours. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 35.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead referring to a 35-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L035881, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in right deltoid (a dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Complex regional pain syndrome
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to two female patients (sisters) of unknown age. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated intramuscularly with unidentified Merck HPV vaccine (name, lot number, expiration date and dose were not provided). It was unspecified whether the patients received GARDASIL or GARDASIL 9 and how many doses they received. Concomitant therapy was not reported. On unknown dates, while receiving unidentified Merck HPV vaccine, the patients were diagnosed with reflex sympathetic dystrophy syndrome. The outcome of the events was not reported. The relatedness between the events and unidentified Merck HPV vaccine was not reported. Additional information has been requested.
Age: 21.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead referring to a 21-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L035881, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in right deltoid (a dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients received doses of improperly stored VARIVAX (lot # K016131, expiration date: 23-SEP-2016; lot # L024252, expiration date: 30-JUN-2017; lot # L016123, expiration date: 06-MAY-2017; dose and route were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients received doses of improperly stored ZOSTAVAX (lot # L021609, expiration date: 10-SEP-2016; lot # L035284, expiration date: 15-DEC-2016; lot # L029484, expiration date: 06-NOV-2016; dose and route were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. 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 was received from a medical assistant and refers to multiple unspecified patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients received doses of improperly stored PROQUAD (Merck) (lot # L025204, expiration date: 07-JAN-2017; lot # reported as M010476, expiration date: 01-SEP-2017; lot # L050909, expiration date: 14-JUN-2017; lot # L031601, expiration date: 18-FEB-2017; lot # reported as L026602, expiration date: 24-SEP-2016; dose and route were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On 18-MAY-2016, the patient was inadvertently vaccinated with a dose of improperly stored M-M-R II lot # L030162, expiration date reported as 11-AUG-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 50.9 degrees Fahrenheit for 1 hour 30 minutes. Data logger was involved. There were no previous temperature excursions reported. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Fall, Laceration, Platelet count decreased, Suture insertion
Clinical narrative: This spontaneous report as received from a nurse refers to a 3 year old patient of unknown gender. The patient's pertinent medical history and current conditions were not reported. On 02-MAY-2016 the patient was vaccinated with first dose of VARIVAX (lot # L023588, expiry date not reported) (dose, route of administration were not reported). No other vaccine was administered on 02-MAY-2016. The reporter stated that as per patient's mother on an unknown date in May 2016, one to two days post vaccination, patient experienced a fall and had a cut finger (fall and injury). The patient was taken to unspecified emergency visit on 05-MAY-2016 for suturing of cut on finger at which time unspecified blood work was taken from patient. The reporter stated that patient's platelet count was not elevated, it was decreased to 67 (units not reported) (platelet count decreased). The reporter stated that the patient is due to come into office for repeat blood work. The outcome of the events was not reported. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L035836, expiration date 19-AUG-2017 (exact dose was not reported, orally). There was no adverse effect reported. Administered doses experienced the temperature excursion of 48.7 degrees Fahrenheit for 24 hours. There was no previous temperature excursions. A data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Red patches, itching, hives.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: Severe joint pain in knees. Difficult to walk, move; no over the counter pain medication provides any relief. Same reaction occurred with the second dose of the same vaccine.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Imaging procedure, Lumbar puncture abnormal, Scan abnormal
Clinical narrative: Acute Demyelinating Process, Guillain Barre.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Constipation, Flatulence, Productive cough
Clinical narrative: Coughing up phlegm, constipation, gas, sour arm. As of 5/22/16 symptoms still remain. I went online and read bacteria degrades protein by process called ribosylation. That large doses of nicotinamide can stop the process. I tried it symptoms stopped. After a month I stopped taking nicotinamide symtoms returned. I started taking it again symptom remain.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Constipation, Erythema, Flatulence, Injection site pain, Laboratory test normal
Clinical narrative: Coughing up phlegm, constipation, gas, sour arm. As of 5/22/16 symptoms still remain. I went online and read bacteria degrades protein by process called ribosylation. That large doses of nicotinamide can stop the process. I tried it symptoms stopped. After a month I stopped taking nicotinamide symtoms returned. I started taking it again symptom remain.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Muscle spasms, Peripheral swelling, Productive cough, Skin warm, Tenderness
Clinical narrative: Coughing up phlegm, constipation, gas, sour arm. As of 5/22/16 symptoms still remain. I went online and read bacteria degrades protein by process called ribosylation. That large doses of nicotinamide can stop the process. I tried it symptoms stopped. After a month I stopped taking nicotinamide symtoms returned. I started taking it again symptom remain.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Axillary pain, Insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Intense pain in arm that vaccine was given.  Started off just sore but a few days later pain intensified and has gotten worse every day.  Now, 2 weeks later, I am having trouble lifting things and cannot sleep due to the pain.  Pain is in my shoulder, armpit and down to my elbow.  I have been trying prescription pain medication (ADVIL/ALEVE) but nothing has been working.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Intense pain in arm that vaccine was given.  Started off just sore but a few days later pain intensified and has gotten worse every day.  Now, 2 weeks later, I am having trouble lifting things and cannot sleep due to the pain.  Pain is in my shoulder, armpit and down to my elbow.  I have been trying prescription pain medication (ADVIL/ALEVE) but nothing has been working.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Chronic lymphocytic leukaemia, Histiocytosis, Insomnia, Intervertebral disc degeneration
Clinical narrative: Psoriasis, Lichen Planus, Joint Pain, Insomnia, Migraines, Degenerative Joint & Disc Disease, Indeterminate Cell Histiocytosis (ICH), Chronic Lymphocytic Leukemia. Treatments every other day for ICH using Narrow Band UvB radiation therapy.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Lichen planus, Migraine, Osteoarthritis, Psoriasis, Radiotherapy
Clinical narrative: Psoriasis, Lichen Planus, Joint Pain, Insomnia, Migraines, Degenerative Joint & Disc Disease, Indeterminate Cell Histiocytosis (ICH), Chronic Lymphocytic Leukemia. Treatments every other day for ICH using Narrow Band UvB radiation therapy.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen red injection site reaction.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Pruritus, Rash, Vaccination site swelling
Clinical narrative: Swelling and itching at vaccine site, mostly in the evening time. Itching and rash at various part of her body, relieved by BENADRYL.
Age: 84.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site mass, Injection site rash
Clinical narrative: Pt received PREVNAR 13 vaccination in (R) deltoid on 12/14/15. Pt called PCP on 12/21/2015 reporting a reaction after receiving the vaccination - developed a rash approximately the size of a tennis ball at injection site with a lump under the skin. At that time was reporting that the rash had diminished somewhat, but still persisted. Denied any other symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: This spontaneous report was received from a female patient (who is also a pharmacist) of an unknown age concerning herself via field employee. The patient's relevant medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial (lot number and dosage not reported). The patient's concomitant medication included "(unspecified) antihistamine". On an unknown date, the patient developed "hives about five inches in diameter around injection site". The patient did not seek medical attention. The patient did not had any fever or pain. The patient had used "DERMOPLAST with benzocaine which helped reduce the diameter of the hives around the injection site". The outcome of the event was recovering. The reporter did not provide any causality assessment between event and ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning an unspecified patient of unknown age and gender. No concurrent conditions or medical history were reported. On 19-APR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX with a lot # L021612 and Expiration date: 10-SEP-2016, "one vial" subcutaneous (dose and anatomical location of administration were not reported) after an initial excursion on 18-APR-2016. No concomitant therapy was provided. A previous temperature excursion of 14 F occurred for 1 hour on 18-APR-2016. Another temperature excursion of 11 F occurred for 1 hour and 30 minutes. It was reported as a Digital Data Logger. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a field employee referring to multiple unspecified patients of unknown age and gender. On multiple unspecified dates, the multiple unspecified patients were vaccinated with doses of ZOSTAVAX (strength, route, indication, Lot# and expiration date were not provided). The same multiple unspecified patients returned to the office because they had "developed shingles" on unspecified dates "within the last few weeks after the administration of ZOSTAVAX". It was also reported that the number of patients who developed shingles after the administration of ZOSTAVAX was increasing. The outcome of the adverse events was not reported. The reporter's causality was not provided. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Day after MENVEO injection, developed large area of redness, swelling, firmness around site of injection.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N.) concerning to an unspecified patient of unknown age and gender. No concurrent conditions or medical history were reported. On 12-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX with a lot # reported as L046887 and expiration date: 23-JAN-2017, (dose and anatomical location of administration were not reported). No concomitant therapy was provided. The temperature excursion was -12.3C. The time frame was 1 hour. No previous temperature excursion was reported. No data logger was called. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Musculoskeletal pain, Paraesthesia
Clinical narrative: Extreme pain in shoulder, numbness, tingling and could not move shoulder or arm.
Age: 19.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Syncope
Clinical narrative: Case number PHHY2014US132681, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 535869) website on 10 Oct 2014. This report refers to a 19-year-old male patient. Historical conditions and concomitant medication was none. He was vaccinated with MENVEO (batch number: A13064) into the right arm along with GARDASIL (batch number: H010901) and BOOSTRIX (batch number: N59M3) into the left arm intramuscularly on 06 Jun 2014. On the same day after vaccination, he fainted and fell off on exam table. The final outcome of the events was complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the company. Causality was not reported.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Muscle spasms, Throat tightness
Clinical narrative: Case number PHHY2014US132710, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 535891) website on 10 Oct 2014. This report refers to a 17-year-old female patient. Current conditions were none. She was vaccinated with MENVEO (batch number: M13067) intramuscularly on 23 Jun 2014. On 24 Jun 2014, she experienced legs cramp, tiredness and her throat closed up. She was sent to emergency room. The final outcome of the events was complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the company. Causality was not reported.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal discomfort, Cold sweat, Nausea, Syncope
Clinical narrative: Case number PHHY2014US120513 is an initial spontaneous report received from a nurse via the Vaccine Adverse Event Reporting System (VAERS reference number: 536751) website on 16 Sep 2014. This report refers to an 18 years old female patient. Her historic drug included penicillin and her current condition included drug hypersensitivity (unspecified). She had no concomitant medications. Her vaccination history included first dose of GARDASIL (other manufacturer, batch number: not reported) on 18 May 2010. She was vaccinated with meningococcal ACYW-135 vaccine (manufacturer and batch number: not reported) and second dose of GARDASIL (other manufacturer, batch number: not reported); both vaccines administered intramuscularly on 30 Jun 2014. On 01 Jul 2014, she was presented with nausea and she felt that her stomach was sick and she was clammy. On 02 Jul 2014, she fainted while taking a shower. She again fainted when getting dressed. Her body temperature was checked on an unknown date and she did not have fever and was eating and drinking well. She went to emergency room and sought medical attention, but no treatment was given for the adverse events. The outcome was reported as condition unchanged. The seriousness and causality were not reported.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Seizure, Syncope, Tremor
Clinical narrative: Case number PHHY2014US134382, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 536788) website on 10 Oct 2014. This report refers to an 18-year-old female patient. Past medical history was not reported. Concomitant medication included TUBERSOL. She was vaccinated with MENVEO (batch number: X13015) into left arm along with HAVRIX (batch number: 3535C, other manufacturer) into right arm, both intramuscularly on 15 Jul 2014. Within 5 minutes after vaccinations, she felt light headed. She sat down on a chair and within 1 minute she fainted and began to shake as if having a small seizure. The episode lasted approximately 20 seconds and she woke up. After lying down for 10-15 minutes she had fully recovered. Causality of the events was not reported. Final outcome of the events was completely recovered. These events were reported as non-serious; however the case was internally upgraded as medically significant by the company.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Case number PHHY2014US134375, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 537069) website on 10 Oct 2014. This report refers to an 11-year-old female patient. She had no known drug allergies. Concomitant medications were not reported. She was vaccinated with MENVEO (batch number: unknown) into left arm along with GARDASIL (batch number: J006850, other manufacturer) into right arm and BOOSTRIX (batch number: 4G995, other manufacturer) into left arm on 17 Jul 2014. On the same day, post vaccinations, she fainted. It was reported that she recovered immediately without intervention. The event was reported as non-serious; however the case was internally upgraded as medically significant by the MAH. Causality of the event was not reported.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Facial paralysis, Lip swelling
Clinical narrative: Case number PHHY2014US135183 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 537079) website on 10 Oct 2014. This report refers to a 17-year-old male patient. His medical history included stable asthma. Concomitant medications included EPIDUO and SOLODYN for an unspecified indication. On 02 Jul 2014, the patient was vaccinated with MENVEO (batch number: A14022) intramuscularly in the right deltoid along with GARDASIL (other manufacturer, batch number: K005083) intramuscularly in the left deltoid. On 03 Jul 2014, he experienced Bell's Palsy (left seventh cranial nerve), swollen lip and his face was drawing to the right side. The outcome of the events was unknown. The events reported as non-serious; however the case was internally upgraded as medically significant by the company. The causality of the events was not reported.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Altered state of consciousness, Seizure
Clinical narrative: Case number PHHY2014US148526 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 538152) web site on 13 Nov 2014. This report refers to a 13 year old male patient. His medical history and concomitant medication were not reported. As familial history it was reported that his 12 year old sibling experienced seizure following an unknown vaccine administration. On 24 Jul 2014, he was vaccinated with MENVEO (batch number: M12114) in left arm, HAVRIX (other manufacturer, batch number: AHAVB703BA) in left arm and GARDASIL (other manufacturer, batch number: H021608) in right arm. On the same day approximately 15 minutes after vaccinations, the patient experienced a seizure. The child quickly gained consciousness. Final outcome was reported as complete recovery. The event was reported as non-serious. However, the seriousness assessment of seizure was upgraded based on the NV key event list. Causality was not reported.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Head injury, Swelling, Syncope
Clinical narrative: Case number PHHY2014US134509, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 538864) website on 10 Oct 2014. This report refers to a 16 year old male patient. His current condition included seasonal hay fever and sublingual compound (unspecified) was used. he was vaccinated with MENVEO (batch number: unknown) intramuscular on 05 Aug 2014. On the same day he fainted and was evaluated by the doctor. Patient was standing and fell to floor injuring his head. As a result he developed lump on back of his head and required ice. Outcome of the events was unknown. Causality assessment was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the company.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Seizure, Syncope
Clinical narrative: Case number PHHY2014US148476 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 538916) website on 13 Nov 2014. This report refers to a 12 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13047) in the right arm, GARDASIL (other manufacturer, batch number: J009243) in the left arm, BOOSTRIX (other manufacturer, batch number: 4T7E4) in the left arm and VARIVAX (other manufacturer, batch number: J014960) in the right arm; all vaccines administered on 25 Jul 2014. On the same day, she experienced syncope and seizure. The final outcome was reported as complete recovery. The events were reported non-serious, but the event seizure was upgraded as medically significant based on the information available on NVS-IME list and NVx key event list and the event syncope was upgraded as medically significant based on the information available in the source documents. The causality of the event was not reported.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Malaise, Syncope, Throat irritation
Clinical narrative: Case number PHHY2014US148575 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 538997) website on 13 Nov 2014. This report refers to an 18 years old female patient. Her medical history was not reported. Her concomitant medication included PPD (tuberculin purified protein derivative). She was vaccinated with MENVEO (batch number: M14031) intramuscularly in the left arm on 04 Aug 2014. It was reported that she felt okay after vaccination and left office. She fainted outside of office and was brought back in to office to rest. She was not feeling well and she stated that her throat felt funny. She was taken to emergency room by parent. The final outcome was reported as complete recovery. The events were reported non-serious, but the event faint was upgraded as medically significant based on the information available in the source documents. The causality of the event was not reported.
Sex: F
Vaccine: MNQ
Symptoms: Hypersensitivity
Clinical narrative: Case number PHHY2014US141560, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 540338) website on 28 Oct 2014. This report refers to a female patient of unknown age. Her medical history and concomitant medication were not reported. She was vaccinated with Meningococcal ACWY vaccine INN (manufacturer and batch number unknown) on an unknown date. On an unknown date after vaccination, she experienced serious allergic reaction. According to the reporter, the patient would not be able to have a booster injection due to the reaction. The outcome of the event was condition unchanged as of 15 Aug 2014. Causality assessment was not reported. The events were reported as non-serious. Seriousness assessment of allergic reaction was upgraded based on information available in the source document.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Fall, Loss of consciousness, Musculoskeletal stiffness, Posture abnormal, Syncope
Clinical narrative: Case number PHHY2014US150288, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 540719) website on 13 Nov 2014. This report refers to a 18-year-old female patient. On 20 Aug 2014, she was vaccinated with MENVEO (batch number: M14031) intramuscularly in the left arm along with VAQTA (other manufacturer, batch number: J009441) intramuscularly in the right arm. On the same date, after vaccination she felt everything was going black. Her head slumped forward, body fell forward and she was placed in supine position. Her arms and legs stiffened then crossed and eyes closed. She was not verbally responsive for 10-12 seconds then responded and asked "what just happened". The patient visited the primary care physician on the same date for evaluation and was diagnosed with syncopal assessment of the events (syncope episode and its symptoms) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Unresponsive to stimuli, Visual impairment
Clinical narrative: Case number PHHY2014US150288, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 540719) website on 13 Nov 2014. This report refers to a 18-year-old female patient. On 20 Aug 2014, she was vaccinated with MENVEO (batch number: M14031) intramuscularly in the left arm along with VAQTA (other manufacturer, batch number: J009441) intramuscularly in the right arm. On the same date, after vaccination she felt everything was going black. Her head slumped forward, body fell forward and she was placed in supine position. Her arms and legs stiffened then crossed and eyes closed. She was not verbally responsive for 10-12 seconds then responded and asked "what just happened". The patient visited the primary care physician on the same date for evaluation and was diagnosed with syncopal assessment of the events (syncope episode and its symptoms) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Heart rate decreased, Hypotension
Clinical narrative: Case number PHHY2014US152236 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 540839) on 13 Nov 2014. This report refers to a 11 year old female patient. Her past medical history and concomitant medications were not reported. On 21 Aug 2014, she was vaccinated with MENVEO (batch number: M14030) intramuscularly into her left arm, GARDASIL (batch number: J011272) intramuscularly into her left arm and BOOSTRIX (batch number: LF444) intramuscularly into her right arm. On the same day, after the vaccination, she felt dizzy and lightheaded. The patient was instructed to lie down, was given juice and cracker. Her blood pressure was 90/55 and heart rate was 55. The physician assessed the patient prior to discharge from the clinic. The patient completely recovered from the event. The seriousness of the event was not reported but the event felt dizzy was upgraded based on the information available in the source documents. The causality of the event was not reported.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Fatigue, Hypersensitivity, Injection site discolouration, Injection site erythema, Injection site inflammation
Clinical narrative: Case number PHHY2014US144162 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 540890) website on 28 Oct 2014. This report refers to a 17 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm and varicella virus vaccine (manufacturer and batch number: not reported) subcutaneously in the right arm on 21 Aug 2014. On 23 Aug 2014, her upper right arm turned dark red, began to swell, developed erythema and inflammation and developed shingles-type vesicular lesions at the vaccination site. She had fever of 101 degrees noted with fatigue and generalized achiness. She was treated at urgent care center and was given KENALOG injection. She also started prednisone for allergic reaction and ice was applied to the site. She was also given ibuprofen and rest and fluids were ordered. The final outcome was reported as unknown. The events were reported non-serious, but was upgraded based on the information available in the source documents. The causality of the event was not reported.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site swelling, Injection site vesicles, Pain, Pyrexia
Clinical narrative: Case number PHHY2014US144162 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 540890) website on 28 Oct 2014. This report refers to a 17 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm and varicella virus vaccine (manufacturer and batch number: not reported) subcutaneously in the right arm on 21 Aug 2014. On 23 Aug 2014, her upper right arm turned dark red, began to swell, developed erythema and inflammation and developed shingles-type vesicular lesions at the vaccination site. She had fever of 101 degrees noted with fatigue and generalized achiness. She was treated at urgent care center and was given KENALOG injection. She also started prednisone for allergic reaction and ice was applied to the site. She was also given ibuprofen and rest and fluids were ordered. The final outcome was reported as unknown. The events were reported non-serious, but was upgraded based on the information available in the source documents. The causality of the event was not reported.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Swelling face, Urticaria, Vaccination complication, Viral infection
Clinical narrative: Case number PHHY2014US150437 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 541091) website on 13 Nov 2014. this report refers to a 13 years old male patient. His medical history and concomitant medications were not reported. he was vaccinated with MENVEO (batch number: M14031) intramuscularly in the left leg on 18 Aug 2014. On 23 Aug 2014, her face looked swollen to her mum. On 24 Aug 2014, she experienced hives/urticarial. She was treated with BENADRYL per oral at home in pm. She also had ZYRTEC in am. She went to emergency room and saw physician in office on 25 Aug 2014 and she was diagnosed with "virus vs reaction to MENVEO". The final outcome was reported as condition unchanged. The events were reported non-serious, but the events were upgraded as medically significant based on the information available on the source documents. The causality of the event was not reported.
Age: 60.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2014US013211 is an initial spontaneous report received from a nurse on 27 Jun 2014 with a follow up information received from a nurse on 08 Jul 2014. This report refers to a 60 year old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number: M12127) at dose of 0.5 ml intramuscularly on 17 Oct 2013. No adverse event was reported following this administration error. Follow up information received from a nurse on 08 Jul 2014: Patient demographics (initial, date of birth, gender), date of vaccination and batch number of MENVEO updated.
Age: 60.0
Sex: M
Vaccine: MNQ, MNQ, MNQ
Symptoms: Medication error, No adverse event
Clinical narrative: Case number PHEH2014US013211 is an initial spontaneous report received from a nurse on 27 Jun 2014 with a follow up information received from a nurse on 08 Jul 2014. This report refers to a 60 year old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number: M12127) at dose of 0.5 ml intramuscularly on 17 Oct 2013. No adverse event was reported following this administration error. Follow up information received from a nurse on 08 Jul 2014: Patient demographics (initial, date of birth, gender), date of vaccination and batch number of MENVEO updated.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Eye swelling, Lip swelling, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Case number PHHY2014US150440 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 541387) website on 13 Nov 2014. This report refers to an 11 year old male patient. His current condition included allergy to amoxicillin. He was vaccinated with MENVEO (batch number: A14030) and GARDASIL (other manufacturer, batch number: K005083) both in left arm on 22 Aug 2014. On 23 Aug 2014, he experienced swelling, itching and hives on left arm which lasted for 02 to 03 days. On 26 Aug 2014, he experienced lip and eye swelling. Treatment with BENADRYL caused improvement. Final outcome was complete recovery. The events were reported as non-serious. However, seriousness assessment of lip swelling and eye swelling was upgraded based on the information available in the source document. Causality was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Case number PHHY2014US150261, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 542086) website on 13 Nov 2014. This report refers to an 11-year-old male patient. Historical conditions and current illness were none. Concomitant medication was none. He was vaccinated with MENVEO (batch number: M14030) intramuscularly, along with BOOSTRIX (batch number: LF444) intramuscularly into the left arm on an unknown date. On an unknown date after vaccination, he briefly fainted. He was laid down and rested. He drank juice and water. The outcome of the event was complete recovery. The event was reported as non-serious; however the case was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 36.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Headache, Malaise, Musculoskeletal stiffness, Pyrexia, Rash
Clinical narrative: Case number PHEH2014US017179 is an initial spontaneous report received from the physician on 23 Aug 2014. This report refers to a 36 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: not reported) intramuscularly in the left deltoid on 22 Aug 2014. It was reported that after vaccination she began to experience slight fever, body aches, neck stiffness and general malaise. The outcome of the event was reported as unknown. The seriousness and causality of the events were not reported. No additional information available.
Age: 36.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Malaise, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Case number PHEH2014US017179 is an initial spontaneous report received from the physician on 23 Aug 2014. This report refers to a 36 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: not reported) intramuscularly in the left deltoid on 22 Aug 2014. It was reported that after vaccination she began to experience slight fever, body aches, neck stiffness and general malaise. The outcome of the event was reported as unknown. The seriousness and causality of the events were not reported. No additional information available.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Case number PHHY2014US151006, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543589) website on 13 Nov 2014. This report refers to a 12-year-old female patient. Historical conditions were not reported. Current illness was none. No concomitant medication was reported. She was vaccinated with MENVEO (batch number: A13047), along with GARDASIL (batch number: K001631), BOOSTRIX (batch number: 372SB) into the right arm and FLUMIST QUADRIVALENT (batch number: CH2023) on 10 Sep 2014. On 11 Sep 2014, the patient right upper arm became red, swollen, warm, and very tender. She had low grade fever and diarrhea. There was a mild improvement. On examination, she had low grade temperature. The patient right upper extremity (RUE) from mid to shoulder was very erythematous, tender, skin tight with two small blisters. The area was marked and was treated with cephalexin 500mg BID, BENADRYL PRN and MOTRIN PRN. The outcome of the events was unknown. The events were reported as non-serious; however the case was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Injection site vesicles, Injection site warmth, Pyrexia, Skin tightness
Clinical narrative: Case number PHHY2014US151006, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543589) website on 13 Nov 2014. This report refers to a 12-year-old female patient. Historical conditions were not reported. Current illness was none. No concomitant medication was reported. She was vaccinated with MENVEO (batch number: A13047), along with GARDASIL (batch number: K001631), BOOSTRIX (batch number: 372SB) into the right arm and FLUMIST QUADRIVALENT (batch number: CH2023) on 10 Sep 2014. On 11 Sep 2014, the patient right upper arm became red, swollen, warm, and very tender. She had low grade fever and diarrhea. There was a mild improvement. On examination, she had low grade temperature. The patient right upper extremity (RUE) from mid to shoulder was very erythematous, tender, skin tight with two small blisters. The area was marked and was treated with cephalexin 500mg BID, BENADRYL PRN and MOTRIN PRN. The outcome of the events was unknown. The events were reported as non-serious; however the case was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 11.0
Sex: F
Vaccine: HPV2, MNQ, TDAP
Symptoms: Dizziness, Headache, Pallor, Syncope, X-ray
Clinical narrative: Case number PHHY2014US151031, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543632) website on 13 Nov 2014. This report refers to an 11-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A13017) intramuscularly into left arm on 20 May 2014. On the same day, she was also vaccinated with CERVARIX (batch number: AHPVA174RT, other manufacturer) into left arm and BOOSTRIX (batch number: N3BE2, other manufacturer) into right arm, both intramuscularly. On the same day, after vaccinations, she became pale, dizzy and eventually fainted. Later she complained of a headache. She went to emergency room due to these events. She was given intravenous fluids (IVFs) via keep vein open (KVO). She underwent X-ray (results not reported). Outcome of the events was reported as recovered. These events were reported as non-serious. Causality of the events was not reported. Seriousness assessment of pale, dizzy, faint was upgraded based on information in source document.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Feeling cold, Pallor, Syncope
Clinical narrative: Case number PHHY2014US151058, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543634) website on 13 Nov 2014. This report refers to a 17-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A11072) into left arm on 28 Mar 2014. On the same day, after vaccination, her skin became pale, cold, felt dizzy and eventually fainted. She went to emergency room due to these events. Outcome of the events was reported as recovered. These events were reported as non-serious. Causality of the events was not reported. Seriousness assessment of pale, cold, dizzy and faint was upgraded based on information in source document.