chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to a 61 year old male patient. Patient had Bell's palsy 20 years ago. Patient had no drug reactions and allergies. On 22-JUL-2014 the patient was vaccinated with ZOSTAVAX (lot#, dose, route not reported) at his employers Health Fair in left arm for Prevention for "Shingles". No concomitant medications were reported. The patient stated that approximately 72 hours later (On 25-JUL-2014) he developed an itchy, burning patch on the left side of his rib cage that progressed to his back over a few days. The patient visited his physician who determined it was a case of "Shingles". The physician prescribed an anti-viral medication (brand, manufacturer, & dose unspecified). There was no product quality complaint. The patient sought medical attention by office visit. No lab diagnostics studies were performed. The outcome of shingles was reported as recovering/resolving. The causality is unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a respiratory therapist refers to a 26 unspecified patients, age and gender were unknown. Medical history was not reported. The respiratory therapist informed that between 01-FEB-2014 through 31-MAY-2014 the patients were vaccinated with PNEUMOVAX 23 (route, strength and dosage were not reported), which was improperly stored. The possible lots involved: H002280 expiration date 16-JUL-2014; T004196, expiration date: 06-DEC-2014; T013345, expiration date: 11-JAN-2015; and T015866, expiration date: 25-FEB2015. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: This spontaneous report as received from a 64 year old female patient with allergy to penicillin and allergy to KEFLEX. The patient's medical history included chicken pox virus in the past (date not specified). On approximately 14-JUL-2014, reported as about 4 weeks ago, the patient was vaccinated with a dose of ZOSTAVAX single injection in her arm (exact route not specified). Concomitant medications were not specified. On approximately 14-JUL-2014, reported as about 4 weeks ago, the patient experienced injection site reaction in the form of a rash and break out in hives. The patient sought medical attention and received treatment (unspecified corticosteroids, route not specified) from a dermatologist. No lab diagnostics studies were performed. The outcome of injection site reaction in the form of a rash and breaking out in hives was reported as fully recovered on 11-AUG-2014. The relatedness between and injection site reaction in the form of a rash and breaking out in hives and ZOSTAVAX was not reported. Additional information is not expected.
Age: 14.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Off label use
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 14 year old patient of unknown gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On 05-AUG-2014, at the age of 14 years old, the patient was vaccinated with first adult dose of VAQTA 50/1.0 U/ml (site and route of injection, lot# and expiration date not reported). No adverse symptoms were reported. Additional information has been nrequested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. It was reported that unknown number of doses of VARIVAX (lot number: J012328, expiration date 02-OCT-2015) were exposed to temperature of -14C for a few hours and then -10.2C for less than 1 hour. It was reported that the patient identifiers or dates of administration available at this time. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. It was reported that unknown number of doses of VARIVAX (lot number: J013900, expiration date 30-OCT-2015) were exposed to temperature of -14C  for a few hours and then -10.2C for less than 1 hour. It was reported that the doses might had been administered to the patient subcutaneously, 0.5ml. No adverse effect was reported. The nurse did not have patient identifiers or dates of administration available at this time. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients (unknown age and gender). On an unknown date, the patients were vaccinated with LIQUID PEDVAXHIB (dose, route of administration and lot number were not reported) GARDASIL which were improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients (unknown age and gender). On an unknown date, the patients were vaccinated with GARDASIL (dose, route of administration and lot number were not reported) or PEDVAXHIB which were improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information has bee requested.
Age: 22.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 22 year old patient of unknown gender. On 06-AUG-2014 the patient was mistakenly vaccinated with a pediatric dose of VAQTA (route, dose and lot# not reported) instead of an adult dose of VAQTA. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of PNEUMOVAX23 (lot# not reported) that were stored in a refrigerator that was below the recommended storage temperature for the "past month" July 2014. At the time of the report, firma data were not available to provide a definite stability assessment, but informed that the vaccine was most likely not supported. There were any adverse experiences. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a female patient, age unknown. On an unknown date the patient was vaccinated with M-M-R II. One an unknown date the patient had "titers" drawn and showed "negative for mumps" after receiving MMR II. When further information was requested the physician placed the field representative on the line. The field representative was asked all questions in the AE report. The field representative had minimal information therefore most drop down fields are unspecified by reporter. No further information was provided. On an unknown date the patient had "titers" drawn and showed "negative for mumps" after receiving MMR II. The outcome of the "titers" drawn and showed "negative for mumps" after receiving MMR II is unknown. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare Worker refers to a patient of unknown age and gender. On 08-AUG-2014 the patient was vaccinated with M-M-R II injection (dose: 0.5 ml, lot number h014647, expiration date 06-AUG-2014) subcutaneous. There was no concomitant medication reported. The healthcare worker reported that the patient received an expired dose of M-M-R II. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her unknown age daughter who is the patient and also has a twin sister. Information regarding concurrent conditions and medical history was not provided. Approximately 1 year and 2 months ago, on an unknown date in June 2013 the patient was vaccinated with the first dose of GARDASIL (lot#, dose and route were not provided). No concomitant medications were reported. And at the time of the report the patient would like to receive the second dose. No adverse symptoms reported. There was no product quality complaint. This case is linked to SR# 1-12068244292 (Marrs# 1408USA002263), which has adverse information for the other twin. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown gender and unknown age. The patient was vaccinated with a first dose of VARIVAX (Merck) injection (lot#, dose and route not provided) on 14-MAY-2014 and a second dose of VARIVAX (Merck) injection (lot#, dose and route not provided) on 21-JUL-2014. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Current conditions and relevant medical history were not reported. It was reported that in June 2013 the patient was vaccinated with the first dose of GARDASIL (injection, strength, dose, route, anatomical location, lot # and expiration date not reported). In November 2013, the patient was vaccinated with a second dose of GARDASIL (injection, strength, dose, route, anatomical location, lot # and expiration date not reported). It was reported that the patient had not been vaccination at the moment of the report with the third dose of GARDASIL. No adverse event reported. Additional information is not expected because the reporter did not consent for further follow up.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Arthralgia, Asthenia, Blood iron, Body temperature increased
Clinical narrative: Starting on 8/5 pt experienced joint pain, weakness, aching, fatigue, abdominal pain, headaches. These symptoms lasted until 8/5-8/11. Had one more severe episode of epistaxis which she has weekly. Also had 6 days (six) of temp of 100. Concern of extreme fatigue this week.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Condition aggravated, Epistaxis, Fatigue, Full blood count, Headache
Clinical narrative: Starting on 8/5 pt experienced joint pain, weakness, aching, fatigue, abdominal pain, headaches. These symptoms lasted until 8/5-8/11. Had one more severe episode of epistaxis which she has weekly. Also had 6 days (six) of temp of 100. Concern of extreme fatigue this week.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pain, Serum ferritin, Vitamin B12
Clinical narrative: Starting on 8/5 pt experienced joint pain, weakness, aching, fatigue, abdominal pain, headaches. These symptoms lasted until 8/5-8/11. Had one more severe episode of epistaxis which she has weekly. Also had 6 days (six) of temp of 100. Concern of extreme fatigue this week.
Age: 0.89
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site warmth, Irritability, Lethargy, Pyrexia
Clinical narrative: Patient developed a fever of 103, lethargy, increased fussiness, pinpoint red rash all over his body, and site became hard and warm to touch. Mom did not seek medical attention - mom called office on 8/8/14 at 10:05 am.
Age: 0.89
Sex: M
Vaccine: DTAP
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Patient developed a fever of 103, lethargy, increased fussiness, pinpoint red rash all over his body, and site became hard and warm to touch. Mom did not seek medical attention - mom called office on 8/8/14 at 10:05 am.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Breast enlargement, Cellulitis, Infection, Inflammation, Injection site anaesthesia
Clinical narrative: TB Skin Test Chronin flammatory, pain, swelling and softer toxic infection was traveling throughout my body auxillary lymph-adenopathy in my left breast have enlarged, phlebitis, cellulites are in the injection on 7-29-2014 the Doctor insert a syringe in my arm where I was inject TB Skin test. TDAP swelling shoulders numbness.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Lymphadenopathy, Pain, Phlebitis, Swelling
Clinical narrative: TB Skin Test Chronin flammatory, pain, swelling and softer toxic infection was traveling throughout my body auxillary lymph-adenopathy in my left breast have enlarged, phlebitis, cellulites are in the injection on 7-29-2014 the Doctor insert a syringe in my arm where I was inject TB Skin test. TDAP swelling shoulders numbness.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left vastus lateralis red and warm to the touch at site of administration. Advised by Dr to put cool compress and Ibuprofen if fever presents. Mom advsied to call clinic if symptoms worsen or do not imiprove.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Cold sweat, Hyperhidrosis, Malaise, Musculoskeletal stiffness, Pallor
Clinical narrative: Approx. 5 min after vaccination pt stated she wasn't feeling well. Her body started to shake; stiffen slightly. She fainted (just briefly then opened her eyes. She was sweating, her skin was cold and clammy, skin color was pale. I had pt lie down, gave her water to drink. Also cold wash cloth of her forhead. Doctor came in to check her. She fully recovered after approx 25 min.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope, Tremor
Clinical narrative: Approx. 5 min after vaccination pt stated she wasn't feeling well. Her body started to shake; stiffen slightly. She fainted (just briefly then opened her eyes. She was sweating, her skin was cold and clammy, skin color was pale. I had pt lie down, gave her water to drink. Also cold wash cloth of her forhead. Doctor came in to check her. She fully recovered after approx 25 min.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Pyrexia, Rash
Clinical narrative: Fever, rash and fatigue. Triamcinolone BID, Diphenhydramine.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Local swelling, Pain
Clinical narrative: Body ache, hand swollen from shoulder to elbow.
Age: 28.0
Sex: M
Vaccine: HEPA, IPV, TYP, YF
Symptoms: Dysstasia, Hypotonia, Loss of consciousness
Clinical narrative: Pt received multiple shots listed below and passed out when yellow fever administered. Pt tried to stand up and limply went to ground. Held as best I could and got pulse. called tech to get 911. He woke up and asked not to call. Gave OJ after he sat up. Pt left store about 40 minutes later refused to go with paramedics they took vitals.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed warmth, swelling and redness to injection site. Evaluated on 8/8/2014 and administered clindamycin HCl 300mg TID x 7 days.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Nausea
Clinical narrative: Client stated he felt dizzy after vaccines. Stated he was dizzy all day while sitting or getting up too fast. Stated he also felt a little nauseous, but did not feel like he was going to emesis. Reports he felt fine next day and since then.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Abnormal behaviour, Decreased appetite, Dizziness postural, Electrocardiogram normal, Headache
Clinical narrative: 10 days of headache. Dizziness or lightheaded when standing. Decreased poor appetite. Weight loss. Subdued behavior.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Weight decreased
Clinical narrative: 10 days of headache. Dizziness or lightheaded when standing. Decreased poor appetite. Weight loss. Subdued behavior.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Injection site pain, Nausea, Retching
Clinical narrative: Received ADACEL (Tdap) on 8/11/14 at 1:30 pm on (L) deltoid. Woke on 8/12/14 at 4 am with headache and nausea, dry heaves and sli. diarrhea. Injection side sli. tender to touch without swelling/redness.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Condition aggravated, Dry skin, Eczema, Swelling face
Clinical narrative: Mother reports that 2 hours after administration child's face was swollen and she was taken to ER. She was given prednisone at ER, and recovered. By 8/11/14 the swelling had "pretty much resolved". She had a PPD placed on 8/8/14 as well and returned for PPD read on 8/11/14 and mom said she was much better. She has eczema with dry patches on face and neck.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever. Large area approximately size 1/2 dollar of redness, swelling, induration, excruciating pain to left upper arm - site of injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Very sore. Very swollen. Itching. Bright red.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury
Clinical narrative: Pt fell from standing after receiving HPV vaccine. No LOC. C/o hit back of head. Pt was laid down after fall and given juice. Monitored for 20 min in office. No visible head injury or change in consciousness. Able to walk out of office.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Expired drug administered
Clinical narrative: Expired MMR - expired 8/3/14 - given 8/6/14.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Hyperhidrosis, Hyperventilation, Pallor, Syncope
Clinical narrative: Client fainted at the checkout counter. Her mother laid her to the floor. She regained conscious immediately without intervention. Client was pale, diaphoretic, hyperventilation.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site warmth
Clinical narrative: Patient presented with redness to site of pneumococcal vaccine - 4cm area of redness slight warmth. Likely allergic rxn.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Pain, erythema. Diphenhydramine.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: Patient received hepatitis B vaccine with no information as to where/exactly when; no manufacturer information, no other information. He came with arm soreness 2 weeks after injection and was told not to get the third injection.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Tachycardia
Clinical narrative: Dizziness and tachycardia.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiforme.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Oedema, Urticaria
Clinical narrative: Edema/hives. Methylprednisolone 125 mg once.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Local swelling
Clinical narrative: Swelling of area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: RA red, warm to touch, hard under skin. Redness is 7 1/2 cm wide by 9 1/2 cm long.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria
Clinical narrative: Patient developed a single hive adjacent to MMR-V vaccine injection 1 minute after injection. Responded to cold pack. No progression after 15-20 minutes. No other hives, no swelling, no SOB.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Pruritus, Rash
Clinical narrative: Patient received the meningococcal vaccine on Tuesday 8/5/14. On Thursday he states he noticed his arms itching. A rash was on his arms and throughout the day spread to his trunk, back and legs.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Pruritus generalised
Clinical narrative: Patient received the meningococcal vaccine on Tuesday 8/5/14. On Thursday he states he noticed his arms itching. A rash was on his arms and throughout the day spread to his trunk, back and legs.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Received vaccines 8/1 at 11:27 am; fever of 103.9 degrees at 10 pm with 1 episode nausea and vomiting; temp 104 degrees at 1 am 8/2. Pt received 160 mg APAP and 150 mg ibuprofen. Symptoms resolved by 8/3.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Cough, Eye discharge, Eye swelling, Eyelid margin crusting
Clinical narrative: Case number PHHY2013US147180, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 508700) website on 16 Dec 2013 and a follow up information was received from the Vaccine Adverse Event Reporting System (VAERS reference number: 508700) website on 24 Jul 2014 and a follow up information received from the quality assurance department on 31 Jul 2014. This report refers to a 67-year-old female patient. Her medical history included high blood pressure. Concomitant drug include COZAAR. She was vaccinated with FLUVIRIN (batch number: not reported) in the left arm on 15 Oct 2013. On the same date, after vaccination the patient experienced deep chest cough that hurt in the chest and resulted in sore throat. Her eyes turned red, swollen and was secreting mucus. The event cough lasted approximately 5 hours. Her eyes were crusted the next morning and still swollen. It was reported that her eyes were not swollen after 3 days, but stuffy for 4 days turning into drainage on the fifth day. The outcome of the events was reported as recovered. The causality of the events was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the MAH. Upon follow up receipt on 31 Jul 2014, the quality assurance department confirmed that the initially reported batch number, U4762BA was not a valid FLUVIRIN batch number and hence a batch investigation could not be performed. Follow up information was received from the Vaccine Adverse Event Reporting System (VAERS reference number: 508700) website on 24 Jul 2014: Updated vaccine name, and batch number. Follow up information received from the quality assurance department on 31 Jul 2014: The batch number U4762BA was not a valid FLUVIRIN batch number.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Case number PHHY2013US147180, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 508700) website on 16 Dec 2013 and a follow up information was received from the Vaccine Adverse Event Reporting System (VAERS reference number: 508700) website on 24 Jul 2014 and a follow up information received from the quality assurance department on 31 Jul 2014. This report refers to a 67-year-old female patient. Her medical history included high blood pressure. Concomitant drug include COZAAR. She was vaccinated with FLUVIRIN (batch number: not reported) in the left arm on 15 Oct 2013. On the same date, after vaccination the patient experienced deep chest cough that hurt in the chest and resulted in sore throat. Her eyes turned red, swollen and was secreting mucus. The event cough lasted approximately 5 hours. Her eyes were crusted the next morning and still swollen. It was reported that her eyes were not swollen after 3 days, but stuffy for 4 days turning into drainage on the fifth day. The outcome of the events was reported as recovered. The causality of the events was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the MAH. Upon follow up receipt on 31 Jul 2014, the quality assurance department confirmed that the initially reported batch number, U4762BA was not a valid FLUVIRIN batch number and hence a batch investigation could not be performed. Follow up information was received from the Vaccine Adverse Event Reporting System (VAERS reference number: 508700) website on 24 Jul 2014: Updated vaccine name, and batch number. Follow up information received from the quality assurance department on 31 Jul 2014: The batch number U4762BA was not a valid FLUVIRIN batch number.
Age: 11.0
Sex: F
Vaccine: MNQ, PNC13
Symptoms: Amnesia, Arthralgia, Back pain, Blood test, Computerised tomogram head
Clinical narrative: Case number PHHY2014US006380 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 515472) website on 20 Jan 2014 with a follow up information received from the quality assurance department (reference number: 278392) on 06 Feb 2014 and a follow up report from the vaccine adverse event reporting system received on 24 Jul 2014 and a follow up information received from the quality assurance department on 31 Jul 2014. This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: not reported) into left arm on 24 Aug 2013. On the same day, she was also vaccinated with PREVNAR 13 (other manufacturer and batch number: F75398) into right arm. On the same day, post vaccinations, she experienced flu like symptoms with no fever for 3 days. She also experienced headaches and for which she took TYLENOL. Then one month later she was on crutches with her knee buckling and low back pain. After 3 weeks it started to spread to her left knee, ankles and hips. She could not walk or stand on her own, so doctor send her to hospital for tests where she stayed four days. She had severe joint pain from head to toe with headaches. It was reported that she had mycoplasma pneumonia and she was sent her home with a Z-PAK. She went home in a wheel chair. Two weeks later she went back to hospital for a headache which lasted for 6 days. She had CT (computerized tomogram) scan of the brain, a lumbar puncture, blood work 6 times, full spine MRI (magnetic resonance imaging) and brain MRI. Brain MRI was found to be normal so she was sent home again. She could not go to school due to lack of concentration, memory loss and just overall did not feel well, so now she was getting home instruction. The patient had not walked in seven weeks and was still in a lot of pain. Final outcome of the events was reported as condition unchanged. The events reported as serious (hospitalization for 7 days). The causality of the events was not reported. Upon follow up receipt from QA department on 31 Jul 2014, it was reported that the initially reported batch number, 024011 was not a valid MENVEO batch number and hence a QA investigation would not be performed. Follow up information received from the quality assurance department (reference number: 278392) on 06 Feb 2014: Updated expiry date, event (expired vaccine administered) and QA comments. Follow up report from the vaccine adverse event reporting system received 24 Jul 2014: Changed product coding from MENIVACT to MENVEO as reported. Updated seriousness of the events. Follow up information received from quality assurance department on 31 Jul 2014: QA department confirmed that the initially reported batch number was not valid for MENVEO and hence no investigation would be performed.
Age: 11.0
Sex: F
Vaccine: MNQ, PNC13
Symptoms: Disturbance in attention, Dysstasia, Expired drug administered, Gait disturbance, Headache
Clinical narrative: Case number PHHY2014US006380 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 515472) website on 20 Jan 2014 with a follow up information received from the quality assurance department (reference number: 278392) on 06 Feb 2014 and a follow up report from the vaccine adverse event reporting system received on 24 Jul 2014 and a follow up information received from the quality assurance department on 31 Jul 2014. This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: not reported) into left arm on 24 Aug 2013. On the same day, she was also vaccinated with PREVNAR 13 (other manufacturer and batch number: F75398) into right arm. On the same day, post vaccinations, she experienced flu like symptoms with no fever for 3 days. She also experienced headaches and for which she took TYLENOL. Then one month later she was on crutches with her knee buckling and low back pain. After 3 weeks it started to spread to her left knee, ankles and hips. She could not walk or stand on her own, so doctor send her to hospital for tests where she stayed four days. She had severe joint pain from head to toe with headaches. It was reported that she had mycoplasma pneumonia and she was sent her home with a Z-PAK. She went home in a wheel chair. Two weeks later she went back to hospital for a headache which lasted for 6 days. She had CT (computerized tomogram) scan of the brain, a lumbar puncture, blood work 6 times, full spine MRI (magnetic resonance imaging) and brain MRI. Brain MRI was found to be normal so she was sent home again. She could not go to school due to lack of concentration, memory loss and just overall did not feel well, so now she was getting home instruction. The patient had not walked in seven weeks and was still in a lot of pain. Final outcome of the events was reported as condition unchanged. The events reported as serious (hospitalization for 7 days). The causality of the events was not reported. Upon follow up receipt from QA department on 31 Jul 2014, it was reported that the initially reported batch number, 024011 was not a valid MENVEO batch number and hence a QA investigation would not be performed. Follow up information received from the quality assurance department (reference number: 278392) on 06 Feb 2014: Updated expiry date, event (expired vaccine administered) and QA comments. Follow up report from the vaccine adverse event reporting system received 24 Jul 2014: Changed product coding from MENIVACT to MENVEO as reported. Updated seriousness of the events. Follow up information received from quality assurance department on 31 Jul 2014: QA department confirmed that the initially reported batch number was not valid for MENVEO and hence no investigation would be performed.
Age: 11.0
Sex: F
Vaccine: MNQ, PNC13
Symptoms: Influenza like illness, Joint instability, Lumbar puncture, Malaise, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Case number PHHY2014US006380 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 515472) website on 20 Jan 2014 with a follow up information received from the quality assurance department (reference number: 278392) on 06 Feb 2014 and a follow up report from the vaccine adverse event reporting system received on 24 Jul 2014 and a follow up information received from the quality assurance department on 31 Jul 2014. This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: not reported) into left arm on 24 Aug 2013. On the same day, she was also vaccinated with PREVNAR 13 (other manufacturer and batch number: F75398) into right arm. On the same day, post vaccinations, she experienced flu like symptoms with no fever for 3 days. She also experienced headaches and for which she took TYLENOL. Then one month later she was on crutches with her knee buckling and low back pain. After 3 weeks it started to spread to her left knee, ankles and hips. She could not walk or stand on her own, so doctor send her to hospital for tests where she stayed four days. She had severe joint pain from head to toe with headaches. It was reported that she had mycoplasma pneumonia and she was sent her home with a Z-PAK. She went home in a wheel chair. Two weeks later she went back to hospital for a headache which lasted for 6 days. She had CT (computerized tomogram) scan of the brain, a lumbar puncture, blood work 6 times, full spine MRI (magnetic resonance imaging) and brain MRI. Brain MRI was found to be normal so she was sent home again. She could not go to school due to lack of concentration, memory loss and just overall did not feel well, so now she was getting home instruction. The patient had not walked in seven weeks and was still in a lot of pain. Final outcome of the events was reported as condition unchanged. The events reported as serious (hospitalization for 7 days). The causality of the events was not reported. Upon follow up receipt from QA department on 31 Jul 2014, it was reported that the initially reported batch number, 024011 was not a valid MENVEO batch number and hence a QA investigation would not be performed. Follow up information received from the quality assurance department (reference number: 278392) on 06 Feb 2014: Updated expiry date, event (expired vaccine administered) and QA comments. Follow up report from the vaccine adverse event reporting system received 24 Jul 2014: Changed product coding from MENIVACT to MENVEO as reported. Updated seriousness of the events. Follow up information received from quality assurance department on 31 Jul 2014: QA department confirmed that the initially reported batch number was not valid for MENVEO and hence no investigation would be performed.
Age: 11.0
Sex: F
Vaccine: MNQ, PNC13
Symptoms: Nuclear magnetic resonance imaging spinal, Pneumonia mycoplasmal, Walking aid user
Clinical narrative: Case number PHHY2014US006380 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 515472) website on 20 Jan 2014 with a follow up information received from the quality assurance department (reference number: 278392) on 06 Feb 2014 and a follow up report from the vaccine adverse event reporting system received on 24 Jul 2014 and a follow up information received from the quality assurance department on 31 Jul 2014. This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: not reported) into left arm on 24 Aug 2013. On the same day, she was also vaccinated with PREVNAR 13 (other manufacturer and batch number: F75398) into right arm. On the same day, post vaccinations, she experienced flu like symptoms with no fever for 3 days. She also experienced headaches and for which she took TYLENOL. Then one month later she was on crutches with her knee buckling and low back pain. After 3 weeks it started to spread to her left knee, ankles and hips. She could not walk or stand on her own, so doctor send her to hospital for tests where she stayed four days. She had severe joint pain from head to toe with headaches. It was reported that she had mycoplasma pneumonia and she was sent her home with a Z-PAK. She went home in a wheel chair. Two weeks later she went back to hospital for a headache which lasted for 6 days. She had CT (computerized tomogram) scan of the brain, a lumbar puncture, blood work 6 times, full spine MRI (magnetic resonance imaging) and brain MRI. Brain MRI was found to be normal so she was sent home again. She could not go to school due to lack of concentration, memory loss and just overall did not feel well, so now she was getting home instruction. The patient had not walked in seven weeks and was still in a lot of pain. Final outcome of the events was reported as condition unchanged. The events reported as serious (hospitalization for 7 days). The causality of the events was not reported. Upon follow up receipt from QA department on 31 Jul 2014, it was reported that the initially reported batch number, 024011 was not a valid MENVEO batch number and hence a QA investigation would not be performed. Follow up information received from the quality assurance department (reference number: 278392) on 06 Feb 2014: Updated expiry date, event (expired vaccine administered) and QA comments. Follow up report from the vaccine adverse event reporting system received 24 Jul 2014: Changed product coding from MENIVACT to MENVEO as reported. Updated seriousness of the events. Follow up information received from quality assurance department on 31 Jul 2014: QA department confirmed that the initially reported batch number was not valid for MENVEO and hence no investigation would be performed.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Cardio-respiratory arrest, Death
Clinical narrative: This spontaneous report was received from a company representative refers to a 12 year old female patient. The company representative read an article dated 08-AUG-2014, regarding the 12 year old female patient which stated that on 30-JUL-2014, the patient visited the doctor's office during a routine visit and received a HPV vaccination. The article made a mention that the patient possibly received GARDASIL. The patient felt sleepy after receiving the vaccine. Later in the day the patient was found on the floor face down, she had vomited, felt hot, not breathing and had no pulse. The article stated that the patient was taken to the hospital (name and demographics unknown) and was pronounced dead on 30-JUL-2014. The cause of death was unknown. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Death, Fall, Pulse absent, Respiratory arrest, Skin warm
Clinical narrative: This spontaneous report was received from a company representative refers to a 12 year old female patient. The company representative read an article dated 08-AUG-2014, regarding the 12 year old female patient which stated that on 30-JUL-2014, the patient visited the doctor's office during a routine visit and received a HPV vaccination. The article made a mention that the patient possibly received GARDASIL. The patient felt sleepy after receiving the vaccine. Later in the day the patient was found on the floor face down, she had vomited, felt hot, not breathing and had no pulse. The article stated that the patient was taken to the hospital (name and demographics unknown) and was pronounced dead on 30-JUL-2014. The cause of death was unknown. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Somnolence, Vomiting
Clinical narrative: This spontaneous report was received from a company representative refers to a 12 year old female patient. The company representative read an article dated 08-AUG-2014, regarding the 12 year old female patient which stated that on 30-JUL-2014, the patient visited the doctor's office during a routine visit and received a HPV vaccination. The article made a mention that the patient possibly received GARDASIL. The patient felt sleepy after receiving the vaccine. Later in the day the patient was found on the floor face down, she had vomited, felt hot, not breathing and had no pulse. The article stated that the patient was taken to the hospital (name and demographics unknown) and was pronounced dead on 30-JUL-2014. The cause of death was unknown. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from a company representative refers to a 12 year old female patient. The company representative read an article dated 08-AUG-2014, regarding the 12 year old female patient which stated that on 30-JUL-2014, the patient visited the doctor's office during a routine visit and received a HPV vaccination. The article made a mention that the patient possibly received GARDASIL. The patient felt sleepy after receiving the vaccine. Later in the day the patient was found on the floor face down, she had vomited, felt hot, not breathing and had no pulse. The article stated that the patient was taken to the hospital (name and demographics unknown) and was pronounced dead on 30-JUL-2014. The cause of death was unknown. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Autopsy, Death, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a company representative refers to a 12 year old female patient. The company representative read an article dated 08-AUG-2014, regarding the 12 year old female patient which stated that on 30-JUL-2014, the patient visited the doctor's office during a routine visit and received a HPV vaccination. The article made a mention that the patient possibly received GARDASIL. The patient felt sleepy after receiving the vaccine. Later in the day the patient was found on the floor face down, she had vomited, felt hot, not breathing and had no pulse. The article stated that the patient was taken to the hospital (name and demographics unknown) and was pronounced dead on 30-JUL-2014. The cause of death was unknown. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPVX, HPV4, HPV4
Symptoms: Death, Hypersomnia, Loss of consciousness, Resuscitation, Somnolence
Clinical narrative: This spontaneous report was received from a company representative refers to a 12 year old female patient. The company representative read an article dated 08-AUG-2014, regarding the 12 year old female patient which stated that on 30-JUL-2014, the patient visited the doctor's office during a routine visit and received a HPV vaccination. The article made a mention that the patient possibly received GARDASIL. The patient felt sleepy after receiving the vaccine. Later in the day the patient was found on the floor face down, she had vomited, felt hot, not breathing and had no pulse. The article stated that the patient was taken to the hospital (name and demographics unknown) and was pronounced dead on 30-JUL-2014. The cause of death was unknown. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Burning sensation, Pruritus
Clinical narrative: It caused a burning, "athletes foot type" sensation in between all of my toes on both my feet. It also was along the outsole side of both feet. The burning and itching subsided by the fourth day.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema
Clinical narrative: Erythema L deltoid area from Menactra IM 20 cm tip of clavicle to outer distal upper arm lateral aspect.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Pain at injection site, nausea, headache, aching in muscles and joints, fever, chills, sweats. Time course 36 hours, home remedy and sleep treatment.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Pain at injection site, nausea, headache, aching in muscles and joints, fever, chills, sweats. Time course 36 hours, home remedy and sleep treatment.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Amnesia, Eye movement disorder, Headache, Loss of consciousness, Malaise
Clinical narrative: Patient felt sick, turned white. I laid him back he passed out with eyes open. Eyes began to roll to the back, head turned to the left, arms went to the face with hands curled, moaning occurred, head turned to the right, hands curled and pressed against face. This lasted about two minutes. Patient regained consciousness with loss of memory as to what happened right before. Juice and crackers were administered by doctors. It took a good 10 or more minutes to regain facial color. A headache persisted after the event and into the night. Seemed to be syncope with tonic movements.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Moaning, Pallor, Syncope, Tonic clonic movements
Clinical narrative: Patient felt sick, turned white. I laid him back he passed out with eyes open. Eyes began to roll to the back, head turned to the left, arms went to the face with hands curled, moaning occurred, head turned to the right, hands curled and pressed against face. This lasted about two minutes. Patient regained consciousness with loss of memory as to what happened right before. Juice and crackers were administered by doctors. It took a good 10 or more minutes to regain facial color. A headache persisted after the event and into the night. Seemed to be syncope with tonic movements.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Erythema, Local swelling, Urticaria
Clinical narrative: Left lower leg below the knee became extremely red and swollen with hives which lasted 30 minutes.  No other symptoms noted.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Vomiting
Clinical narrative: Vomiting, Diarrhea, Chills, Joint pain, Tiredness.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Barium enema, Computerised tomogram abdomen abnormal, Crying, Enema administration, Intussusception
Clinical narrative: Presented to E.R. on 7/26 evening with hx of crying, irritability and bilious vomiting 15 x's approx. 10-12 hrs. Workup/CT abd revealed intussusception 5-6cm. A.M. of 7/27 pt. was transferred to hosp. via ambulance. Barium enema performed and intussusception resolved without surgery. D/c'd home on 7/28/14.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Vomiting
Clinical narrative: Presented to E.R. on 7/26 evening with hx of crying, irritability and bilious vomiting 15 x's approx. 10-12 hrs. Workup/CT abd revealed intussusception 5-6cm. A.M. of 7/27 pt. was transferred to hosp. via ambulance. Barium enema performed and intussusception resolved without surgery. D/c'd home on 7/28/14.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On 23-JUL-2014, the patient was vaccinated with improperly stored M-M-R II (dose, frequency, route not reported). Product lot# J009382, Expiry date: 08-AUG-2015. No adverse symptoms were reported. There was no product quality complaint involved. The outcome of the event was unknown. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Injected limb mobility decreased, Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Itching started first, I expected soreness it was a little sore, next morning arm was red a slightly swollen at the injection site, more discomfort (all things I expected), next day swelling tripled in size, hot to the touch, could not longer move my arm, itching out of control, saw doctor on this day.