chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information was received from a licensed practical nurse regarding a female patient, age unknown, who received an expired dose of M-M-R II on 08-APR-2014, 0.5 ml subcutaneously (lot #0426AE, expiration date 27-FEB-2014). No symptoms reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to a 12 year old female patient. On 23-NOV-2013 the patient was vaccinated with GARDASIL (lot # and expired date not provided). No concomitant medication was reported. Second dose was administered on 23-AUG-2031 and the third dose on 23-NOV-2013. No adverse effect reported. There was no product quality complaint. Outcome of the event was unknown. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash erythematous, Rash generalised, Rash pruritic, Streptococcus test negative
Clinical narrative: Itchy rash all over face and body, occurred for 5+ days. Little red bumps.
Age: 1.52
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Bladder catheterisation, Chest X-ray, Convulsion, Culture urine, Dyspnoea
Clinical narrative: Seizure, difficulty breathing and a fever at home. Squad took to local hospital unable to control seizure. Life flighted to hospital. Fever lasted 3 days. Rash on buttock lasted 4-5 days. Diagnosed with Roseola on 4/25/2014.
Age: 1.52
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pyrexia, Rash, Roseola, Urine analysis
Clinical narrative: Seizure, difficulty breathing and a fever at home. Squad took to local hospital unable to control seizure. Life flighted to hospital. Fever lasted 3 days. Rash on buttock lasted 4-5 days. Diagnosed with Roseola on 4/25/2014.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Sunday 4/20 presented with a slightly raised area with an area of redness smaller than the size of palm. Patient was told to watch area for any signs of worsening symptoms and evaluate on 4/21. On 4/21 patient went to Urgent Care even though symptoms had not gotten worse. She will also follow up with primary doctor. On prednisone and BENADRYL.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Asthenia, Headache, Nausea, Syncope, Vomiting
Clinical narrative: Fainted after vaccination, after fainting - exhibited headache, weakness, nausea, vomiting. Was monitored at office for 45 minutes, then sent via ambulance to hospital.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Red, sore, itching for 5 days after getting vaccine.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Rash over (R) shoulder x1 day, erythematous, urticarial. No fever.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Erythema, Induration, Pruritus, Pyrexia
Clinical narrative: REDNESS, SWELLING AREA ABOUT SIZE 2"X4", ITCHING, FEVER. ON 4/25/14 LARGER RED AREA WITH SORENESS UNDER ARM ALSO. HARD AND HOT TO TOUCH. CONTINUED SORENESS.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: REDNESS, SWELLING AREA ABOUT SIZE 2"X4", ITCHING, FEVER. ON 4/25/14 LARGER RED AREA WITH SORENESS UNDER ARM ALSO. HARD AND HOT TO TOUCH. CONTINUED SORENESS.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: REDNESS, SWELLING AREA ABOUT SIZE 2"X4", ITCHING, FEVER. ON 4/25/14 LARGER RED AREA WITH SORENESS UNDER ARM ALSO. HARD AND HOT TO TOUCH. CONTINUED SORENESS.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: REDNESS, SWELLING AREA ABOUT SIZE 2"X4", ITCHING, FEVER. ON 4/25/14 LARGER RED AREA WITH SORENESS UNDER ARM ALSO. HARD AND HOT TO TOUCH. CONTINUED SORENESS.
Age: 2.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Joint swelling, Local swelling, Neck pain, Pyrexia, Streptococcus test negative
Clinical narrative: Patient complained of "neck hurts". Neck swelling, jaw and cheek swelling. Low grade fevers ranging between 99.4-99.9 degrees F.
Age: 2.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Swelling face
Clinical narrative: Patient complained of "neck hurts". Neck swelling, jaw and cheek swelling. Low grade fevers ranging between 99.4-99.9 degrees F.
Age: 2.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Swelling
Clinical narrative: Patient complained of "neck hurts". Neck swelling, jaw and cheek swelling. Low grade fevers ranging between 99.4-99.9 degrees F.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Vaccination complication
Clinical narrative: She reported a 6 inch red, itchy streak down her injection arm. She was going to the ER to have it examined. At the ER, it was determined that she had a reaction to a component of the vaccine and received a prescription for cephelaxin.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Injection site pain, Local swelling, Muscular weakness, Paraesthesia
Clinical narrative: Patient developed persistent pain in left upper extremity in the upper arm, and has had persistent pain there with some initial numbness/tingling in that arm that resolved, but pain persists and also a complaint of weakness in that arm.  She complains of mild area of swelling, but not at site of injection, a few inches below.
Age: 55.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Fatigue, Local swelling, Muscular weakness, Pain in extremity
Clinical narrative: Patient developed persistent pain in left upper extremity in the upper arm, and has had persistent pain there with some initial numbness/tingling in that arm that resolved, but pain persists and also a complaint of weakness in that arm.  She complains of mild area of swelling, but not at site of injection, a few inches below.
Age: 49.0
Sex: F
Vaccine: IPV
Symptoms: Gait disturbance, Headache, Muscular weakness, Myalgia
Clinical narrative: Awoke on the following morning with bad headache and generalized muscle pain and weakness, difficulty lifting feet, walking in a shuffle, stairs difficult.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: Seizures.
Age: 21.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Local swelling, Pain, Pyrexia, Skin warm, Vomiting
Clinical narrative: Pain with movement of right arm, area hot, swollen, ran fever of 101.2, vomiting--no treatment--symptoms subsided by next morning.
Age: 5.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Erythema, Local reaction, Local swelling
Clinical narrative: Large local reaction; red swollen to elbow - seen in office, recommended Motrin/Benadryl/ice.
Age: 32.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: Pt reported back to our clinic at 10:30AM on 04/25/2014 complaining of pain in the back of his head, fevers, chills, and local pain at the site. Pt had a 101.9 temp upon arrival.
Age: 8.0
Sex: F
Vaccine: RAB
Symptoms: Gastric disorder, Learning disability, Ovarian cyst, Renal disorder
Clinical narrative: General health issues thruout life, stomach, left ovary cysts, learning disabilities, kidney.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: Fainted. Sudden drop of blood pressure. Was given juice and monitored until blood pressure was stable again.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Approximately 7-10 minutes after administration, MA notified this RN that pt was pale, diaphoretic, and felt faint. Upon entering exam room, pt was sitting in the procedure chair at a 45 degree angle. Her lips were pale, she was slightly diaphoretic, alert and oriented x 3. This RN placed pt in Trendelenburg position. After 2-3 minutes pt's lips gained faint pinkness, she stated she was starting to feel a little bit better. MA obtained pt vital signs and remained in room with patient. Blood pressure 98/82 with 98F tympanic. This RN re-checked pt after 5 minutes in Trendelenburg position. Pt has regained full color in her face and lips. She is no longer diaphoretic. She states she feels 90% improved and feels she can leave comfortably. MA rechecked blood pressure, now up to 118/60. Pt slowly stood up from the procedure chair with this RN and MA by her side. MA walked with patient to the parking lot. Pt left clinic in stable condition with no concerns.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Extreme swelling and redness at injection site about softball sized area, sore throat, chills, nausea, achiness, flu-like symptoms, sore shoulder joint, hard to move shoulder (left).
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Oropharyngeal pain, Pain
Clinical narrative: Extreme swelling and redness at injection site about softball sized area, sore throat, chills, nausea, achiness, flu-like symptoms, sore shoulder joint, hard to move shoulder (left).
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Restless legs syndrome
Clinical narrative: Appoximate date.  Developed restless leg syndrome after receiving Gardasil.  Was given medications for Parkinson's. Was dizzy immediately after vaccine.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Polymerase chain reaction, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Pt. developed varicella zoster after immunization. Adm IV acyclovir and isolation.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Atypical pneumonia, Bacterial test negative
Clinical narrative: This spontaneous report as received from a physician, as part of a marketing research program, refers to a 72 year old male. The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, in 2006, the patient received a dose of PNEUMOVAX23, 0.5 ml, (Lot #, expiry date, and route were not provided). Co-suspect therapy and concomitant medication were not provided. In autumn of 2010, approximately in September 2010, the patient experienced pneumonia (atypical bacteria) and was hospitalized (hospitalization dates were not provided). On an unspecified date, in February 2011, the patient recovered from the event. The reporter considered pneumonia (atypical bacteria) to be not related to PNEUMOVAX23. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse, concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 07-APR-2014, the patient was vaccinated with GARDASIL (strength, lot number and expiration date were not reported), 0.5 ml, intramuscular. Co-suspect and concomitant therapies were not reported. The nurse reported that the patient received improperly stored GARDASIL, exposed to 35 to 43 hours and no adverse event was reported. Additional information has been requested.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient (gender unknown). Medical history and concurrent conditions were not reported. On 13-JAN-2014, ROTATEQ was stored outside the recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside the recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 24-JAN-2014, the patient was vaccinated with dose 3 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014. Concomitant therapy was not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. 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 registered nurse refers to a patient of unknown age and gender. On 11-JAN-2013 the patient was vaccinated with GARDASIL dose 1 (dose and route were not reported). On 17-JAN-2014, the patient was vaccinated with GARDASIL dose 2 (dose and route were not reported) and on 22-APR-2014 the patient was vaccinated with GARDASIL dose 3 (dose and route were not reported). The patient experienced inappropriate administration schedule and no adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX via an unknown route of administration. Past medical history and concomitant medications were not reported. The pharmacist stated that ZOSTAVAX was accidentally stored in the refrigerator at 42F for 24 hours on an unspecified date. Six doses of the improperly stored ZOSTAVAX were administered to unspecified patients on unspecified dates. At the time of this report, no adverse effects were reported. The outcome of six doses of the improperly stored ZOSTAVAX were administered to unspecified patients is unknown. Additional information is not expected.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 year old patient. On an unknown date the patient was vaccinated with VAQTA. Past medical history and concomitant medications were not reported. On an unknown date the patient was inadvertently administered a pediatric dose of VAQTA for their second shot in the series. At the time of this report, no adverse effects were reported. The outcome of inadvertently administered a pediatric dose of VAQTA for their second shot in the series is unknown. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site induration, Injection site reaction, Injection site swelling, Skin tightness
Clinical narrative: (+) (R) deltoid tight, swollen and slightly hardened.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Chills, Pain, Presyncope
Clinical narrative: Presyncopal episode in office. After arriving home had temp of 102 degrees, chills, aches.
Age: 32.0
Sex: F
Vaccine: PPV, TYP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: Swelling and redness of arm from deltoid to just above wrist.
Age: 0.54
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Rash, Swelling face, Urticaria
Clinical narrative: Had vaccines 4/23. On 4/25 developed hives, facial swelling at 1300 given BENADRYL by EMS. Seen by Dr in clinic at 1430 - had hives on face; no swelling; lacy rash lower abdomen.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient called today to report swelling, redress and warmth at site of PNEUMOVAX, accompanied with a low grade fever. She took ibuprofen and then BENADRYL on recommendation. The patient after a few hours of initial phone call, reported that the reaction has not gotten worse and will continue to take BENADRYL until can speak to doctor.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain, Swelling
Clinical narrative: Patient received ZOSTAVAX SQ injection on 4-22-14. Patient's arm at injection site and beyond has been painful and swollen since injection. She saw her M.D. on 4-24-14 and was given cefadroxil in case of secondary infection. Pharmacy will follow-up with patient.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Rash, Swelling
Clinical narrative: Rash, Bumps, Swelling, Fever, Itchy (Still going on, as of today 4/25/14.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Red, swollen and inflamed around injection site. Patient is going to take Benadryl and apply topically also and monitor.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site bruising, Injection site induration, Injection site pain
Clinical narrative: R upper thigh with tenderness and bruising and spherical 1 inch subcutaneous firm area, no redness or warmth superficially.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: LOCALIZED REDNESS AND ITCHING AT INJECTION SITE LEFT ARM.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Injection site anaesthesia, Injection site joint movement impairment
Clinical narrative: Arm is numb between the top of left shoulder and left elbow. It is so numb I have difficulty pulling my pants up on the left side. I can not shrug my left shoulder with left elbow bent.
Age: 1.6
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Rash, Urticaria
Clinical narrative: Hives/rash on the stomach, back, legs, arms, neck, face.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a male patient (reported as pharmacist's father) of unknown age with none drug reactions and allergies. In approximately 2013 (reported as about a year ago) the patient was vaccinated subcutaneously with shot of ZOSTAVAX, vial (lot# and expiration date not provided) (dose not reported). In approximately 2013 (reported as happened instantaneously) the patient experienced an injection site rash. The reporter stated that the rash disappeared shortly after it appeared. No diagnostic tests were reported. The patient did not seek medical attention. The outcome of injection site rash was reported as recovered/resolved (date unspecified). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's pertinent medical history was not provided. On 17-APR-2014 the patient was vaccinated with ZOSTAVAX. Approximately in April 2014 (reported as few days after) the patient developed shingles. The pharmacist reports that the patient went to the emergency room (date of visit to the emergency room and name of emergency room was unspecified) and was diagnosed with shingles. Shingles were treated with antiviral Valacyclovir (manufacturer unknown). The outcome of shingles was unknown. The causality was not reported. The patient sought medical attention. Additional information has been requested.
Age: 0.16
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age. On an unknown date, the patient was vaccinated with temperature recursion experienced PEDVAXHIB lot # J009714. The outcome of the event was not reported. On 22-APR-2014, a phone call was placed to healthcare worker. The phone call went directly to voicemail. A voicemail message was left requesting that the healthcare worker return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. On 22-APR-2014, a phone call was received from healthcare worker. The healthcare worker was able to list the vaccines that experienced a temperature excursion. The healthcare worker stated she would do further research and attempt to fax over the list of patients who received the vaccines that had experienced a temperature excursion, by Lot number and also include the date of vaccination. The event temperature recursion experienced vaccine was considered to be not related to PEDVAXHIB. This case is linked to the case # 1404USA010658, # 1404USA010659, # 1404USA012082, # 1404USA012083, # 1404USA012084, # 1404USA012085, # 1404USA012086, # 1404USA012087, # 1404USA012088 and # 1404USA012089 (same reporter link). Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unknown number of patients with unknown demography. On an unknown date, the unknown number of patients was vaccinated with improperly stored M-M-R II (dose, route and frequency were not reported) lot # J003790. No adverse effect reported. On 22-APR-2014, a phone call was placed to healthcare worker. The phone call went directly to voicemail. A voicemail message was left requesting that the healthcare worker return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. On 22-APR-2014, a phone call was received from healthcare worker. The healthcare worker was able to list the vaccines that experienced a temperature excursion. The healthcare worker stated she would do further research and attempt to fax over the list of patients who received the vaccines that had experienced a temperature excursion, by Lot number and also include the date of vaccination. The event temperature recursion experienced vaccine was considered to be not related to PEDVAXHIB. This case is linked to the case # 1404USA010658, # WAES1404USA010659, # WAES1404USA012083, # WAES1404USA012084, # WAES1404USA012085, # WAES1404USA012086, WAES1404USA012087, #1404USA012088, # 1404USA012089 and #1404USA012090 (same reporter link). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Pain, Pyrexia
Clinical narrative: Urticaria at injection site. Upper (R) arm reddened and swollen. Fever 101. Warm compresses, MOTRIN for pain, ZYRTEC 10mg 1 daily PRN Prednisone 20mg - 2 tabs daily x 3days. Placed on allergy list.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: Mark at injection site appeared, tender in that area, mark had almost gone down to elbow.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site pain
Clinical narrative: Mark at injection site appeared, tender in that area, mark had almost gone down to elbow.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Pain
Clinical narrative: Pain at injection site worsening over time and involving the right shoulder.  Patient without redness or swelling. Physical exam c/w pain with active and passive ROM and +impingment testing.  Pain over subacromial bursa. No swelling warmth redness. Pain at site of injection.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Muscular weakness, Nausea, Paraesthesia, Throat tightness
Clinical narrative: Tingling and weakness in extremities, airway tightening, nausea, extreme fatigue. Symptoms came in waves approximately 5 minutes apart. Administration of Zofran, Prednisone and Benadryl.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Area around injection site developed a swollen and painful, red rash that was warm to the touch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Laboratory test, Pain in extremity, Skin warm, Swelling
Clinical narrative: Right arm redness, heat and swelling that encompassed entire upper arm. Arm was painful to touch and to move. Visited Emergency Room, where labs and IV fluids were administered as well as IV Ceftriaxone and prescriptions for Septra and Keflex. Patient received 3 vaccinations that day, 2 in his right arm and 1 in his left. He received MMR, IPV and DTAP but it was not documented which vaccine he received in which arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: X-ray limb
Clinical narrative: Right arm redness, heat and swelling that encompassed entire upper arm. Arm was painful to touch and to move. Visited Emergency Room, where labs and IV fluids were administered as well as IV Ceftriaxone and prescriptions for Septra and Keflex. Patient received 3 vaccinations that day, 2 in his right arm and 1 in his left. He received MMR, IPV and DTAP but it was not documented which vaccine he received in which arm.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling hot, Nausea
Clinical narrative: This spontaneous report was received from a male patient of unknown age regarding himself. The patient's medical history was not reported. In 2010 (Reported as about 10 years ago) the patient was vaccinated with first dose of ZOSTAVAX. No adverse reactions were reported after the first shot of ZOSTAVAX. On an unknown date the patient was vaccine with second shot of ZOSTAVAX as a booster. On an unknown date patient experienced his body as hot, sick to stomach and felt awful. The patient stated that he felt like it was going to kill him. The outcome of the events was unknown. The causality was not reported. 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 unknown number of patients of unknown age and gender whom in January 2014 were vaccinated with GARDASIL (dose, route and lot # not reported) that had been improperly stored. No adverse effects reported. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients. The patients received doses of ROTATEQ and GARDASIL on unspecified dates that were improperly stored since an unspecified date in April 2012 until an unspecified date in April 2014. No adverse effects were 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 medical assistant refers to an unspecified number of patients. The patients received doses of Oral ROTATEQ on unspecified dates that were improperly stored since an unspecified date in April 2012 until an unspecified date in April 2014. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Two days after ZOSTAVAX subq injection, patient has a slightly red 2" circle around site 2" above elbow - slightly warm to touch.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, raised area shaped circle, approximately 2-5 inches, warm at injection site. MD was contacted both MD and RPh stated take antiinflammatory, antihistamine and ice pack.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site rash, Injection site pruritus
Clinical narrative: Approximately 48 hours after administration patient reported localized itchy rash at administration site.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Herpes zoster, Paralysis
Clinical narrative: This spontaneous report was received from a 73-year-old male physician (also a patient). The patient's pertinent medical history includes elevated cholesterol. There were no drug reactions or allergies reported. On an unknown date in 2013 (reported as about one year ago) the patient was vaccinated with, a dose of ZOSTAVAX [Lot # unspecified] Vial, subcutaneous injection (dose and frequency unspecified). Concomitant therapies included LIPITOR, aspirin and lisinopril. On an unknown date in 2013 (reported as within 10 days of receiving ZOSTAVAX) the patient developed shingles on his right side and few days after that second outbreak occurred in an area below the first area. On an unknown date in 2013, the patient also experienced muscular paralysis in the area of his abdomen (medically significant) and stated that there was a bulge in his abdomen. The patient received the treatment for the events with codeine. There were no lab diagnostic tests performed. The patient sought medical attention by making a phone call to another physician (his colleague). There was no intervention to prevent the serious criteria. The event was not life-threatening. There was no significant disability and no hospitalization. It was reported that VZV packet was faxed. There was no PQC involved. The physician reported that he completely recovered within 2 weeks from the start of developing shingles. The outcome of the events was reported as recovered. The causality of the events was unspecified. Upon internal review the event of muscular paralysis was considered as medically significant. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Blood culture negative, Computerised tomogram head normal, Full blood count normal, Gaze palsy, Metabolic function test normal
Clinical narrative: The purpose of this analysis was to describe cranial nerve palsies, other than VII, that have been reported to the Vaccine Adverse Event Reporting System (VAERS) after routine vaccination. Because motor deficits may be more concerning to patients and clinicians than purely sensory neuropathies, and because sensory changes were highly subjective and difficult to document, this analysis focuses on palsies. Therefore disturbances of cranial nerve VIII and the sensory branches of V are not included. The reporter identified 108 reports of possible cranial nerve palsies. Upon manual review, 37 reports were found to contain no symptoms of cranial nerve paresis or paralysis; often these reports described sensory disturbances of cranial nerves (e.g., trigeminal neuralgia or hypoacusis) with no motor deficit, one report was determined to be a duplicate of an earlier report, and two reports were excluded because they concerned cranial nerve palsies that began before vaccination. Thus, 68 reports remained in the analysis, with 43 listing a single vaccine and 25 listing multiple concomitantly administered vaccines. In 48 cases (71%), the cranial nerve palsy was the primary adverse event reported to VAERS. This literature marketed report as received from a physician refers to a 1 year old female patient. On an unknown date the patient was vaccinated with MMR, dose frequency unspecified. Concomitant therapy was unspecified. On an unknown date, girl developed disconjugate gaze (hospitalization) six days after routine immunization with MMR (manufacturer unknown). There was no documentation of an alternative explanation, such as a head injury or recent illness. The patient was admitted to the hospital for a diagnostic work-up of new-onset left cranial nerve VI palsy. Investigations included magnetic resonance imaging (MRI) and CT of the brain, complete blood count, comprehensive metabolic profile, and blood cultures. All tests were within normal limits, and Guillain-Barre Syndrome was ruled out. The discharge diagnoses included idiopathic abducens nerve palsy on the left (hospitalization) and disconjugate gaze. The outcome of idiopathic abducens nerve palsy and disconjugate gaze was unknown. The reporters causality assessment for the event idiopathic abducens nerve palsy and disconjugate gaze with the therapy of MMR (manufacturer unknown) was reported to be related. Upon internal review, the event of idiopathic abducens nerve palsy on the left was considered as medically significant. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Nuclear magnetic resonance imaging brain normal, VIth nerve paralysis
Clinical narrative: The purpose of this analysis was to describe cranial nerve palsies, other than VII, that have been reported to the Vaccine Adverse Event Reporting System (VAERS) after routine vaccination. Because motor deficits may be more concerning to patients and clinicians than purely sensory neuropathies, and because sensory changes were highly subjective and difficult to document, this analysis focuses on palsies. Therefore disturbances of cranial nerve VIII and the sensory branches of V are not included. The reporter identified 108 reports of possible cranial nerve palsies. Upon manual review, 37 reports were found to contain no symptoms of cranial nerve paresis or paralysis; often these reports described sensory disturbances of cranial nerves (e.g., trigeminal neuralgia or hypoacusis) with no motor deficit, one report was determined to be a duplicate of an earlier report, and two reports were excluded because they concerned cranial nerve palsies that began before vaccination. Thus, 68 reports remained in the analysis, with 43 listing a single vaccine and 25 listing multiple concomitantly administered vaccines. In 48 cases (71%), the cranial nerve palsy was the primary adverse event reported to VAERS. This literature marketed report as received from a physician refers to a 1 year old female patient. On an unknown date the patient was vaccinated with MMR, dose frequency unspecified. Concomitant therapy was unspecified. On an unknown date, girl developed disconjugate gaze (hospitalization) six days after routine immunization with MMR (manufacturer unknown). There was no documentation of an alternative explanation, such as a head injury or recent illness. The patient was admitted to the hospital for a diagnostic work-up of new-onset left cranial nerve VI palsy. Investigations included magnetic resonance imaging (MRI) and CT of the brain, complete blood count, comprehensive metabolic profile, and blood cultures. All tests were within normal limits, and Guillain-Barre Syndrome was ruled out. The discharge diagnoses included idiopathic abducens nerve palsy on the left (hospitalization) and disconjugate gaze. The outcome of idiopathic abducens nerve palsy and disconjugate gaze was unknown. The reporters causality assessment for the event idiopathic abducens nerve palsy and disconjugate gaze with the therapy of MMR (manufacturer unknown) was reported to be related. Upon internal review, the event of idiopathic abducens nerve palsy on the left was considered as medically significant. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Inflammation, Tendon pain, Tendon rupture
Clinical narrative: Case number PHHY2014US046040 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 520224) website on 14 Apr 2014 with a follow up report was received from the Quality Assurance department on 24 Apr 2014. This report refers to a 36-year-old female patient. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 19 Dec 2013. Post vaccination, she immediately experienced tendon soreness / inflammation / rupture. The doctor felt that it was administered too high on the deltoid. She had a visit to emergency room due to these events. These events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Outcome of the events was unknown. Causality of the events was not reported. Upon follow up the quality assurance department confirmed that the reported batch number of FLUVIRIN (1346) was an invalid batch number. Follow up report received from the Quality Assurance department on 24 Apr 2014: The reported batch number of FLUVIRIN (1346) was confirmed not be a valid batch number of FLUVIRIN by the quality assurance department.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Tendon pain, Tendon rupture, Tendonitis
Clinical narrative: Case number PHHY2014US046040 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 520224) website on 14 Apr 2014 with a follow up report was received from the Quality Assurance department on 24 Apr 2014. This report refers to a 36-year-old female patient. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 19 Dec 2013. Post vaccination, she immediately experienced tendon soreness / inflammation / rupture. The doctor felt that it was administered too high on the deltoid. She had a visit to emergency room due to these events. These events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Outcome of the events was unknown. Causality of the events was not reported. Upon follow up the quality assurance department confirmed that the reported batch number of FLUVIRIN (1346) was an invalid batch number. Follow up report received from the Quality Assurance department on 24 Apr 2014: The reported batch number of FLUVIRIN (1346) was confirmed not be a valid batch number of FLUVIRIN by the quality assurance department.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Nervousness, Pallor, Syncope
Clinical narrative: Case number PHHY2014US047295, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521817) website on 14 Apr 2014 and a follow up report from the QA department received on 23 Apr 2014. This report refers to a 33 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into her left arm on 04 Feb 2014. She was pale, anxious and nervous. On the same day, five minutes after the vaccination, she fainted, regained consciousness within 5-10 minutes and was fully aware of her surroundings. She was not injured and she stated that she tends to faint when she is nervous. She stayed in a resting position for approximately 20-25 minutes before leaving on her own power. She completely recovered from the events on an unspecified date. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the events was not reported. QA department stated that the batch number (1339) was not the correct batch number of FLUVIRIN and hence no QA investigation would be initiated. Follow up report from the QA department received on 23 Apr 2014: No QA investigation would be initiated as the batch number (1339) was not the correct batch number of FLUVIRIN.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Loss of consciousness, Nervousness, Pallor, Syncope
Clinical narrative: Case number PHHY2014US047295, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 521817) website on 14 Apr 2014 and a follow up report from the QA department received on 23 Apr 2014. This report refers to a 33 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into her left arm on 04 Feb 2014. She was pale, anxious and nervous. On the same day, five minutes after the vaccination, she fainted, regained consciousness within 5-10 minutes and was fully aware of her surroundings. She was not injured and she stated that she tends to faint when she is nervous. She stayed in a resting position for approximately 20-25 minutes before leaving on her own power. She completely recovered from the events on an unspecified date. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the events was not reported. QA department stated that the batch number (1339) was not the correct batch number of FLUVIRIN and hence no QA investigation would be initiated. Follow up report from the QA department received on 23 Apr 2014: No QA investigation would be initiated as the batch number (1339) was not the correct batch number of FLUVIRIN.
Age: 51.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Guillain-Barre syndrome, Muscular weakness, Pneumonia, Rhabdomyolysis
Clinical narrative: Case number PHHY2014US046073 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521940) web site on 14 Apr 2014 with a follow up information received from the quality assurance department on 23 Apr 2014. This report refers to a 51 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly on 11 Sep 2013. On 04 Jan 2014, she experienced weakness of lower extremities. She was seen in emergency room and was hospitalized. She was diagnosed with Guillain Barre syndrome and was treated. She was still recuperating after discharge from Guillain Barre and went on to develop bilateral pneumonia with rhabdomyolysis. The event led to prolonged hospitalization of 15 days. The event outcome was unknown. The causality was not reported. Upon follow up receipt from quality assurance department on 23 Apr 2014, it was reported that the initially reported batch number 1307601 was not a valid FLUCELVAX batch number and hence a QA investigation would not be performed. Follow up information received from the quality assurance department on 23 Apr 2014: QA investigation would not be performed as the reported FLUCELVAX batch number was invalid.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, MNQ, TDAP, ADEN_4_7, FLU3, IPV, MNQ, TDAP
Symptoms: Arthralgia, C-reactive protein increased, Erythema, Swelling
Clinical narrative: Case number PHHY2014US046586 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521941) web site on 14 Apr 2014, with a follow up report received from the Quality Assurance department on 23 Apr 2014. This report refers to an 18 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with AGRIFLU (batch number: unknown) intramuscularly on 31 Jan 2013. He also received Adenovirus type 4 and 7 live oral vaccine (other manufacturer, batch number: 34600150), MENACTRA (other manufacturer, batch number: U4597AB) intramuscularly, BOOSTRIX (other manufacturer, batch number: TA3ZZ) intramuscularly and POLIOVAX (other manufacturer, batch number: J1561) intramuscularly on the same day. On 01 Feb 2014, his C-reactive protein (CRP) was 8.6 (units and normal values were not reported). He also experienced bilateral ankle pain, redness and swelling. He was hospitalized for 5 days. His C-reactive protein improved to 2.3 following treatment with steroids and antihistamines. The events were reported as complete recovery. The event was reported as serious due to hospitalization. The causality of the events was not reported. Upon follow up from the quality assurance department confirmed that, the reported batch number for AGRIFLU (1341P) was not a valid batch number for AGRIFLU. Follow up report received from the Quality Assurance Department on 23 Apr 2014: The reported batch number of AGRIFLU (1341P) was confirmed not to be a valid batch number for AGRIFLU by the quality assurance department. Hence no batch review will be performed.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, MNQ, TDAP, ADEN_4_7, FLU3, IPV, MNQ, TDAP
Symptoms: Arthralgia, C-reactive protein increased, Erythema, Joint swelling
Clinical narrative: Case number PHHY2014US046586 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521941) web site on 14 Apr 2014, with a follow up report received from the Quality Assurance department on 23 Apr 2014. This report refers to an 18 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with AGRIFLU (batch number: unknown) intramuscularly on 31 Jan 2013. He also received Adenovirus type 4 and 7 live oral vaccine (other manufacturer, batch number: 34600150), MENACTRA (other manufacturer, batch number: U4597AB) intramuscularly, BOOSTRIX (other manufacturer, batch number: TA3ZZ) intramuscularly and POLIOVAX (other manufacturer, batch number: J1561) intramuscularly on the same day. On 01 Feb 2014, his C-reactive protein (CRP) was 8.6 (units and normal values were not reported). He also experienced bilateral ankle pain, redness and swelling. He was hospitalized for 5 days. His C-reactive protein improved to 2.3 following treatment with steroids and antihistamines. The events were reported as complete recovery. The event was reported as serious due to hospitalization. The causality of the events was not reported. Upon follow up from the quality assurance department confirmed that, the reported batch number for AGRIFLU (1341P) was not a valid batch number for AGRIFLU. Follow up report received from the Quality Assurance Department on 23 Apr 2014: The reported batch number of AGRIFLU (1341P) was confirmed not to be a valid batch number for AGRIFLU by the quality assurance department. Hence no batch review will be performed.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Antinuclear antibody positive, Atelectasis, Blood chromogranin A, Complement factor increased, Condition aggravated
Clinical narrative: Case number PHHY2014US046120, is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 522196) website on 14 Apr 2014 with a follow up report received from the Quality Assurance department on 24 Apr 2014. This report refers to a 64-year-old female patient. Her medical history included atelectasis, diabetes, asthma, hypoparathyroidism, GERD (gastrooesophageal reflux disease) and small airways disease. Concomitant drugs included metformin, losartan, prednisone, glyburide and hydrochlorothiazide. She was vaccinated with AGRIFLU (batch number: unknown) along with PNEUMOVAX (batch number: H020684) intramuscularly in the left arm on 07 Mar 2013. On 08 Mar 2013, within 12 hours after vaccinations she had flu like symptoms and wheezing with breathing difficulties. She returned to the doctor on 11 Mar 2013, 14 Mar 2013, 03 Apr 2013 and was finally hospitalized on 07 Apr 2013. The lab data showed atelectasis, complement total 193, neutrophil 8.85, chromogranin 900 and ANA (anti-nuclear antibody pattern) positive. The patient was hospitalized for 4 days (reported as prolonged hospitalization). The final outcome of the events reported as not recovered. The causality of the events was not reported. Upon follow up the quality assurance department confirmed that the reported batch number of AGRIFLU (1206401) was a valid batch number for AGRIFLU. Follow up report received from the quality assurance department on 24 Apr 2014: The reported batch number of AGRIFLU (1206401) was confirmed not to be a valid batch number for AGRIFLU by the quality assurance department.