chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Nausea, Walking aid user
Clinical narrative: Information has been received from a patient's mother via an online article regarding her 17 year old daughter. There was no relevant medical history or drug reactions/allergies reported. The article stated that "two years ago" the patient's pediatrician recommended the patient to get GARDASIL, which was given in 3 doses. On unknown dates the patient was vaccinated with the first and second doses of GARDASIL (dose, frequency, route, lot# and expiration dates unspecified). After the first dose, the reporter said the patient was fine but after the second dose the patient was sick within a week at the doctors with nausea which had not left her to this day. The patient said "I have nausea 24/7, dizziness, 24/7 muscle pain, weakness in my legs, back pain, joint pain. Some days I have to walk with a cane". "The events had been going on for the past two years". The reporter said "it was devastating for her, because she can't have a normal life". The patient's health got so bad after getting GARDASIL. At the time of reporting, the patient was undergoing IV treatments once per week. Outcome of the events and causality were not provided. This is one of several reports from the same reporter. Upon internal review, the events of muscle pain, weakness in my legs, back pain, joint pain were considered as disable due to some days the patient had to walk with a cane. Additional information is not expected as no follow up available.
Age: 1.29
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Urticaria over all body.  Was given Benadryl at home.  Was seen 9/15/15 and given DepoMedrol and instructed to continue Benadryl as needed.  Rash was beginning to fade according to mother when child was seen on 9/15/15.
Age: 0.25
Sex: M
Vaccine: PNC13
Symptoms: Apparent life threatening event, Cough, Dyspnoea, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Approximately 8 hours after vaccine administration baby developed dumplings, coughing and difficulty breathing. Was taken to hospital by ambulance and admitted for 24 hours for observation. Discharged home with diagnosis ALTE.
Age: 65.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site reaction - redness and warmth of the injection site.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Injection site red and swollen painful to the touch. No pain on movement of arm. Patient instructions 1) rest arm 2)  apply ice 20 minutes at a time every 2 hrs when possible 3)  observe for increased redness, increased swelling, pain, red streak to axilla of fever. Follow up with PCP if any of these signs develop.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Flushing, Headache, Nausea
Clinical narrative: Nausea, dizziness, headache and flushing of face an hour after injection.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Abasia, Asthenia, Dizziness
Clinical narrative: Weakness -dizziness. Couldn't walk-hospitalized.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Oedema peripheral, Pain, Pruritus, Rash erythematous
Clinical narrative: Large amount of edema in arm, red-raised rash, itching, very painful.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Pt states that day after vaccine starting having pain, swelling and redness at injection site, a week after pt started having itching and continued swelling.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: Plunger on vaccine did not depress when attempted to administer.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Prevnar 13 administered around 9:00 AM, at 7:00 PM Resident's L deltoid - red, raised, firm, circular, warm, itches, 3.25 inches diameter area, no pain, full range of motion to L arm, no treatment, just monitoring.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Muscular weakness, Musculoskeletal chest pain
Clinical narrative: 30 minutes after receiving the vaccine he developed musculoskeletal chest pain, 2 hours later weakness in the left arm (opposite arm of immunization).  Arm weakness has resolved.  Musculoskeletal chest pain continues as of today 9/16/15.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Asthenia, Headache, Nausea, Paraesthesia, Tremor
Clinical narrative: Pt c/o of vertigo, weakness, nausea, Bp 108/60; P88.  Placed in supine position with BLE elevated.  Fine generalized tremors.  Vertigo worsened; c/o of headache and generalized tingling of body.  Skin remained warm, dry and color good.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Vertigo
Clinical narrative: Pt c/o of vertigo, weakness, nausea, Bp 108/60; P88.  Placed in supine position with BLE elevated.  Fine generalized tremors.  Vertigo worsened; c/o of headache and generalized tingling of body.  Skin remained warm, dry and color good.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Breast cancer female, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient's pertinent medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with M-M-R II (strength, dose and route of administration not reported). The nurse stated that the patient may had also received VARIVAX (Merck) previously as well but she was unsure. Concomitant medications were not reported. On an unknown date, the patient was diagnosed with breast cancer. The patient currently takes tamoxifen for Breast Cancer (also reported as for a previous history of breast cancer). On an unknown date, the patient had MMR titers drawn after receiving the M-M-R II and the result of the titers for MMR were negative (antibody test negative). The outcome of breast cancer and antibody test negative was unknown. The relatedness of the events, breast cancer and antibody test negative to M-M-R II and VARIVAX (Merck) was not provided. Upon internal review, Breast cancer was determined to be medically significant. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, PPV
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Dizziness, weakness, fatigue, would feel better for a few hours, then stayed in bed the entire next day, still on and off and it is 9-16-15.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Diffuse pain and rash 09/12/2015 to 09/14/2015.  Pain resolved and itching began 09/14/2015 PM.  Itching severity gradually worsened. Hydroxyzine po administered by wife 09/14/2015 and 09/15/2015 at bedtime improved itching.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain, Alanine aminotransferase increased, Arthritis, Aspartate aminotransferase increased, C-reactive protein increased
Clinical narrative: REACTIVATION OF ARTHRITIS WITH FOOT PAIN KNEE EFFUSION, CHILLS FEVER, MYALGIAS, ABDOMINAL PAIN, WEIGHT LOSS.  HOSPITALIZED 9/1/15 WITH ABDOMINAL PAIN OVERNIGHT.  SEEING RHEUMATOLOGY AND KNEE EFFFUSION DRAINED.  HAD INITIAL JOINT PROBLEMS WITH SIMILAR SYMPTOMS WHEN 4 YEARS OLD STARTING ABOUT 10 DAYS AFTER DTAP GIVEN 7/22/08.  RESOLVED AFTER ABOUT 4-6 MONTHS AND NO PROBLEMS IN BETWEEN.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chills, Condition aggravated, Joint effusion, Joint fluid drainage, Myalgia
Clinical narrative: REACTIVATION OF ARTHRITIS WITH FOOT PAIN KNEE EFFUSION, CHILLS FEVER, MYALGIAS, ABDOMINAL PAIN, WEIGHT LOSS.  HOSPITALIZED 9/1/15 WITH ABDOMINAL PAIN OVERNIGHT.  SEEING RHEUMATOLOGY AND KNEE EFFFUSION DRAINED.  HAD INITIAL JOINT PROBLEMS WITH SIMILAR SYMPTOMS WHEN 4 YEARS OLD STARTING ABOUT 10 DAYS AFTER DTAP GIVEN 7/22/08.  RESOLVED AFTER ABOUT 4-6 MONTHS AND NO PROBLEMS IN BETWEEN.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pain in extremity, Prothrombin time prolonged, Pyrexia, Red blood cell sedimentation rate increased, Serum ferritin increased
Clinical narrative: REACTIVATION OF ARTHRITIS WITH FOOT PAIN KNEE EFFUSION, CHILLS FEVER, MYALGIAS, ABDOMINAL PAIN, WEIGHT LOSS.  HOSPITALIZED 9/1/15 WITH ABDOMINAL PAIN OVERNIGHT.  SEEING RHEUMATOLOGY AND KNEE EFFFUSION DRAINED.  HAD INITIAL JOINT PROBLEMS WITH SIMILAR SYMPTOMS WHEN 4 YEARS OLD STARTING ABOUT 10 DAYS AFTER DTAP GIVEN 7/22/08.  RESOLVED AFTER ABOUT 4-6 MONTHS AND NO PROBLEMS IN BETWEEN.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Weight decreased
Clinical narrative: REACTIVATION OF ARTHRITIS WITH FOOT PAIN KNEE EFFUSION, CHILLS FEVER, MYALGIAS, ABDOMINAL PAIN, WEIGHT LOSS.  HOSPITALIZED 9/1/15 WITH ABDOMINAL PAIN OVERNIGHT.  SEEING RHEUMATOLOGY AND KNEE EFFFUSION DRAINED.  HAD INITIAL JOINT PROBLEMS WITH SIMILAR SYMPTOMS WHEN 4 YEARS OLD STARTING ABOUT 10 DAYS AFTER DTAP GIVEN 7/22/08.  RESOLVED AFTER ABOUT 4-6 MONTHS AND NO PROBLEMS IN BETWEEN.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Drooling, Dyskinesia, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: Pt Reported feeling nauseated, wanted to vomit, loss consciousness while seated, kept safe while experiencing seizures like symptoms, jerking of body muscles, drooling, diaphoresis, paleness, no emesis. Pt recovered withing 15 minutes.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Pallor, Seizure
Clinical narrative: Pt Reported feeling nauseated, wanted to vomit, loss consciousness while seated, kept safe while experiencing seizures like symptoms, jerking of body muscles, drooling, diaphoresis, paleness, no emesis. Pt recovered withing 15 minutes.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Local pain at injection site followed by red rash limited to upper arm surrounding injection site and skin hot to touch that resolved completely in 24 hours.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Somnolence, Vomiting
Clinical narrative: Dizziness, fell asleep, vomiting and continued dizziness. This was over the course of about 10 minutes when paramedics then arrived and transported her for further evaluation.
Age: 0.31
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Sudden infant death syndrome
Clinical narrative: Sudden unexplained infant death (SUID).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist, as part of a marketing research program, referring to a more than 65 year old female patient. The patient's medical history with no current conditions, was not reported. On an unknown date, the patient was vaccinated with one dose of ZOSTAVAX subcutaneous in the arm, (dose, lot number and expiration date were not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced an injection site reaction that was encompassing the entire inner arm (from the elbow up essentially). The outcome of the injection site reaction was reported as recovered. The reporter considered the injection site reaction to be serious and related to ZOSTAVAX. No diagnostic test were performed. Additional information is not expected as the reporter did not wish additional contact and refused to provide personal details.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Erythema and itching present to left deltoid area 17cm x 20cm. Erythema and itching present to right deltoid area 10cm x 13 cm.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: Red, swollen raised area.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: The whole upper arm was red and swollen and she said it was very painful.  She considered going to the emergency room but layed down instead.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Extra dose administered, Peripheral swelling
Clinical narrative: The whole upper arm was red and swollen and she said it was very painful.  She considered going to the emergency room but layed down instead.
Age: 70.0
Sex: M
Vaccine: FLUC3
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: ITCHY LEGS, SWOLLEN FEET.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Peripheral swelling
Clinical narrative: SHE C/O ARM SWELLING.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Vertigo
Clinical narrative: Patient reported redness and swelling at injection site plus swelling of the arm.  She also experiences some vertigo for a number of days which started a couple days after receiving the vaccine.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Pain, Swelling
Clinical narrative: Swelling, severe pain. Severe shoulder pain and reduced range of motion in the arm where a shot was given can happen.
Age: 64.0
Sex: F
Vaccine: TYP
Symptoms: Induration, Injection site bruising, Pain, Tenderness
Clinical narrative: Localized tenderness with induration.  Pain when lifting arm, taking Motrin with little relief, still tender 2.5 weeks after injection.  Small bruising at site.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Tenderness, itching, erythema, warm to touch at injection site.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Started breaking out behind my left knee. Still have breakout that looks like streaks across back left calf.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash - Itch - using Benadryl and hydrocortisone cream.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Mouth ulceration, Oral herpes, Pharyngeal ulceration
Clinical narrative: PATIENT SAID DEVELOPED A DOZEN ULCERS IN HER MOUTH AND THROAT. SHE WENT TO HER DENTIST WHO GAVE HER A DEXAMETHASONE MOUTHWASH THAT SHE USED FOUR TIMES DAILY. SHE ALSO DEVELOPED COLD SORES WHICH SHE USED ABREVA FOR.
Age: 12.0
Sex: M
Vaccine: FLUX, HPVX
Symptoms: Dyskinesia, Fall, Head injury, Hypophagia, Loss of consciousness
Clinical narrative: Syncope episode after receiving second scheduled dose of HPV vaccine, with resultant fall from parents lap. Pt had involuntary motions and short loss of awareness. After hitting floor s/p fall & hitting head. Monitored, EMS called, resolved prior to EMS visit. Had decreased PO intake first day per patient.
Age: 12.0
Sex: M
Vaccine: FLUX, HPVX
Symptoms: Syncope
Clinical narrative: Syncope episode after receiving second scheduled dose of HPV vaccine, with resultant fall from parents lap. Pt had involuntary motions and short loss of awareness. After hitting floor s/p fall & hitting head. Monitored, EMS called, resolved prior to EMS visit. Had decreased PO intake first day per patient.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Large bruising at injection site.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Local swelling, Pruritus
Clinical narrative: Complaints that a quarter size bump that didn't hurt but itched was on her left arm.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, tender to touch, painful, itchy at the left deltoid at subcutaneous muscle.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Condition aggravated, Injection site warmth, Migraine, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: Migrane, vomiting, warmth at injection site, muscle of shoulder and neck on side of injection site was stiff and tight, fever of 102 F. Symptoms cleared by 6:00 am on 9/16/15.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia, Vomiting
Clinical narrative: Migrane, vomiting, warmth at injection site, muscle of shoulder and neck on side of injection site was stiff and tight, fever of 102 F. Symptoms cleared by 6:00 am on 9/16/15.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Induration, Local swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Presented with pain, swelling & itching of the left proximal arm. Left arm with small area of induration (about 2mc in diameter), erythema, warmth & swelling however expands down near antecubital fossa.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pruritus, Skin warm
Clinical narrative: Presented with pain, swelling & itching of the left proximal arm. Left arm with small area of induration (about 2mc in diameter), erythema, warmth & swelling however expands down near antecubital fossa.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Blood test, Monoplegia, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Patient started w/pain in her elbow and wrist which has progressed to monoplegia on her right side.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Tenderness
Clinical narrative: Swelling and tenderness noted along left supraclavicular area.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin irritation, Skin warm
Clinical narrative: The patient reported that there was some irritation, itching, redness, and warmth that began under the injection site and spread to just under the bicep. She reported this today but she reported that it is getting better already.
Age: 70.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Abdominal pain upper, Blood glucose, Dizziness postural
Clinical narrative: Upon getting shot patient satated stomach pain and said he felt dizzy upon standing. Checked patient blood pressure and blood glucose. After a few minutes (15-20 minutes) patient left pharmacy stating he was fine soon therafter.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient reports rash on hands in creases, on legs, center of back and on waist.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Local swelling, Pain, Pruritus, Rash erythematous
Clinical narrative: Red rash, itching, swelling, and a lot of pain in the area.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Patient said that the immunizations were very painful when being injected subcutaneously and uncomfortable for many days. When in on 9/16/2015 the arm appeared normal and patint said there was no more pain.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site swelling, Malaise, Nausea
Clinical narrative: Swelling around injection site and nausea and generally not feeling well.
Age: 14.0
Sex: F
Vaccine: IPV, TDAP, VARCEL
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hive, redness and itchy.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Swelling and redness at site of injection. Soreness in arm when moving or lifting arm.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster
Clinical narrative: SHINGLES ON BACK, DISCOMFORT. WENT TO DR ON 9/15/2015 AND RECEIVED TREATMENT FOR SHINGLES.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: This currently 71 year old female patient received a pneumonia vaccine "some time in the last week" in 2015. On 16Sep2015, the patient came to pharmacy to get a flu vaccine. The arm the pneumonia vaccine was administered to was red and hot. The patient was referred to her primary care provider and did not receive the flu vaccine. As of 16Sep2015 the patient left the pharmacy for her primary care providers office and the outcome of the event is unknown.
Age: 54.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Bronchitis
Clinical narrative: Case number PHEH2015US017620 is an initial spontaneous report received from a pharmacist on 08 Sep 2015. This report refers to a 54 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 157021) intramuscularly on an unknown date. She also received ZOSTAVAX (other manufacturer, batch number: not reported) along with FLUVIRIN. On 24 Aug 2015, the patient experienced bronchitis. The events outcome was unknown. The seriousness of the events was not reported, but the event bronchitis was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness
Clinical narrative: Information has been received from an unspecified reporter via an online article, regarding a 16 year old female patient. There was no relevant medical history or drug reactions/allergies reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route, lot# and expiration date unspecified). On an unknown date the patient lost her eyesight and was taken to a hospital. Doctors at the hospital believed the vaccine might have caused her blindness. Outcome of the event was unknown. Upon internal review, the event "lost her eyesight" was considered to be medically significant. This is one of several reports from the same source. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Rash
Clinical narrative: Patient received the FLUZONE HIGH-DOSE on the left arm on 9/14/15. On 9/15/15 evening, she came to the pharmacy and reported reswollen left arm with rashes.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Malaise, Nausea
Clinical narrative: Patient felt nauseous, lips were swollen, spent the night sick in bed after the flu shot.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pain
Clinical narrative: Vomiting once, pain all over, sore muscles/joint. Chills, fatigue.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vomiting once, pain all over, sore muscles/joint. Chills, fatigue.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Contusion, Ear infection, Haematoma, Injection site pain
Clinical narrative: Pt had a solid hematoma (very bad bruise) from shoulder to elbow, bronchitis, ear infection, sinusitis, water at the bottom of her lungs, pain at injection site. Happened after shot was given, she went to the dr and was given a course of antibiotic.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Pleural effusion, Sinusitis
Clinical narrative: Pt had a solid hematoma (very bad bruise) from shoulder to elbow, bronchitis, ear infection, sinusitis, water at the bottom of her lungs, pain at injection site. Happened after shot was given, she went to the dr and was given a course of antibiotic.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt. says she had shooting pain in left arm till middle finger. Used ADVIL for relief and slowly recovering.
Age: 94.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Pt had pruritis and redness of upper right extremity. Pt also experienced itchiness in the area.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-AUG-2015, the patient was vaccinated with the improperly stored M-M-R II (lot # K024035 and expiration date 26-NOV-2016) (dose and route of administration were not reported). On the same day the patient was vaccinated with VAQTA (lot number L009445 and expiration date 01-JUN-2017) (dose and route of administration were not reported). 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.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. The patient received his first dose of GARDASIL 9 from a single-dose vial on 09-JUN-2015 and on 04-SEP-2015, the patient was vaccinated with second dose of GARDASIL 9 intramuscularly (unknown dose) from a single-dose vial. Concomitant medications were not reported. On 04-SEP-2015, the GARDASIL 9 leaked out of the plastic syringe during administration of this second dose due to a crack at the bottom of the plastic syringe. No adverse effect was reported. There was no product quality complaint involved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site inflammation, Injection site swelling, Local reaction
Clinical narrative: Local reaction - redness/swelling/inflammation on right deltoid w/ associated red swollen axillary lymphadenopathy.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Local reaction - redness/swelling/inflammation on right deltoid w/ associated red swollen axillary lymphadenopathy.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Pt was given an INFANRIX in error was to receive ADACEL.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 21-AUG-2015, the patient was vaccinated with an unknown dose of VAQTA that was improperly stored (lot # L009445, expiry date 01-JUN-2017, route was not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 19-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA (lot # L009445, exp. date: 01-JUN-2017) (strength, dose and route were not reported). There were no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report was received from a 71 year old female patient referring to herself. The patient's medical history included shingles. The patient had no concomitant medication and no drug reactions/allergies. On 16-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX single (dose, lot#, expiry date unspecified), to lessen the effects of re-occurring shingles. On 04-SEP-2015, the patient developed shingles which was just as bad as the first time she got shingles. She also reported a lack of effectiveness for the vaccine. Patient sought medical attention but not hospitalized, and was prescribed famciclovir as a treatment. No lab diagnostic studies performed. The patient was not recovered from the events at the time of this report. No product quality complaint (PQC) reported. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 19-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA (lot # L009445, exp.date: 01-JUN-2017) (strength, dose and route were not reported). There were no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No medical history,  concurrent conditions or concomitant therapies were reported. On 28-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA lot # L009445, expiration date 01-JUN-2017 (dose, route of administration and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Upper arm sore to touch for five day, 1-5. Upper arm red and warm to touch five days, 2-6. Upper arm very itchy for six days, 2-7.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Chills, Decreased appetite, Headache, Injection site pain
Clinical narrative: Joint aches in legs, sore at shot site, bad headache, chills, loss of appetite.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was told by MD to get PREVNAR 13 since she had PNEUMOVAX quite a few years ago. We ran it thru I did administer it, not understanding the flow chart that she should wait until age 65. I was not thorough in my research before giving it. No known adverse rxn.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper arm swelling, warm to touch, itching, began 9/16/15, Tx is cool compress and BENADRYL.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Electromyogram, Fatigue, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Seen in office 8/6/15 24 hour after pneumococcal 13 vaccine, pt reports having severe joint pain and fatigue. Pt noted some tingling in his hands upon awakening which was present prior to injection but worse since 7/28/15. Also when seen 8/15/15 c/o (R) arm and hand pain worse. (R) arm swelling also present.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Paraesthesia, Peripheral swelling, Ultrasound scan, X-ray
Clinical narrative: Seen in office 8/6/15 24 hour after pneumococcal 13 vaccine, pt reports having severe joint pain and fatigue. Pt noted some tingling in his hands upon awakening which was present prior to injection but worse since 7/28/15. Also when seen 8/15/15 c/o (R) arm and hand pain worse. (R) arm swelling also present.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Adverse event, Limb operation
Clinical narrative: Seen in office 8/6/15 24 hour after pneumococcal 13 vaccine, pt reports having severe joint pain and fatigue. Pt noted some tingling in his hands upon awakening which was present prior to injection but worse since 7/28/15. Also when seen 8/15/15 c/o (R) arm and hand pain worse. (R) arm swelling also present.
Age: 67.0
Sex: M
Vaccine: HEP
Symptoms: Biopsy skin, Immunology test, Pemphigus
Clinical narrative: Development of autoimmune pemphigus reaction 3-5 weeks after Hep B vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Vasculitis
Clinical narrative: Profuse rash lasting months with varied severity, including escalating to vasculitis.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure increased, Immune system disorder, Rash, Rash pruritic, Vasculitis
Clinical narrative: Profuse rash lasting months with varied severity, including escalating to vasculitis.
Age: 51.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea, Pain
Clinical narrative: Patient with swollen and redness on (R) upper arm where pneumonia vaccine was administered. Pt also c/o headache, fever, body aches, nausea and congestion. Patient seen today by clinician and prescribed KEFLEX 500 mg 4 x/day x 7 days. Patient will f/u tomorrow.
Age: 51.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Patient with swollen and redness on (R) upper arm where pneumonia vaccine was administered. Pt also c/o headache, fever, body aches, nausea and congestion. Patient seen today by clinician and prescribed KEFLEX 500 mg 4 x/day x 7 days. Patient will f/u tomorrow.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received fro a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 21-AUG-2015, the patient was vaccinated with an unknown dose of VAQTA that was improperly stored (lot # L009445, expiry date 01-JUN-2017, route was not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, Hepatitis B surface antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a licensed practical nurse (LPN) refers to a 41 year old male patient with HIV infection. No drug allergies were reported. On 01-APR-2013, the patient was vaccinated with adult dose of RECOMBIVAX HB injection of strength 10/1.0 microgram/milliliter (mcrg/ml) (lot # H018689 and expiry date: 07-NOV-2014). On 03-SEP-2013, the patient received RECOMBIVAX HB (lot #: H011741 and expiry date 01-FEB-2015). On 01-OCT-2013, the patient received RECOMBIVAX HB (lot #: 0384AE and expiry date: 02-NOV-2014). On 21-APR-2014, the patient received RECOMBIVAX HB (lot #: J006511 and expiry date: 28-JAN-2016). On 04-SEP-2015, the patient received RECOMBIVAX HB (lot number: L010595 and expiry date: 12-NOV-2016). Concomitant therapies included ATRIPLA. In November of 2013, the patient's anti-HBs were less than 3 (hepatitis b surface antibody negative). The patient did not experience any distress or any other adverse symptoms. The outcome of hepatitis b surface antibody negative, extra dose administered and inappropriate schedule of drug administration was unknown. The causality of hepatitis b surface antibody negative was unknown. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 21-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA (lot # L009445, exp. date: 01-JUN-2017) (strength, dose and route were not reported). There were no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 24-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA (lot # L009445, exp. date: 01-JUN-2017) (strength, dose and route were not reported). There were no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX injection (lot # L012477, expiry date 10-JUL-2016; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unkonwn age and gender. The patient's concurrent conditions and medical history were nnot reported. On 29-AUG-2015, the patient was vaccinated with the improperely stored VAQTA (lot number L009445 and expiration date 01-JUN-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional inofrmation has been requested.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No medical history, concurrent conditions or concomitant therapies were reported. On 28-AUG-2015, the patient was vaccinated with VAQTA lot # L009445, expiration date 01-JUN-2017 (dose, route of administration and anatomical location were not reported) and MMR II lot # K024035, expiration date 26-NOV-2016 (dose, route of administration and anatomical location were not reported), that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No medical history, concurrent conditions or concomitant therapies were reported. On 26-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA lot # L009445, expiration date 01-JUN-2017 (dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 20-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA (lot # L009445, exp.date: 01-JUN-2017) (strength, dose and route were not reported). There were no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. On unknown dates, unspecified patients were vaccinated with an improperly stored GARDASIL (dose and route of administration not reported; lot # K011562 and expiration date on 08-APR-2017). No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. On unknown dates, unspecified patients were vaccinated with an improperly stored MMR II (dose and route of administration not reported: lot # K008814 and expiration date on 19-JUN-2016). No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot# reported as L013428, expiration date 03-FEB-2017, dose and site of administration were not reported) intramuscularly. No adverse effects were reported. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Hypoaesthesia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a 56 year old male patient referring to himself. No pertinent medical conditions and drug allergies were reported. On 03-SEP-2015, the patient was vaccinated with ZOSTAVAX for prevention of shingles (strength, dose, route, lot# and expiration date unknown). There was no concomitant medication reported. On 04-SEP-2015, the patient stated that he experienced a "bee-like sting" in this thigh the day after receiving ZOSTAVAX. He then experienced tingling, numbness and aching in the same leg. The reactions subsided on an unspecified date in September 2015. But then on 06-SEP-2015 the reactions reoccurred. He also had difficulty walking. At the time of reporting, he was still experiencing the numbness and tingling. The patient did not seek medical attention and no lab diagnostics studies were performed to the patient. The outcome of the events of aching reoccurred and difficulty walking was unknown. Causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an adult patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date in August 2015 (reported as "one month ago"), the patient was vaccinated with the first dose of VAQTA, 1 ml, intramuscularly in left arm (lot # and expiration date were not provided). On 11-SEP-2015 (reported as today), the patient was vaccinated with the second dose of VAQTA, 1 ml, intramuscularly in left arm (lot # and expiration date were not provided). No adverse effects were reported at the time of the report. Additional information is not expected as there was no consent to contact physician.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via field representative referring to a 73 year old female patient. No relevant medical history or concurrent conditions were reported. In 2010 the patient was vaccinated with ZOSTAVAX (one injection/once; route, lot# and expiration date not reported). In 2012 the patient experienced her first case of shingles and recovered on an unknown date. In 2015 the patient experienced her second case of shingles and had not recovered. Causality assessment was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Eye inflammation, Optic neuritis, Visual impairment
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a male patient in his 60's. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On an unspecified date in 2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported). On an unknown date (reported as "within a few weeks of receiving ZOSTAVAX"), the patient developed an inflammation of the eye that affected his vision. The patient visited an unspecified ophthalmologist (on an unspecified date) and was diagnosed with an "inflammatory process of the optic nerve." The patient was given an unspecified antiviral medication as a treatment for the event. The outcome of the inflammatory process of the optic nerve and relatedness between the event and ZOSTAVAX were not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 20-AUG-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route unspecified). The patient's physician prescribed an unspecified steroid for an unspecified reason on an unspecified date in 2015 (adverse event and medication error). It was also reported that no adverse effect was reported. The outcome of adverse event and medication error was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. There was no medical history or concurrent condition reported. In approximately September 2013, about two years ago, the patient was vaccinated with a dose of ZOSTAVAX (dose, lot#, expired date and route were unknown). No concomitant therapy was reported. About in March 2015 (reported as "about six months ago"), the patient was diagnosed with shingles. The outcome of the event and causality were not provided. Additional information is not expected since no contact information available.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 71 year old male patient. There was no information about concurrent condition and historical medication. On 10-SEP-2015, the patient was vaccinated with PNEUMOVAX23 lot # K009105, expiration date- 21-JAN-2016, intramuscular. No concomitant medication was reported. On an unknown date in September 2015, as reported within 2-3 hours of receiving the PNEUMOVAX23 the patient experienced injection site warmth and injection site swelling about 4 inches by 4 inches. The patient cold compresses on it. No product quality complaint (PQC) was involved. No laboratory diagnostics were performed. The outcome of injection site warmth and injection site swelling was unknown. Causality between injection site warmth and injection site swelling and PNEUMOVAX23 was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding a patient of unknown age and gender. The patient's medica history or concurrent conditions were not reported. On 04-MAR-1999, the patient was vaccinated with the first dose of MMR II (0.5 ml, subcutaneous, lot number and expiration date were not provided). On 18-JUN-2003, the patient was vaccinated with the second dose of MMR II (0.5 ml, subcutaneous, lot number and expiration date were not provided). Nurse reported unspecified patient's office record did not show the initial two doses of MMR II and the patient received another two doses of MMR II. Patient received the first dose of the second series of MMR II (0.5 ml, subcutaneous, Lot # 0128AE, expiration date 10-JAN-2014) on 14-NOV-2012 and the second dose of the second series of MMR II (0.5 ml, subcutaneous, Lot # K0166153, expiration date 24-SEP-2016) on 09-SEP-2015. No adverse effects were reported. Additional information has been requested.