chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Injection site pain, Pallor
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL, in the right arm, (dose, frequency, route of administration, lot number and expiration date were not reported). At the same time, the patient was also vaccinated with Tdap, in the left arm, (dose, frequency, route of administration, lot number and expiration date were not reported). The reporting nurse stated, that post vaccinations the patient had to be propped up by his Mom. He looked pale, feeling faint but he did not fall. As reported the patient experienced severe pain in the right arm where he received GARDASIL and severe pain in the left arm where he was vaccinated with Tdap. The nurse laid the patient down for about one hour. The patient still reported pain in the arms, but no other adverse reactions aside from that. No interventions were reported by the nurse. The reporting nurse, stated that the patient had finally got up and had walked out of the office with his parents and siblings. She also stated that she noticed that the ethnic group, as per the patient, responded that vaccinations were always paiful. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Circumstance or information capable of leading to medication error, Frustration tolerance decreased, Irritability, Medication error
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 year old female patient. The patient's relevant medical history includes sulfa allergy. The patient's concomitant medications and past drug history are unknown. On 18-APR-2015, the patient was vaccinated with ZOSTAVAX lot # K023622 dose 1, subcutaneous in the left arm. On 18-APR-2015, it appeared that the skin was not punctured and the injection solution got on the patient's jacket that was tied around her waist. The pharmacist checked the patient's arm and did not see a needle mark and there was no blood, but the patient was moving, agitated, flustered and frustrated at that time. It was unknown if the relevant lab data was done. The patient insisted that she will come back for revaccination the same day. At the time of reporting the outcome of the events was unknown. The reporter did not provide the relatedness of the events with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to mulitple unspecified patients of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. On unknown dates, multiple unspecified patients were vaccinated with ROTATEQ, lot # K005397, expiration date: 29-FEB-2016 or lot # K001198, expiration date: 25-OCT-2015, route default to oral, (dose and frequency were not reported) after it was exposed to a supported temperature excursions of 32.9F for 2 hours and 45 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. 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 registered nurse refers to multiple unspecified patients of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. On unknown dates, multiple unspecified patients were vaccinated with GARDASIL lot # H020901, expiration date: 05-JUL-2015 or lot # J012212, expiration date: 18-FEB-2016, (dose, administration route and site were not reported) after it was exposed to a supported temperature excursion of 32.9F for 2 hours and 45 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Approx 36 hrs after vaccination she developed area of redness, hot, hard to the touch and itchy at site of injection. Approx 4 inches in diameter-also 1 1/2" of black and blue-took OTC pain med and ice.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: Infant found dead at home.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Dyspnoea
Clinical narrative: Patient developed severe chills in the afternoon after getting PCV-23 he was shivering uncontrollably, his teeth were chattering, shortness of breath. Next day seen in the office, no fever, and advise to take ibuprofen.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Back pain, Fatigue, Injection site reaction, Pain
Clinical narrative: Achy body, typical site reaction, low grade fever, sore hips and back, fatigue X 3 days.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Achy body, typical site reaction, low grade fever, sore hips and back, fatigue X 3 days.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Injection site pruritus
Clinical narrative: Got my shingles shot and reaction following the shots: swelling, redness, itchiness, soreness, tingling, numbness, shot area elevated.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Got my shingles shot and reaction following the shots: swelling, redness, itchiness, soreness, tingling, numbness, shot area elevated.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling, Rash
Clinical narrative: Mother noted swelling and redness at the left arm injection site down the arm and into the forearm.  Mother also noticed rash in the underarm area which she believed to be hives.  She gave Benadryl to her daughter over the weekend. Mother contacted school nurse on 5/12/15 who contacted our clinic to make us aware of reaction.  I contacted mother at 3:20 pm on 5/12/15. Mother took her daughter into see her health care provider earlier in the day of 5/12/15.  The provider feels it is likely the swelling is a reaction to the immunization given in the arm. Mother was concerend regarding latex as daughter has a latex allergy.  I had called and given the mother latex informtation prior to immunization on 05/07/12.  She was informed the Adacel vaccine/vial nor the Menveo vaccine/vial contains latex, nor did the syringe, gloves, or bandaid used to give the Tdap and Menveo.  Tdap was given IM in the left deltoid and Menveo given Im in the right deltoid. Child has not had any airway issues, stomach issues, and is able to move arm.  Mother states arm is less red today. The child was prescribed  Tagamet and steroid cream for the rash. Mother will follow up with provider should any changes occur with her daughter's health.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abnormal behaviour, Decreased eye contact, Exaggerated startle response, Irritability
Clinical narrative: More fussy, less interactive, less eye contact, less smiling and cooing, writhing her hands, more easily startled, more stoic.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Mom states that she had varicella vaccine on 5/13. Mom states that she is having redness and swelling on arm. Redness was the size of quarter yesterday and then spread to half dollar and now is slightly bigger but not by much. Denies pain or warm to the touch. Not bothersome to patient.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Chest pain, Electrocardiogram
Clinical narrative: Chest Pain.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Flu vaccine given in left deltoid. One day later injection site and surrounding area red and swollen. Painful to touch.
Age: 51.0
Sex: F
Vaccine: HEP, HEPA, MMRV, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pro Quad given to 51 year old. Not approved for over 12 yo.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Dysstasia, Posture abnormal
Clinical narrative: Client received vaccines. Approx. 2-3 minutes later, client attempting to stand up, slouched over and slipped to floor. Client aroused few seconds later, alert but light headed.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Death, Dyspnoea
Clinical narrative: Difficulty breathing taken to hospital SAO2 level 75 put on 15 liters O2 sent home on the 01/22/2015.
Age: 1.21
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis required abx.
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain, Pain, Weight bearing difficulty
Clinical narrative: I have been experiencing severe shoulder pain and reduced range of motion in my left arm ever since I received the injection. It is a dull, aching pain that feels like a "bruise" right on my deltoid muscle at the injection site. The pain is somewhat alleviated by ibuprofen and ice, but it has persisted for several months since receiving my last flu shot. The pain is exacerbated by movements that involve lifting my arm above my head or putting weight on my deltoid/shoulder muscle (as in a push-up).
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray limb normal
Clinical narrative: I have been experiencing severe shoulder pain and reduced range of motion in my left arm ever since I received the injection. It is a dull, aching pain that feels like a "bruise" right on my deltoid muscle at the injection site. The pain is somewhat alleviated by ibuprofen and ice, but it has persisted for several months since receiving my last flu shot. The pain is exacerbated by movements that involve lifting my arm above my head or putting weight on my deltoid/shoulder muscle (as in a push-up).
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Pt passed out following 3 immunizations, hit head on counter.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Pt states that when she woke up on 5/14 that the injection site was warm, red, and raised about the size of a quarter.  Over the next 48 hours has gotten larger despite applying ice, taking Benadryl and ibuprofen.  Pt now states she feels extremely tired and muscles hurt.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Dizziness, Pain in extremity, Pyrexia, Rash
Clinical narrative: Had PCV 13 shot done 1 week ago, reports feeling feverish on the first night that resolved. Followed by dizziness and pain over whole LT arm and an itchy red rash over the LT arm. Also noted some bruising over upper arm near elbow.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Had PCV 13 shot done 1 week ago, reports feeling feverish on the first night that resolved. Followed by dizziness and pain over whole LT arm and an itchy red rash over the LT arm. Also noted some bruising over upper arm near elbow.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient has sore on L deltoid, and unable to raise his arm after get PCV13.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large silver dollar red, warm, itchy, swollen area at injection site-required doctor's visit-prescribed cephalexin 500mg tid for 7 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Mass
Clinical narrative: PER HYUSBAND, SHE HAD DEVELOPED A LUMP UNDER SKIN. SHE HAD GENERAL MALAISE FOR A FEW DAYS.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Donor walked from office to waiting area to sit down, and approximately 5 minutes after vaccine donor lost consciousness and hit her head on the floor. No signs or symptoms felt prior to losing consciousness. Donor was alert and oriented upon waking up. Donor was given ice pack for her forehead, given oral fluids and crackers.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Hypoaesthesia, Joint stiffness, Myalgia, Pain
Clinical narrative: Muscle aches. Stiffne of the joints. Numbness in injection arm. Aches and pains.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Site of injection was very swollen for 2 weeks. It took 30 days for the swelling to completely go away.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Blister
Clinical narrative: Large blisters on arm. No treatment needed.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Musculoskeletal chest pain, Pain in jaw, Vaccination site pain
Clinical narrative: Patient received Hep A #1. She felt fine. She bent forward to tie her shoe and describes pain from (R) deltoid site of vaccination that spread to (R) shoulder, ant chest wall, (R) jaw. Lasted 2 min. totally resolved.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal distension, Abdominal pain, Flatulence, Pain, Pain in jaw
Clinical narrative: Abd pain, bloating, gas, jaw pain, body aches. Sx began the day following Tdap vaccine. Sx have improved and almost resolved over last 10 days. No pharmaceutical medications at this time.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Injection site erythema, Injection site warmth
Clinical narrative: PREVNAR 13 (prefilled syringe) given on 5/7/13. A couple days later redness - warmth around area. Patient claims the redness/warmth keeps spreading as of 5/15/15, redness/warmth from injection site down to elbow. Went to immediate care facility-ROCEPHIN shot and steroid injection as well prescribed doxycycline to pt.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous pregnancy report as received from a nurse refers to a 24 year old female patient of unknown age. No concomitant medication or medical history were reported. On 01-MAY-2015, the patient was vaccinated with a dose of M-M-R II (route, lot #, and expiration ate were not reported). Concomitant medication was not reported. The reporter stated that on an unspecified date the patient found out she was pregnant. The patient's last menstrual period (LMP) was reported as 30-MAR-2015, estimated delivery date (EDD): 04-JAN-2016. The patient sought medical attention, she went to the office. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 8 patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 15-FEB2-15, 25-FEB-2015, 03-MAR-2015, 24-MAR-2015, 16-APR-2015 and 21-APR-2015, the 8 patients were vaccinated with doses of (Merck) PROQUAD, (strength, dose, frequency, route and anatomical location were not reported) (lot # K021548, expiration date 06-MAY-2016) which were improperly stored. No adverse events were reported. Additionally, it was reported that the temperature excursion for (Merck) PROQUAD was supported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB, (dose, frequency, route of administration and indication were not reported). No adverse effects reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No additional information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates in 2015, the unspecified number of patients were vaccinated with doses of LIQUID PEDVAXHIB, (strength, dose, frequency, route and anatomical location were not reported) (lot # reported as K015462, expiration date 10-JUL-2017) which were improperly exposed to 47 Fahrenheit temperature for 11 hours since an unspecified date in March 2015. No adverse events were reported. This is one of several reports received from the same reporter. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL, 120 Y (dose, frequency, route of administration and indication were not reported). No adverse effects reported. The outcome of events was unknown. No product quality complaint (PQC) was involved, No additional information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored COMVAX (dose, frequency, route of administration and indication were not reported). No adverse effects reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No additional information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. On unknown dates, multiple unspecified patients were vaccinated with RECOMBIVAX HB lot # JB12567. expiration date: 30-JUN-2016 or lot # K014548, expiration date: 27-AUG-2017, (dose, administration route and site were not reported) after it was exposed to a supported temperature excursion of 32.9F for 2 hours and 45 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report has been received from a consumer of unknown gender (Manufacturer No. 2015BAX021188) referring to him/herself. The patient had not pertinent medical history and there were no drug allergies/drug reactions reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23, (lot number, expiration date, route, dose, strength and anatomical location were not reported). No concomitant medication was reported. On an unknown date, the patient experienced pneumonia. At the reporting time, the outcome of pneumonia was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, frequency, route of administration and indication were not reported). No adverse effects reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No additional information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.59
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Rash
Clinical narrative: Red, raised bump at injection site.  Hard lump still remains at injection site. Also a strange rash has developed on his stomach.  Although the rash does not seem to bother him it has not gone away or gotten any better.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Urticaria
Clinical narrative: Patient reports large welp that is bruised on arm.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Stiffness, limping, leg pain, pain when bending knee.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site pain, Injection site reaction, Peripheral swelling, Rash macular
Clinical narrative: Soreness at injection site, soreness in armpit, red splotches around injection site, swollen hands.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation, Nausea, Tinnitus
Clinical narrative: Patient reports local irritation at site, nausea, and tinnitus.
Age: 40.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm, Ultrasound scan normal, X-ray limb normal
Clinical narrative: Swelling, erythema, and warmth of forearm; same arm as where vaccine was placed the day before.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash and slight swelling around injection site. Was tender to the touch and warm to the touch. Tenderness radiated up through shoulder and to the collar bone.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Musculoskeletal pain, Neck pain
Clinical narrative: Rash and slight swelling around injection site. Was tender to the touch and warm to the touch. Tenderness radiated up through shoulder and to the collar bone.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Rash macular
Clinical narrative: DONOR HAS MACULAR RASH TO RIGHT ARM AROUND INJECTION SITE EXPANDING APPROX 3 INCHES. DONOR DENIES HAVING ANY PAIN OR ITCHING, DONOR STATES NOT NOTICING RASH UNTIL 5/16/2015.
Age: 70.0
Sex: F
Vaccine: HEP, PNC13, TDAP, VARZOS
Symptoms: Insomnia, Pain in extremity
Clinical narrative: PATIENT COMPLAINS OF PAIN IN LEFT ARM AFTER RECEIVING BOOSTRIX AND RECOMBIVAX HB, TO THE POINT SHE HAS TROUBLE SLEEPING REPORTED TO PHARMACY 8:40PM ON 5/15/15. REFERRED TO PHYSICIAN FOR EVALUATION.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Fever; chills; redness at injection site; swelling at injection site, hands, feet. Pain at injection site.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever; chills; redness at injection site; swelling at injection site, hands, feet. Pain at injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Impaired driving ability, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Severe pain in left arm where the injection was given.  Pain began about an hour after injection and increased in severity.  Pain was so severe the first night that it interrupted sleep.  The following day the pain made it difficult to drive, conduct normal activities.  The only way to use arm was to physically lift it with the other arm, which caused enormous pain.  Pain gradually began subsiding about 48 hours after injection.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Severe pain in left arm where the injection was given.  Pain began about an hour after injection and increased in severity.  Pain was so severe the first night that it interrupted sleep.  The following day the pain made it difficult to drive, conduct normal activities.  The only way to use arm was to physically lift it with the other arm, which caused enormous pain.  Pain gradually began subsiding about 48 hours after injection.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Eczema, Gianotti-Crosti syndrome
Clinical narrative: Developed Gianotti-Crosti and has had eczema off and on since.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Skin irritation
Clinical narrative: Pt claims that 1 day after vaccination, arm felt sore and irritated.  She placed ice and took Benadryl.  She noticed that the red area was starting to spread and went to physician office.  Physician gave her abx and she says that arm redness is starting to go away.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness swelling from just below site of injection to the elbow.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, PPV, RVX
Symptoms: Crying, Dyskinesia, Peripheral coldness, Staring, Unresponsive to stimuli
Clinical narrative: Baby awoke from nap, cried, then had a blank stare and began jerking. She did not respond to any stimulation. This reaction went on for several minutes, stopped, and then began again for a minute. No fever present during this reaction, baby was cold but did not turn blue. This was witnessed by the mother, father, and both grandparents. Mother called the ER and they instructed parents to bring baby in. Baby was seen in the ER, observed for about 1 hour. No further reaction observed and baby was discharged to hom with instructions to frequently monitor baby.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Back pain, Burning sensation, Feeling abnormal, Hypersensitivity, Myalgia
Clinical narrative: Muscle pain and burning increased over 24hrs after anthrax vaccination. Pain began to migrate down right arm. Severe swelling in right arm (vaccine arm). Transported to ER and started recieving steroids in afternoon of 16th. Swelling and pain began to migrate into left arm/side/back on evening of 16th. Patient states it feels like fire ants and lava going through her veins.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Pain, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Muscle pain and burning increased over 24hrs after anthrax vaccination. Pain began to migrate down right arm. Severe swelling in right arm (vaccine arm). Transported to ER and started recieving steroids in afternoon of 16th. Swelling and pain began to migrate into left arm/side/back on evening of 16th. Patient states it feels like fire ants and lava going through her veins.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Injection site warmth, Mobility decreased, Pain
Clinical narrative: Fever, warms and swollen at site. Could barely raise arm. Fever subsides next day. Swelling pain and redness lasted for about 4 days and started going down on day 5. Did not go to or call doctor.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever, warms and swollen at site. Could barely raise arm. Fever subsides next day. Swelling pain and redness lasted for about 4 days and started going down on day 5. Did not go to or call doctor.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injection site nodule, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Initial rxn: pain at site of rxn after approximately 15 minutes. Severe itching and large know at injection site that lasted approximately 2 weeks. During the third week patient started experiencing pain and weakness radiating in waves down arm and arm pit.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Initial rxn: pain at site of rxn after approximately 15 minutes. Severe itching and large know at injection site that lasted approximately 2 weeks. During the third week patient started experiencing pain and weakness radiating in waves down arm and arm pit.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to three unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown dates, three unspecified patients were vaccinated with three additional doses of improperly stored (Merck) VARIVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-APR-2015 or 01-MAY-2015, the patient was vaccinated with either improperly stored (Merck) VARIVAX (strength, dosage, frequency and route unspecified) (Lot: reported as K015375 expiration date: 18-SEP02016, Lot: reported as K018990 expiration date: 15-OCT-2016, Lot: reported as K011317 expiration date: 13-AUG-2016, Lot: reported as K016153 expiration date: 24-SEP-2016)or improperly stored MMR II (strength, dosage, frequency and route unspecified) (Lot: reported as K021930 expiration date: 10-NOV-2016, Lot: reported as K021487 expiration date: 03-NOV-2016, Lot: reported as L001329 expiration date: 13-JAN-2017) incorrect product storage). It was unspecified exactly which lot # of the vaccine the patient was given. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female patient. Information regarding medical history and concurrent condition was not reported. ON unspecified date in 2008, the patient was vaccinated with a dose of GARDASIL (dose, strength, lot# and route were not reported). The patient received her second dose of GARDASIL on 28-JUN-12 (inappropriate schedule of drug administration), and received her third dose of GARDASIL (lot#: K008931, expiration date unspecified) on 10-APR-2015 (inappropriate schedule of drug administration). No adverse effect had been observed or reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot #, expiration date, dose and route were unknown) (Incorrect product storage). No adverse events were reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Rheumatoid arthritis
Clinical narrative: Information has been received from a 30 year old female pharmacist who was also the patient. The patient had no medical history or drug reactions/allergies. In 1995 the patient was vaccinated with (Merck) VARIVAX (dose, frequency and lot# were not reported). Concomitant therapies included lisinopril (manufacturer unknown) and LIPITOR. In 1999 the patient was diagnosed with rheumatoid arthritis. As treatment, she was prescribed ENBREL and methotrexate. Pharmacist reported she had her varicella titers drawn on 06-MAY-2015 (reported as "last week") and results showed negative antibodies. Pharmacist reported she had no immunity from the (Merck) VARIVAX. The outcome of these events was reported as not recovered/not resolved. The patient sought medical attention via seeing physician. The relationship between these events and (Merck) VARIVAX was not reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a physician regarding to a 24 year old female patient. No concurrent condition and historical medication was reported. On an unknown date, the patient was vaccinated with MMR II as a child. No concomitant medication was reported. On 17-APR-2015, the patient titers were drawn the titers showed that the patient had immuity to the MMR II, however the Measles titer came back negative. No product quality complaint was involved. The outcome of measles antibody negative was unknown. Causality between event and MMR II, live was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-APR-2015 or 01-MAY-2015, the patient was vaccinated with either improperly stored (Merck) VARIVAX (strength, dosage, frequency and route unspecified) (Lot reported as K015375 with expiration date 18-SEP-2016, Lot reported as K018990 with expiration date 15-OCT-2016, Lot reported as K011317 with expiation date 13-AUG-2016 and Lot reported as K016153 with expiration date 24-SEP-2016) or improperly stored MMR II (strength, dosage, frequency and route unspecified) (Lot reported as K021930 with expiration date 10-NOV-2016, Lot reported as K021487 with expiration date 03-NOV-2016 and Lot reported as L001329 with expiration date: 13-JAN-2017) (incorrect product storage). It was unspecified exactly which lot # of vaccine the patient was given. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician's assistance regarding a patient of unknown demographics. No concurrent condition and historical medication was reported. On 04-APR-2015, the patient was vaccinated with expired dose of M-M-R II (lot # J003787, expiration date 28-MAR-2015). No adverse event was reported. No product quality complaint was involved. The outcome of expired product administered was unknown. Causality between event and M-M-R II was unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Immediate post-injection reaction, Pruritus, Urticaria
Clinical narrative: Patient started coughing immediately after getting injection, hives to face, scratching arms. LVN notified MD, gave BENADRYL and EPI, observed for 2 hours. Patient slept for 1-1/2 hrs. Discharged by MD.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 53 year old male patient who was also a physician. The patient had no drug reactions and allergies. Information concerning medical history and concurrent conditions was not reported. On 24-MAR-2015 the patient was vaccinated with ZOSTAVAX (0.65ml, lot # K019921, expiry date: 24-JAN-2016, subcutaneous). No concomitant therapy was reported. On approximately 31-MAR-2015 (reported as "approximately 7 days later"), the patient developed a small pustular rash on both upper arms. There was no treatment given for the events. There was no lab diagnostics performed. At the time of reporting, the outcome of pustular rash was reported as not recovered. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash pustular
Clinical narrative: Information has been received from a nurse concerning a 53 year old male patient who was also a physician. The patient had no drug reactions and allergies. Information concerning medical history and concurrent conditions was not reported. On 24-MAR-2015 the patient was vaccinated with ZOSTAVAX (0.65ml, lot # K019921, expiry date: 24-JAN-2016, subcutaneous). No concomitant therapy was reported. On approximately 31-MAR-2015 (reported as "approximately 7 days later"), the patient developed a small pustular rash on both upper arms. There was no treatment given for the events. There was no lab diagnostics performed. At the time of reporting, the outcome of pustular rash was reported as not recovered. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: After receiving ZOSTAVAX vaccination, patient developed a varicella-like spot at the injection site. It is about the size of a dime. It sometimes crusts over and peels, but never heals or goes away and it itches.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Impaired healing, Injection site pruritus, Injection site reaction, Rash vesicular, Scab
Clinical narrative: After receiving ZOSTAVAX vaccination, patient developed a varicella-like spot at the injection site. It is about the size of a dime. It sometimes crusts over and peels, but never heals or goes away and it itches.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin exfoliation
Clinical narrative: After receiving ZOSTAVAX vaccination, patient developed a varicella-like spot at the injection site. It is about the size of a dime. It sometimes crusts over and peels, but never heals or goes away and it itches.
Age: 64.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Drug administration error, Injection site haemorrhage
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 64-year-old male patient who received BOOSTRIX (batch number 34EB5, expiry date 14th February 2017). On 13th May 2015, the patient received BOOSTRIX (unknown) 1 ml. On 13th May 2015, immediately after receiving BOOSTRIX, the patient experienced injection site hemorrhage. On 13th May 2015, the outcome of the injection site hemorrhage was recovered/resolved. It was unknown if the reporter considered the injection site hemorrhage to be related to BOOSTRIX. Additional details were provided as follows: Per pharmacist of a retail pharmacy, the patient was vaccinatd with a large gauge needle. Immediately following administration of BOOSTRIX, there was bleeding at the injection site. Pharmacist reported that there was no doctor involved as the injection was administered per protocol. The bleeding was resolved.
Age: 64.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 64-year-old male patient who received BOOSTRIX (batch number 34EB5, expiry date 14th February 2017). On 13th May 2015, the patient received BOOSTRIX (unknown) 1 ml. On 13th May 2015, immediately after receiving BOOSTRIX, the patient experienced injection site hemorrhage. On 13th May 2015, the outcome of the injection site hemorrhage was recovered/resolved. It was unknown if the reporter considered the injection site hemorrhage to be related to BOOSTRIX. Additional details were provided as follows: Per pharmacist of a retail pharmacy, the patient was vaccinatd with a large gauge needle. Immediately following administration of BOOSTRIX, there was bleeding at the injection site. Pharmacist reported that there was no doctor involved as the injection was administered per protocol. The bleeding was resolved.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chest X-ray, Chest discomfort, Dyspnoea, Pain in extremity
Clinical narrative: Administration arm sore, random temperature spikes, aching joints, breathing became difficult IE: settled in chest. Saw same doctor 05/09/2015, xray taken, admininstered antibiotics, prednisone and Symbicort.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Administration arm sore, random temperature spikes, aching joints, breathing became difficult IE: settled in chest. Saw same doctor 05/09/2015, xray taken, admininstered antibiotics, prednisone and Symbicort.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: Patient was admitted to the hospital for pneumonia on 4/27/15 (vaccine administered 4/9/15) - unspecified organism.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster disseminated
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a 60 year old male patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # and expiry unknown). The company representative read in the newspaper dated 14-MAY-2015, that was released on 13-MAY-2015, that a patient passed away on 11-MAY-2015, because of "complications due to a disseminated zoster virus". The representative stated that his wife overheard some unspecified individuals discussing the patient's death and mentioned that the patient had received one dose of ZOSTAVAX. Another company representative reported that a pharmacist had reported to him that the same patient had died after receiving the ZOSTAVAX. Causality of event was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: TD
Symptoms: Headache, Heart rate increased, Injection site rash, Pain, Pyrexia
Clinical narrative: Rash at inoculation site. Fever. Rapid pulse (100) at rest. Headache. Body ache.
Age: 27.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Erythema, Induration, Peripheral swelling, Pyrexia, White blood cell count increased
Clinical narrative: Patient reported right arm swelling and induration with redness and fever to 102F. Patient also had increase in WBC to 17,000 thou/mm3.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site vesicles
Clinical narrative: Pt. showed me the injection site. It looked as if she had scraped it against a wall and it was healing already on the outer parts. There was severe blistering. There was a huge fluid bubble next to the bandage that was applied after the injection.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site plaque, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Pruritic, indurated, erythematous plaque on left deltoid region at site of vaccination. Topical steroid cream applied and the cutaneous reaction subsided with 48 to 72 hours of its onset.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Malaise, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Pt reports left arm was first sore, then increasingly swollen, then she developed a fever, felt dizzy(?), and "was sick all weekend."
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Vomiting
Clinical narrative: Entire left side of body from face to feet went numb and has been numb for 4 days now. Very scary feeling so reported to doctor. Vomiting for 24 hours.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Full blood count, Rheumatoid factor
Clinical narrative: Patient began experiencing joint pain all over within a few days. Especially in joints of feet and hands.
Age: 15.0
Sex: F
Vaccine: YF
Symptoms: Blood test, Body temperature increased, Chest X-ray, Chest pain, Dizziness
Clinical narrative: Chest pain, difficulty breathing, constricted throat, nasal congestion, dizziness, red skin, slightly elevated temperature and heart rate, hives, rash.
Age: 15.0
Sex: F
Vaccine: YF
Symptoms: Dyspnoea, Electrocardiogram, Erythema, Heart rate increased, Nasal congestion
Clinical narrative: Chest pain, difficulty breathing, constricted throat, nasal congestion, dizziness, red skin, slightly elevated temperature and heart rate, hives, rash.
Age: 15.0
Sex: F
Vaccine: YF
Symptoms: Rash, Throat tightness, Urticaria
Clinical narrative: Chest pain, difficulty breathing, constricted throat, nasal congestion, dizziness, red skin, slightly elevated temperature and heart rate, hives, rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Rash erythematous
Clinical narrative: Patient presented with large red rash covering 90% of upper arm. Inflammation of the area was noticed.  Patient has been taking Ibuprofen to help with pain as well as OTC Hydrocortisone.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling cold, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection given 5/14/15. Patient c/o chills, Lt deltoid pain, heat at injection site. Redness spread to Lt shoulder and to brachial area. Started on Azithromycin 250mg. 2 tabs first day, then one daily for 2-5.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cellulitis, Emotional distress, Injection site warmth, Vaccination site nodule, Vaccination site warmth
Clinical narrative: Right leg warm and red at vaccine site. Given TYLENOL. Left leg had a knot at vaccine site. Vomiting, unconsolable. 1 day post injection. Cellulitis treated with Cephalexin (upper rt thigh). Trimethoprim given in office.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Right leg warm and red at vaccine site. Given TYLENOL. Left leg had a knot at vaccine site. Vomiting, unconsolable. 1 day post injection. Cellulitis treated with Cephalexin (upper rt thigh). Trimethoprim given in office.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Lymph node palpable, Muscle spasms, Pain in extremity
Clinical narrative: Pain on the left arm. Palpable submandibular nodes. Supraclavicular nodes. Muscle spasms. Everything on the left side.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling to thighs bilateral.