chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Impaired work ability, Injection site bruising, Injection site inflammation, Injection site pain
Clinical narrative: Patient was given a Boostrix (Tdap) vaccination and a Zostavax (shingles) vaccination in the same arm on 11/5/2015.  Patient came to pharmacy (he is an employee) to report he had experienced an adverse reaction to the Zostavax vaccine.  He had an injection-site reaction of pain, inflammation and bruising.  Patient had gone to his primary care doctor over the weekend and was given a Z-Pak as prophylactic antibiotic as well as the physician ordering him to rest and take a few days off from work.  Patient is feeling better now, but just wanted to let us know.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: Has itchy rash on forearms and front of legs @ one week after the immunization, and presented to the pharmacy 11/10/15.
Age: 94.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling cold, Tremor
Clinical narrative: Patient reported shaking and feeling cold, but no fever.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin warm, Tenderness
Clinical narrative: TENDER, ITCHY, RED, WARM RASH ON BACK OF ARM -- ABOUT 4 QUARTERS IN SIZE.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Tired, all joints ache, arm swollen and sore.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dyspnoea, Swelling face, Swollen tongue
Clinical narrative: Had swelling of tongue and face, difficulty breathing. Was driven to the Emergency Room where she received epinephrine, Benadryl, and Solumedrol.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain lower, Back pain, Blister, Flank pain, Herpes zoster
Clinical narrative: Beginning on 11/2 my back felt as though I pulled a muscle to the left of my spine. The next day my back continued to hurt and began to itch accompanied with pain around my left side to my lower abdomen. By Wednesday, red itchy bumps began to appear and turned into clusters of red, painful, blistery bumps covering my lower abdomen, left side, and along the left side of my spine, over the following days. The diagnosis of Shingles was confirmed on Monday 11/9 and treated with steroid cream along with 1gram 3x per day for 7 days of valacyclovir.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash erythematous, Rash pruritic
Clinical narrative: Beginning on 11/2 my back felt as though I pulled a muscle to the left of my spine. The next day my back continued to hurt and began to itch accompanied with pain around my left side to my lower abdomen. By Wednesday, red itchy bumps began to appear and turned into clusters of red, painful, blistery bumps covering my lower abdomen, left side, and along the left side of my spine, over the following days. The diagnosis of Shingles was confirmed on Monday 11/9 and treated with steroid cream along with 1gram 3x per day for 7 days of valacyclovir.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Shingles/Herpes Zoster Ophthalmicus.
Age: 39.0
Sex: F
Vaccine: TTOX
Symptoms: Arthralgia, Joint range of motion decreased, Pain, Sleep disorder, X-ray normal
Clinical narrative: Excruciating pain in left shoulder joint area. Reported this pain to ER on 10/18/15. Pain has continued along with decreased range of motion and high pain levels with certain actions. It is now over 3 weeks later and this continues and I can't seem to get assistance from current physician at this time as he states "these are painful vaccines". I do understand this, but this is not "normal" pain or reaction, and it should not be continuing over 3 weeks later and causing sleepless nights due to pain.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Erythema, Fatigue
Clinical narrative: REPORTED TODAY REDNESS ABOUT 4 INCHES IN DIAMETER, WEAKNESS, FATIGUE - ONSET TIME APPROXIMATE.
Age: 23.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose normal, Dizziness, Loss of consciousness, Vision blurred, Vomiting
Clinical narrative: DIZZINESS, BLURRED VISION, LOSS OF CONSCIOUSNESS, VOMITING.  HAPPENED IN THAT SUCCESSION APPROXIMATELY 5 MINUTES AFTER VACCINATION.  PARAMEDICS WERE CALLED AND BLOOD PRESSURE+GLUCOSE TAKEN.
Age: 23.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: DIZZINESS, BLURRED VISION, LOSS OF CONSCIOUSNESS, VOMITING.  HAPPENED IN THAT SUCCESSION APPROXIMATELY 5 MINUTES AFTER VACCINATION.  PARAMEDICS WERE CALLED AND BLOOD PRESSURE+GLUCOSE TAKEN.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Pruritus, Rash
Clinical narrative: REDNESS, RASH, WARMTH, ITCHING.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site vesicles, Injection site warmth
Clinical narrative: REDNESS, RASH, WARMTH, ITCHING.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Abdominal pain, Differential white blood cell count, Dizziness, Full blood count
Clinical narrative: Severe abdominal pain, severe lightheadedness, vomiting continued for 20-30 minutes and quickly subsided to slight abdominal discomfort; checked at ER, released on bland diet.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Lipase, Metabolic function test, Vomiting
Clinical narrative: Severe abdominal pain, severe lightheadedness, vomiting continued for 20-30 minutes and quickly subsided to slight abdominal discomfort; checked at ER, released on bland diet.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site haemorrhage, Pain
Clinical narrative: Bleeding, extensive bruising above and below injection site, pain.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Patient developed an itchy rash to chest and abdomen. Mom says that rash looks like hives.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Mobility decreased, Pain in extremity
Clinical narrative: Redness covering entire upper arm (from Shoulder to elbow).  Extreme pain and difficulty moving arm.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling hot, Immediate post-injection reaction, Moaning, Muscle tightness, Paraesthesia
Clinical narrative: Patient stated that he was afraid of needles.  As I administered the shot, patient starting breathing heavily and fast.  He said he felt hot and as I pulled the needle out of his arm.  He started to slump over and his eyes were still open.  I caught him in his chair to keep him from falling over and he starting to clench his hands and make a grumbling sound in his throat.  I called his name a few times and he straightened out his body for a few seconds and then looked at me and snapped out of it.  He then said he felt hot and I got a wet towel to put on his head.  Then he said his hands were tingly.  After about 5 minutes he felt better and we walked around Target to see if he felt better. He also said his last meal was at 10am that morning and he's always been very scared of needles.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Posture abnormal, Respiratory rate increased
Clinical narrative: Patient stated that he was afraid of needles.  As I administered the shot, patient starting breathing heavily and fast.  He said he felt hot and as I pulled the needle out of his arm.  He started to slump over and his eyes were still open.  I caught him in his chair to keep him from falling over and he starting to clench his hands and make a grumbling sound in his throat.  I called his name a few times and he straightened out his body for a few seconds and then looked at me and snapped out of it.  He then said he felt hot and I got a wet towel to put on his head.  Then he said his hands were tingly.  After about 5 minutes he felt better and we walked around Target to see if he felt better. He also said his last meal was at 10am that morning and he's always been very scared of needles.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reactions noted.  Client given Tdap instead of flu vaccine.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Pt. right thigh was red, hot to the touch, and swollen.  Leg also had a hard lump at injection site.
Age: 45.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: PATIENT CAME IN 11/10/2015 PRESENTING REDNESS, SWELLING AND STIFFNESS ON THE ARM WHERE SHE RECEIVED IMZ (BOOSTRIX AND FLUVIRIN). I RECOMMENDED SHE VISIT NEARBY URGENT CARE FACILITY.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Felt a lot of pain in left shoulder after tetanus shot. Went home needle injection site visible directly below acromion, really high up on shoulder. Had other injuries and hoped soreness would dissipate but 6 days later very painful and limited mobility. Feel may need to see doctor and possibly physical therapy.
Age: 57.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Unevaluable event
Clinical narrative: Flu shot.
Age: 57.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Blood creatine phosphokinase normal, Dermatitis, Full blood count normal, Injection site pain, Metabolic function test normal
Clinical narrative: Flu shot.
Age: 57.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Flu shot.
Age: 0.18
Sex: F
Vaccine: PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, Product preparation error
Clinical narrative: PENTACEL administered incorrectly. Green topped vial administered with plain sterile water diluent instead of DTaP-IPV component (blue top).
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Injection site pain, Insomnia
Clinical narrative: Severe pain at injection site/left arm, that radiated down arm, up shoulder, around chest and back shoulder, lasted 4-5 days, unable to sleep, sought treatment, cortisone shot resolved symptoms.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass
Clinical narrative: 10 days after injection pt noticed golf ball size lump at site of injection.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site rash, Injection site warmth, Pain in extremity
Clinical narrative: Arm that received the injection of PNEUMOVAX 23 (right arm) was sore and she rash on bicep and tricep area. Rash sites were warm to touch and felt harder than surrounding tissue.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Headache, Injection site erythema, Pyrexia, Urticaria
Clinical narrative: 11/05 Adm 6pm, in 2hrs fever, headache, redness at site lack of energy, local urticaria extending down right arm.
Age: 0.59
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Dyskinesia, Injection site abscess, Injection site cellulitis, Seizure, Tic
Clinical narrative: Convulsions - tics - jerking non purposeful movements. (L) leg cellulitis/abscess.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: After the patient received the vaccination, she experienced persistent itching all over her body that has endured for over 2 weeks.
Age: 33.0
Sex: U
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: Patient received vaccine on 11/10/15 stating that she had a shoulder pain that wouldn't go away and thinks that it is due to the vaccine being administered too high up on her shoulder.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 4 days, redness and itching at injection site. Patient is improving.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: Pain, which initiated within few days after vaccination and still present a few week out after vaccines were administered. (Pain/soreness on arm which they were given). (Left and right).
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: Pain, which initiated within few days after vaccination and still present a few weeks out after vaccines received/were administered (pain/soreness on arm which they were given). (Left and right).
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain, which initiated within few days after vaccination and still present a few weeks out after vaccine was received/administered (pain/soreness on arm vaccine was given).
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain, which initiated within few days after vaccination and still present a few weeks out after vaccine was administered. (Pain soreness on arm which vaccine was given).
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Pain, which initiated within few days after vaccination and still present a few weeks out after vaccine(s) were administered. (Pain/soreness on arm which vaccines were given).
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Pt parent reported that pt was having a difficult time breathing/wheezing. Triage nurse scheduled f/u appt for 11/10 (9:15am) as no immediate need/stress. MD administered albuterol (0.083%)
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: Pt presented with redness, swelling of right arm. Pt's arm had yellow crusting. When band aid removed a small area of skin bled and oozing occurred. Treated for cellulitis. Ibuprofen and antibiotics issued.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Urticaria
Clinical narrative: Hives appeared a few hours later. Patient also complained of scratchy throat. She self treated w/BENADRYL and was prescribed MEDROL dose pack. By 11/18/15 she is 90% better.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint stiffness
Clinical narrative: Pt complained of pain and stiffness in elbow joint approximately 5 min after injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Blister, Erythema, Induration, Local reaction
Clinical narrative: Initially had localized reaction with redness and induration. Then developed large blister (approx 3-4 cm) in area.
Age: 31.0
Sex: M
Vaccine: ANTH, HEP, HEPA, MMR, SMALL, TTOX, TYP
Symptoms: Anxiety, Bipolar disorder, Blood cholesterol increased, Depression, Gastrooesophageal reflux disease
Clinical narrative: Acid Reflux Disease. Anxiety. Below Average Intelligence. Bipolar. Depression. High Blood Pressure. High Cholesterol. Psychological Disorder. Migraine.
Age: 31.0
Sex: M
Vaccine: ANTH, HEP, HEPA, MMR, SMALL, TTOX, TYP
Symptoms: Hypertension, Mental disorder, Mental impairment, Migraine
Clinical narrative: Acid Reflux Disease. Anxiety. Below Average Intelligence. Bipolar. Depression. High Blood Pressure. High Cholesterol. Psychological Disorder. Migraine.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Chromaturia, Decreased appetite
Clinical narrative: 2 days post-injection of FLUZONE High Dose vaccine, I developed severe weakness, muscle and joint pain, headache, high fever, chills, complete loss of appetite, dark urine, sleepiness, and lethargy. Although some of the symptoms have alleviated spontaneously, after nearly a week they still persist in a lesser form. None of these symptoms developed with previous flu vaccinations in recent years.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Lethargy, Myalgia, Pyrexia, Somnolence
Clinical narrative: 2 days post-injection of FLUZONE High Dose vaccine, I developed severe weakness, muscle and joint pain, headache, high fever, chills, complete loss of appetite, dark urine, sleepiness, and lethargy. Although some of the symptoms have alleviated spontaneously, after nearly a week they still persist in a lesser form. None of these symptoms developed with previous flu vaccinations in recent years.
Age: 73.0
Sex: U
Vaccine: FLU3
Symptoms: Fatigue, Malaise, Nausea, Retching
Clinical narrative: I had the super flu shot on 11.02.15. That night I got very sick...nauseated and huge fatigue that has lasted until today, 11.04.15. My physician prescribed nausea suppositories but I still am not feeling well. Not as nauseated but had dry heaves last night...as no food in my stomach. I'm concerned that for seniors (I am 73 years old), this super flu shot can be very very dangerous and there should be much  more warning. Pharmacy sort of blew it off when I called say it was very rate. I've spoken with several friends who have had the same reaction. I believe better and more information and warning up front should be made available to consumers.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Vaccinated on 11/2/15 - on 11/9/15 - mother noticed site of varicella to be dark red, warm to touch measuring - 3/4 inch by 5/8 inch (L) lateral thigh - child very playful and no temperature.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram normal, Oropharyngeal pain, Throat tightness
Clinical narrative: Patient received AFLURIA at PCP office on 11-09-15 at 1402. At 2020 patient presented to ER with tightness/pain in throat. At 2045 pain was gone, lungs clear, EKG normal sinus rhythm, no block no ST changes. No angioedema. Can swallow without difficulty. No rash noted. Prescribed hydroxyzine 25mg q 4h x2 days.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Informations has been received from a registered nurse referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates in September 2015 the unspecified patients were vaccinated with 4 doses of improperly stored PROQUAD (Merck) (lot # L026728, expiration date 15-JAN-2017) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse symptoms was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 61 year old female patient. The patient's concurrent conditions and medical history were not provided. On 29-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX, vial, intramuscular injection, 0.65 ml, once, in the arm ("assuming into deltoid"). Concomitant therapies included an unspecified "birth control" medication. On an unspecified date, in 2015, the patient arm (at the injection site) was red, swollen and warm to touch. On 04-NOV-2015, the patient contacted the pharmacy for medical attention. There were no laboratory studies performed. The pharmacist was asking for treatment recommendations for the patient as no treatment had been employed yet. There was no product quality issue involved. At the time of the report, the outcome of injection site warmth, injection site swelling and injection site erythema was reported as not recovered. The reporter did not assess the relatedness of injection site warmth, injection site swelling and injection site erythema with ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis, Rotavirus test positive
Clinical narrative: Information has been received from the authors in a published literature article regarding a child patient of unknown age and gender, who in 2007 received a complete vaccination regimen of 3 doses of ROTATEQ (dose and route were not reported). ROTATEQ is a pentavalent human bovine reassortant vaccine that contains 4 G types (G1, G2, G3, and G4; VP7 gene) plus the P[8] VP4 type on a bovine WC3 (G6P[5]) backbone. On an unknown date, in the child with acute gastroenteritis was identified an NSP2 gene ROTATEQ in an RVA with a DS-1 like genotype (adverse event). Although the child from whom the NSP2 reassortant specimen was obtained had been vaccinated with a complete regimen of 3 doses and no other rotavirus vaccine, ROTATEQ genes was detected in the fecal sample. Finally, the finding of strain RVA/human-wt/USA/2011729115/2011/G2P[4], a wild-type RVA with a vaccine-derived NSP2 gene, in a child with acute gastroenteritis highlights the need for continued rotavirus surveillance, domestically and internationally, after vaccine introduction. The outcome of gastroenteritis and NSP2 gene ROTATEQ in an RVA with a DS-1 like genotype was unknown. The reporter considered the events to be related to ROTATEQ. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 23-OCT-2014, the patient was vaccinated with the first dose of GARDASIL (lot #, route and expiration date were not reported). On 11-SEP-2015, the patient received the second dose and, on 26-OCT-2015, received the third dose of GARDASIL lot # K016966, expiration date 10-MAY-2017. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Abnormal behaviour, Aggression, Anxiety, Developmental regression, Disturbance in attention
Clinical narrative: Behavioral changes. Patient had flu vaccination (FLUMIST) administered Wednesday October 28, 2015. We have seen the following incidents during the week: Thursday October 29, 2015 patient develops a cold, temperature (99F), sneezing, stuffy nose; Friday October 30, 2015 Incident reported from School transportation driver about patient getting aggressive and behaving not safe so he had to be transported back to school. Saturday October 31, 2015 patient is more unfocused than unusual, crawling during part of the day, was getting on his hands on the ground. Seemed aloof, not listening to parent's voices. Sunday November 1st, 2015 He is very hyperactive at home, crashing against the walls, unable to seat or stay still. Monday November 2nd, 2015 Incident reported from school. Patient gets very aggressive towards teacher. Biting, bolting. This incident is being investigated. Tuesday November 3rd, 2015 Incident at Speech therapy. Aggressive behavior, bolting, meltdown. This never happened before in 8 years he is being attending this place. Wednesday November 4th, 2015 We visit the library, patient was unable to sit, unfocused, anxious, repetitive behaviors, fast speech. Far from his usual attitude at the library, he did not even acknowledge the librarian which he always does. Thursday November 5th, 2015 Patient wandered away from the house. He was found walking down the street towards downtown half a mile away from our home. He had wondered before around our property (2 acres) but he had never left premises before. Patient is a 10 year old boy with autism who was doing significant progress at school and at home. During this week following the administration of the flu vaccine patient has shown regression in all areas of development along with aggressive behaviors. It is reasonable to suspect that the FLUMIST had caused a severe allergic reaction that have changed his behaviors and I want this to be reported to CDC for investigation.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Emotional distress, Hypersensitivity, Indifference, Nasal congestion, Nasopharyngitis
Clinical narrative: Behavioral changes. Patient had flu vaccination (FLUMIST) administered Wednesday October 28, 2015. We have seen the following incidents during the week: Thursday October 29, 2015 patient develops a cold, temperature (99F), sneezing, stuffy nose; Friday October 30, 2015 Incident reported from School transportation driver about patient getting aggressive and behaving not safe so he had to be transported back to school. Saturday October 31, 2015 patient is more unfocused than unusual, crawling during part of the day, was getting on his hands on the ground. Seemed aloof, not listening to parent's voices. Sunday November 1st, 2015 He is very hyperactive at home, crashing against the walls, unable to seat or stay still. Monday November 2nd, 2015 Incident reported from school. Patient gets very aggressive towards teacher. Biting, bolting. This incident is being investigated. Tuesday November 3rd, 2015 Incident at Speech therapy. Aggressive behavior, bolting, meltdown. This never happened before in 8 years he is being attending this place. Wednesday November 4th, 2015 We visit the library, patient was unable to sit, unfocused, anxious, repetitive behaviors, fast speech. Far from his usual attitude at the library, he did not even acknowledge the librarian which he always does. Thursday November 5th, 2015 Patient wandered away from the house. He was found walking down the street towards downtown half a mile away from our home. He had wondered before around our property (2 acres) but he had never left premises before. Patient is a 10 year old boy with autism who was doing significant progress at school and at home. During this week following the administration of the flu vaccine patient has shown regression in all areas of development along with aggressive behaviors. It is reasonable to suspect that the FLUMIST had caused a severe allergic reaction that have changed his behaviors and I want this to be reported to CDC for investigation.
Age: 10.0
Sex: M
Vaccine: FLUN4
Symptoms: Psychomotor hyperactivity, Restlessness, Sneezing, Stereotypy
Clinical narrative: Behavioral changes. Patient had flu vaccination (FLUMIST) administered Wednesday October 28, 2015. We have seen the following incidents during the week: Thursday October 29, 2015 patient develops a cold, temperature (99F), sneezing, stuffy nose; Friday October 30, 2015 Incident reported from School transportation driver about patient getting aggressive and behaving not safe so he had to be transported back to school. Saturday October 31, 2015 patient is more unfocused than unusual, crawling during part of the day, was getting on his hands on the ground. Seemed aloof, not listening to parent's voices. Sunday November 1st, 2015 He is very hyperactive at home, crashing against the walls, unable to seat or stay still. Monday November 2nd, 2015 Incident reported from school. Patient gets very aggressive towards teacher. Biting, bolting. This incident is being investigated. Tuesday November 3rd, 2015 Incident at Speech therapy. Aggressive behavior, bolting, meltdown. This never happened before in 8 years he is being attending this place. Wednesday November 4th, 2015 We visit the library, patient was unable to sit, unfocused, anxious, repetitive behaviors, fast speech. Far from his usual attitude at the library, he did not even acknowledge the librarian which he always does. Thursday November 5th, 2015 Patient wandered away from the house. He was found walking down the street towards downtown half a mile away from our home. He had wondered before around our property (2 acres) but he had never left premises before. Patient is a 10 year old boy with autism who was doing significant progress at school and at home. During this week following the administration of the flu vaccine patient has shown regression in all areas of development along with aggressive behaviors. It is reasonable to suspect that the FLUMIST had caused a severe allergic reaction that have changed his behaviors and I want this to be reported to CDC for investigation.
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician concerning a female patient of unknown age. On 22-OCT-2014 the patient was vaccinated with the third dose of GARDASIL (0.5 ml, lot number and expiration date not reported) intramuscularly. On 01-NOV-2014 the patient was determined to be 6 weeks pregnant. The patient became pregnant with last menstrual period (LMP) of 20-SEP-2014 and estimated delivery date (EDD) of 27-JUN-2015. Initial exposure to GARDASIL was at 4 week. The pregnancy outcome was outcome pending. The patient sought medical attention by visiting the office on an unknown date. Follow up information has been received from the reporting physician on 09-NOV-2015. The physician reported that the patient decided to have an elective termination on an unspecified date of 2014 (reported as between 6 to 8 weeks of pregnancy). The outcome of effective termination pregnancy was unknown. Causality was not provided. Upon internal review elective termination pregnancy was considered as medically significant. Additional information has been requested. Pregnancy outcome, event and narrative were updated.
Age: 39.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Dysphagia, Eyelid oedema, Rash macular, Rash pustular
Clinical narrative: Stevens Johnson Syndrome requiring hospitalization from 10/8/15 - 11/2/2015.
Age: 39.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Stevens Johnson Syndrome requiring hospitalization from 10/8/15 - 11/2/2015.
Age: 60.0
Sex: M
Vaccine: PPV, TDAP, VARZOS, PPV, TDAP, VARZOS
Symptoms: Influenza like illness, Muscle spasms, Rash
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative regarding a female patient of unknown age, The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX and a dose of PNEUMOVAX 23, (dose, route, anatomical location, lot number and expiration date were not reported for the two vaccine above described). Other suspect therapies included DTAP, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On an unknown date, the patient experienced severe rash on her arm and flu-like symptoms. The patient also experienced severe muscle aches and spasms in upper back. At the time of the report, the outcome of the experienced severe rash on her arm, flu-like symptoms, severe muscle aches and spasms in upper back was unknown. The relatedness between the events and therapy with ZOSTAVAX, PNEUMOVAX 23 and DTAP was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV, TDAP, VARZOS, PPV, TDAP, VARZOS
Symptoms: Influenza like illness, Muscle spasms, Myalgia, Rash
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative regarding a female patient of unknown age, The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX and a dose of PNEUMOVAX 23, (dose, route, anatomical location, lot number and expiration date were not reported for the two vaccine above described). Other suspect therapies included DTAP, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On an unknown date, the patient experienced severe rash on her arm and flu-like symptoms. The patient also experienced severe muscle aches and spasms in upper back. At the time of the report, the outcome of the experienced severe rash on her arm, flu-like symptoms, severe muscle aches and spasms in upper back was unknown. The relatedness between the events and therapy with ZOSTAVAX, PNEUMOVAX 23 and DTAP was not reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Swelling
Clinical narrative: This spontaneous report was received from a 74 year old female patient reporting on herself with allergy to sulfa. The patient's medical history was not provided. On 07-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not provided). Concomitant therapies included Verapamil. On 10-OCT-2015, after the patient received ZOSTAVAX, she experienced swelling and inflammation that was warm to the touch. The patient stated that she developed pain and had lumps around the injection site. The patient was treated with prednisone. It was unknown if lab diagnostic studies were performed. At the time of the report the outcome of the events were unknown. The patient sought medical attention through an office visit. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inflammation, Injection site mass, Injection site pain, Skin warm, Swelling
Clinical narrative: This spontaneous report was received from a 74 year old female patient reporting on herself with allergy to sulfa. The patient's medical history was not provided. On 07-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not provided). Concomitant therapies included Verapamil. On 10-OCT-2015, after the patient received ZOSTAVAX, she experienced swelling and inflammation that was warm to the touch. The patient stated that she developed pain and had lumps around the injection site. The patient was treated with prednisone. It was unknown if lab diagnostic studies were performed. At the time of the report the outcome of the events were unknown. The patient sought medical attention through an office visit. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Conjunctival hyperaemia, Eye swelling, Urticaria, Wheezing
Clinical narrative: Coughing, Sneezing, Watery Eyes and Nose, Stomach Ache, Difficulty Breathing got progressively worse. Gave ProAir Albuterol Inhaler and called dr. Then gave 1 1/2 Tsp Benadryl.
Age: 7.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Cough, Dyspnoea, Lacrimation increased, Rhinorrhoea
Clinical narrative: Coughing, Sneezing, Watery Eyes and Nose, Stomach Ache, Difficulty Breathing got progressively worse. Gave ProAir Albuterol Inhaler and called dr. Then gave 1 1/2 Tsp Benadryl.
Age: 7.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Sneezing
Clinical narrative: Coughing, Sneezing, Watery Eyes and Nose, Stomach Ache, Difficulty Breathing got progressively worse. Gave ProAir Albuterol Inhaler and called dr. Then gave 1 1/2 Tsp Benadryl.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Injection site warmth, Rash papular
Clinical narrative: On 11/3/15, 76 yo M presented to clinic for annual exam. During this visit, pt was ordered and administered Pneumococcal Conjugate 13-Valent (Prevnar 13) vaccine 0.5 mL in right deltoid (NDC #0005-1971-01, Lot #m13068, Exp: 4/1/2017). Pt tolerated injection without incident and was discharged home in stable condition. On 11/10, one week after the injection, pt called the clinic and reported that he may be having a site reaction to the pneumonia vaccine. Pt returned to clinic for exam and MD found a very faint papular rash present at the injection site which was mildly warm. MD stated "likely mild reaction to Prevnar". Pt was advised to use Claritin (loratadine) and ice to the area as needed. Pt was discharged home with these instructions.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pain, Skin tightness, Skin warm, Swelling
Clinical narrative: Acute pain and swelling. Skin is red, tight and hot to the touch.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Fatigue, Myalgia, Posture abnormal
Clinical narrative: Excessive fatique, unable to hold head up, severe muscle soreness, very uncomfortable.
Age: 1.59
Sex: F
Vaccine: FLU3, HEP, HEPA
Symptoms: Crying, Irritability, Poor feeding infant, Poor quality sleep
Clinical narrative: Mom reports child was irritable, poor feeding, poor sleeping, crying - all for 2 weeks child was not seen during this time - mom reported this 4 weeks later.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Rash erythematous, Rash generalised, Rash macular, Urticaria
Clinical narrative: Rash - red, splotchy over whole body - urticaria vaccine site was fine - no swelling or tenderness.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 25-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly (lot #, expiration date were not reported). At the time of the report the patient was in the pharmacy to be administered the second dose of the series and would be administered GARDASIL 9 0.5 ml, intramuscularly, lot # L006406, expiration date 24-FEB-2017. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) referring to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L011846, expiration date 16-JUN-2017, dose and route were not reported). No adverse effects were reported. This is one of two reports received from same reporter. Follow up information has been received on 30-OCT-2015 that all telephone attempts to obtain follow-up information had been unsuccessful. Additional information has been requested. Narrative was updated. A new case # 1511USA001527 with correct aware date was created as it was determined that a case # 1509USA007962 was sent to distribution with an incorrect aware date.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified patients of unknown age and gender. On unknown dates, since 01-OCT-2015, the patients were vaccinated with doses of RECOMBIVAX HB (lot # K010535, expiration date 27-AUG-2016; lot # K014548, expiration date 27-AUG-2016, dose unknown) that were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified patients of unknown age and gender. On unknown dates, since 01-OCT-2015, the patients were vaccinated with doses of ROTATEQ (lot # K024700, expiration date 30-JUL-2016, dose unknown) that were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot 3 L024125, expiration date 30-DEC-2016, dose and route unknown). This is one of several report received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Informatoin has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L011846, expiration date 16-JUN-2017, dose and route unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patiens were vaccinated with improperly stored doses of PEDVAXHIB (lot # L014427, expiration date 09-MAR-2018, dose and route unknown). 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: Information has been received from a medical assistant referring to a patient of unknown age and gender. On an unknown date the patient was inadvertently vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L001456, expiration date: 22-OCT-2016, route and dose were unknown), by an unspecified physician. No adverse reaction was reported. Additional information is not expected as there was no reporter's contact information.
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 18 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was not reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB (10/1.0 Mcg/ml, 1.0 ml; frequency and route unspecified) (overdose and inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via a field employee referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, strength and route unknown). 3 to 5 days after the vaccination, the patient experienced redness, itching and swelling at the injection site. No rash was present. The patient was administered BENADRYL for treatment and would be going back to the pharmacy on 06-NOV-2015 for follow up. The outcome of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Somnolence
Clinical narrative: Information has been received from a healthcare worker referring to an adolescent male patient of unknown age. No relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with GARDASIL (lot#, expiration date, dose and route not reported). On an unknown date the patient experienced "oversleepiness: since receiving unspecified dose in GARDASIL series. The outcome of the event was not recovered. The mother of the patient contacted the doctor's office to seek medical attention. Causality assessment was not reported. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old patient of unknown gender. Information regarding relevant medical history and concurrent condition were not reported. On 09-NOV-2015 the patient was inadvertently vaccinated with an expired dose of PROQUAD (Merck) (lot # K006770, expiration date 07-NOV-2015, dose and route not reported) as first dose. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, drug reactions or allergies was provided. On unspecified date, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) lot # L004652, expiration date 11-FEB-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, drug reactions or allergies was provided. On unspecified dates, the patients received two improperly stored doses of RECOMBICAX HB lot # K021444, expiration date 17-SEP-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Thiis spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concurrent conditions, drug reactions or allergies was provided. On unspecified dates, the unspecified number of patients received two improperly stored doses of oral, ROTATEQ one dose with lot # L008578 and expiration date 14-DEC-2016 and one dose with lot # L008034 and expiration date 05-AUG-2016, route defaulted to oral (dose was not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates in August 2015 the unspecified patients was vaccinated with two doses of improperly stored VARIVAX (Merck) (lot # K018144, expiration date 10-APR-2016). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a currently 3 year old male patient. There were no concomitant medications, concurrent conditions and medical history reported. The patient did not have any drug reactions and allergies. On 22-JUN-2015, the patient was vaccinated with PNEUMOVAX 23 lot # K020215 (route and site of administration, dose and expiration date were not reported). On an unknown date in 2015, after receiving PNEUMOVAX 23, the patient had gross redness on arm. The patient was treated with BENADRYL. He sought medical attention via a phone call to physician. The outcome of injection site erythema was reported as recovered/resolved on an unknown date in 2015. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L016428, expiration date 30-JUL-2017 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.