chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Middle insomnia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Very sore arm and shoulder in area of flu shot injection. More painful as hours and days and weeks went on. Can't move my right arm past 90 degrees from my side with out pain. Pain wakes me up every night since 10-16-15.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Nausea, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pain and swelling (L) arm beginning approx 2 hrs post vaccination. Pain radiating to clavicle area 2-25-16. Warm to touch - 2-25-16. Nausea - beginning 2-24-16 and continuing 2-25-16. Ice applied. TYLENOL and BENADRYL on 2-24-16 and 2-25-16.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, MNQ, TDAP
Symptoms: Abdominal pain upper, Myalgia, Nausea
Clinical narrative: Pt received his vaccinations on 1/21. He also received a penicillin G benzathin 600000U/ml (1.2 MU) IM injection that same day. On 1/22 he presented with stomach pain, nausea without vomiting, myalgias. He was given bismuth subsalicylate and acetaminophen.
Age: 15.0
Sex: M
Vaccine: FLUN4, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site plaque, Injection site warmth
Clinical narrative: Pt was given Varicella vaccination in the left deltoid on 2-16-16 and per pt's mother noticed reaction on 2-17-16 at 0730. Pt was seen at clinic on 2-17-16 and provider noted "red plaque on the left deltoid (near the varicella immunization he had yesterday) warm, firm, slightly tender to touch, no excoriation marks, no open area". Per pt's mother pt recovered fully by 2-2-16.
Age: 76.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Sore arm shoulder. Stiffness neck stiff. Unable to left arm at times.
Age: 76.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Sore arm shoulder. Stiffness neck stiff. Unable to left arm at times.
Age: 35.0
Sex: U
Vaccine: FLU3, TDAP
Symptoms: Erythema, Rash
Clinical narrative: Rash on back of neck, legs and redness of ears little on face. Patient took BENADRYL and its reducing rash.
Age: 71.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness at night in left upper arm then woke up with redness around biceps area of immunized arm measuring approx. 5 inches tall and encompassing arm, but less redness lateral arm, some swelling medial, inner aspect of arm biceps area.
Age: 61.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Rotator cuff syndrome, Ultrasound Doppler normal, X-ray limb
Clinical narrative: Needle injury. My husband and I went together to get our annual Flu shots. We noticed the pharmacist seemed clumsy while getting out supplies, but didn't know there could be a serious problem since we had never had problems with a vaccine before. The pharmacist gave me a shot first. It felt like he had done it too hard. Then he gave my husband a shot and blood was dripping down my husband's arm and the pharmacist was slow to do anything about it. When someone has been well trained or has lot of experience their movements are smooth and quick. They have the cotton ball ready to go and the bandaid, but he was klutzy. My arm hurt then but I thought it would go away in a couple of days. Instead it kept hurting so I took some OTC pain pills. Then I noticed that certain movements of my left arm (where the shot was given) hurt so much I stopped making those movements. Straight movements were ok but nothing to the side or back or up, as when putting my hair in a ponytail. I couldn't pick up my toddler grandkids anymore. I now wear shirts that button down the front because it hurts too much to put my arm thru a sleeve with an upwards and sideways motion. When I would roll onto my left side in bed it hurt, and I am a left-side sleeper. This keeps waking me up throughout the night. After 2 months of thinking it would get better on its own, thinking if he had hit a nerve there wouldn't be much that could be done anyway, I did some Internet research and found that it has been given a name: SIRVA. I read accounts of women who experienced what I was going through. I still gave it a few more weeks since some of the women said nothing had helped. Then with the pain still bad and certain movements very painful I went to see my primary care doctor. We ruled out a blood clot with an ultrasound, then after a second visit also did an xray of the left humerus, then an MRI of the humerus. This MRI showed degenerative changes of the shoulder so I then had an MRI of the shoulder. The MRI of the shoulder showed a partial thickness tear of the supraspinatus tendon. At time at my desk job I have pain up and down my arm, and I avoid the movements that are very painful. I take 5 ALEVE a day. If I don't take ALEVE even just holding my arm straight I can feel pain, sometimes a deep ache. I have to try to put my arm on an extra pillow in a certain way to try to get sleep. I use heat daily to help with the discomfort and have iced the upper arm/shoulder a few times also. A friend who is a physical therapist showed me 2 exercises/stretches to do telling me I couldn't stop using my shoulder completely or it would be even worse. I have now scheduled an appointment with an orthopedist. I don't know if I will eventually need surgery or not. This all started with the Flu shot. It was not the vaccine; it was his use of the needle. In one of the article I read it mentioned that most of the people this has happened to are women who are not very big. I weight 125 lbs. Articles about this state that the pain can last for months or years.
Age: 61.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site haemorrhage
Clinical narrative: Needle injury. My husband and I went together to get our annual Flu shots. We noticed the pharmacist seemed clumsy while getting out supplies, but didn't know there could be a serious problem since we had never had problems with a vaccine before. The pharmacist gave me a shot first. It felt like he had done it too hard. Then he gave my husband a shot and blood was dripping down my husband's arm and the pharmacist was slow to do anything about it. When someone has been well trained or has lot of experience their movements are smooth and quick. They have the cotton ball ready to go and the bandaid, but he was klutzy. My arm hurt then but I thought it would go away in a couple of days. Instead it kept hurting so I took some OTC pain pills. Then I noticed that certain movements of my left arm (where the shot was given) hurt so much I stopped making those movements. Straight movements were ok but nothing to the side or back or up, as when putting my hair in a ponytail. I couldn't pick up my toddler grandkids anymore. I now wear shirts that button down the front because it hurts too much to put my arm thru a sleeve with an upwards and sideways motion. When I would roll onto my left side in bed it hurt, and I am a left-side sleeper. This keeps waking me up throughout the night. After 2 months of thinking it would get better on its own, thinking if he had hit a nerve there wouldn't be much that could be done anyway, I did some Internet research and found that it has been given a name: SIRVA. I read accounts of women who experienced what I was going through. I still gave it a few more weeks since some of the women said nothing had helped. Then with the pain still bad and certain movements very painful I went to see my primary care doctor. We ruled out a blood clot with an ultrasound, then after a second visit also did an xray of the left humerus, then an MRI of the humerus. This MRI showed degenerative changes of the shoulder so I then had an MRI of the shoulder. The MRI of the shoulder showed a partial thickness tear of the supraspinatus tendon. At time at my desk job I have pain up and down my arm, and I avoid the movements that are very painful. I take 5 ALEVE a day. If I don't take ALEVE even just holding my arm straight I can feel pain, sometimes a deep ache. I have to try to put my arm on an extra pillow in a certain way to try to get sleep. I use heat daily to help with the discomfort and have iced the upper arm/shoulder a few times also. A friend who is a physical therapist showed me 2 exercises/stretches to do telling me I couldn't stop using my shoulder completely or it would be even worse. I have now scheduled an appointment with an orthopedist. I don't know if I will eventually need surgery or not. This all started with the Flu shot. It was not the vaccine; it was his use of the needle. In one of the article I read it mentioned that most of the people this has happened to are women who are not very big. I weight 125 lbs. Articles about this state that the pain can last for months or years.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Intussusception, Surgery, Vomiting projectile
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of intussusception in a 1-year-old male patient who received ROTARIX (batch number A41CB516A, expiry date 4th February 2017). Concomitant products included ENGERIX B pediatrics, PENTACEL and PREVNAR 13. On 6th January 2016, the patient received the 1st dose of ROTARIX (oral) 1 ml. On 22nd January 2016, 16 days after receiving ROTARIX, the patient experienced intussusception (serious criteria hospitalization, GSK medically significant, life threatening and other: as per reporter) and vomiting projectile (serious criteria hospitalization, life threatening and other: As per reporter). On an unknown date, the outcome of the intussusception and vomiting projectile were recovered/resolved. The reporter considered the intussusception and vomiting projectile to be almost certainly related to ROTARIX. Additional details were received as follows: This case was not previously reported to anyone. The patient's birth weight was 8.75 (units unknown). The patient experienced projectile vomiting and was diagnosed with intussusception. On 23rd January 2016, the patient had surgery for intussusception and was hospitalized for 3 days. The batch number reported for ENGERIX B (LL434) did not exist and was updated to LL43A as per sales database.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2015-11-02.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Computerised tomogram abnormal, Intussusception, Large intestinal obstruction reduction, Vomiting
Clinical narrative: Bilious vomiting started 2/12/16. Presented to ED 2/14/16 and diagnosed with suspected intussusception. Transfered to another hospital with ileocecal intussusception reduction performed in OR.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2015-12-16.
Age: 80.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Furuncle, Pain, Pain in extremity, Rash macular
Clinical narrative: Sore arm, within a week it hurt to extend the arm--not in shoulder joint, but upper arm, 2/22/2016, arm still hurts to move but entire upper arm turned red with several splotches.  Also had two large boils on same arm in January 2016.  Antibiotic cured one.
Age: 80.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Erythema, Furuncle, Pain, Pain in extremity, Rash macular
Clinical narrative: Sore arm, within a week it hurt to extend the arm--not in shoulder joint, but upper arm, 2/22/2016, arm still hurts to move but entire upper arm turned red with several splotches.  Also had two large boils on same arm in January 2016.  Antibiotic cured one.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Amenorrhoea, Laboratory test abnormal
Clinical narrative: Amenorrhea. Normally progressing puberty beginning age 9.  MD expected menstruation to begin at age 12.  Still no period at age 13.  Experienced one abnormally long (30 days) period at age 13.5, then no further menstruation as of age 13 years 10.5 months.
Age: 32.0
Sex: M
Vaccine: HEPAB
Symptoms: Feeling hot, Loss of control of legs
Clinical narrative: Complaints of legs "giving way," feeling very hot for brief period of time and went away. No treatment needed.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2015-10-07.
Age: 1.49
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2015-12-10.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-02-02.
Age: 33.0
Sex: M
Vaccine: MNQ, TYP, YF
Symptoms: Product preparation error
Clinical narrative: The member did not experience any adverse reaction. I realized later that I reconstituted the Yellow Fever with the normal saline instead of the sodium chloride solution provided.
Age: 1.27
Sex: F
Vaccine: DTAP, HIBV, MMRV
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of other viral vaccines, initial encounter on 2016-01-22.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Symptoms included aching, feeling nauseous, fever 101.7F oral x1.
Age: 50.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chest discomfort, Dyspnoea, Injection site pruritus, Pruritus, Throat tightness
Clinical narrative: Patient claimed she had itching in site of injection and her back, chest and then she said she has diffuclty breathing and tightness in her chest and throat heavy tongue.
Age: 50.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Tongue disorder
Clinical narrative: Patient claimed she had itching in site of injection and her back, chest and then she said she has diffuclty breathing and tightness in her chest and throat heavy tongue.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2015-12-16.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Allergy to vaccine
Clinical narrative: Allergy status to serum and vaccine status on 2015-11-30.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of other bacterial vaccines, init encntr on 2015-10-20.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Rash
Clinical narrative: Rash, bumps, redness, itchy, area became hardened.
Age: 48.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2015-10-05.
Age: 0.76
Sex: M
Vaccine: UNK
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2015-10-16.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Allergy to vaccine
Clinical narrative: Allergy status to serum and vaccine status on 2015-11-06.
Age: 1.25
Sex: M
Vaccine: MMRV, UNK
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2015-10-30.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Rash, Wheezing
Clinical narrative: Mom stated that patient started getting a rash on face then chest and back. C/o slight itching and some slight wheezing (history of Asthma. Mom gave Benadryl and said rash started to disappear, wheezing and itching stopped. Mom did not call Dr's office to report this until the next evening 2/23/2016 at approx. 5:30 PM. She was just informing us so we could put it in her record. Mom did not seem concerned. Stated at time of call that she was fine. I told Mom if any symptom returned to go to the ER for evaluation. I reported this to Dr's in office.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Mobility decreased
Clinical narrative: Pain in upper left arm immediately after injection still painful, decreased mobility.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event occurred, but patient was given an expired dose of the vaccine. He was subsequently given a viable dose.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5, UNK
Symptoms: Vaccination complication
Clinical narrative: Oth complications following immunization, NEC.
Age: 25.0
Sex: F
Vaccine: FLU4, HEP, PPV, UNK
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2015-12-09.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, UNK, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2015-12-11.
Age: 0.87
Sex: F
Vaccine: HIBV, PNC13, UNK
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2015-10-21.
Age: 66.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: Vaccination complication
Clinical narrative: Oth complications following immunization, NEC.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2015-10-17.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Dizziness, diaphoresis.
Age: 11.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Anxiety, Bacterial test negative, Bartonella test negative, Blood culture negative, CSF glucose normal
Clinical narrative: From ED notes: sudden onset decreased appetite, malaise, tense, anxious, clammy, slightly dissociated; and with visual hallucinations/metamorphosia (objects seemed to be very far away). Denies any auditory hallucinations. She started having unusual episodes lasting 1-2 minutes, described as starting with tingling in her hand followed by muscle tightness (everywhere), dizziness, blurred vision, sometimes double vision. Patient and family estimate that she had >20 such episodes on 1/28. In between, she seemed a bit slow/groggy slurred speech, but was oriented and not confused. She was staring and had a "far-off look" at times. In the ED she had an episode of head tremor "like Parkinson's".
Age: 11.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: CSF lymphocyte count increased, CSF monocyte count decreased, CSF neutrophil count negative, CSF protein increased, CSF red blood cell count positive
Clinical narrative: From ED notes: sudden onset decreased appetite, malaise, tense, anxious, clammy, slightly dissociated; and with visual hallucinations/metamorphosia (objects seemed to be very far away). Denies any auditory hallucinations. She started having unusual episodes lasting 1-2 minutes, described as starting with tingling in her hand followed by muscle tightness (everywhere), dizziness, blurred vision, sometimes double vision. Patient and family estimate that she had >20 such episodes on 1/28. In between, she seemed a bit slow/groggy slurred speech, but was oriented and not confused. She was staring and had a "far-off look" at times. In the ED she had an episode of head tremor "like Parkinson's".
Age: 11.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: CSF white blood cell count increased, Cold sweat, Computerised tomogram head normal, Cytomegalovirus test negative, Decreased appetite
Clinical narrative: From ED notes: sudden onset decreased appetite, malaise, tense, anxious, clammy, slightly dissociated; and with visual hallucinations/metamorphosia (objects seemed to be very far away). Denies any auditory hallucinations. She started having unusual episodes lasting 1-2 minutes, described as starting with tingling in her hand followed by muscle tightness (everywhere), dizziness, blurred vision, sometimes double vision. Patient and family estimate that she had >20 such episodes on 1/28. In between, she seemed a bit slow/groggy slurred speech, but was oriented and not confused. She was staring and had a "far-off look" at times. In the ED she had an episode of head tremor "like Parkinson's".
Age: 11.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Diplopia, Dissociative disorder, Dizziness, Dysarthria, Electrocardiogram normal
Clinical narrative: From ED notes: sudden onset decreased appetite, malaise, tense, anxious, clammy, slightly dissociated; and with visual hallucinations/metamorphosia (objects seemed to be very far away). Denies any auditory hallucinations. She started having unusual episodes lasting 1-2 minutes, described as starting with tingling in her hand followed by muscle tightness (everywhere), dizziness, blurred vision, sometimes double vision. Patient and family estimate that she had >20 such episodes on 1/28. In between, she seemed a bit slow/groggy slurred speech, but was oriented and not confused. She was staring and had a "far-off look" at times. In the ED she had an episode of head tremor "like Parkinson's".
Age: 11.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Enterovirus test negative, Fatigue, Gram stain negative, Hallucination, visual, Head titubation
Clinical narrative: From ED notes: sudden onset decreased appetite, malaise, tense, anxious, clammy, slightly dissociated; and with visual hallucinations/metamorphosia (objects seemed to be very far away). Denies any auditory hallucinations. She started having unusual episodes lasting 1-2 minutes, described as starting with tingling in her hand followed by muscle tightness (everywhere), dizziness, blurred vision, sometimes double vision. Patient and family estimate that she had >20 such episodes on 1/28. In between, she seemed a bit slow/groggy slurred speech, but was oriented and not confused. She was staring and had a "far-off look" at times. In the ED she had an episode of head tremor "like Parkinson's".
Age: 11.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Herpes simplex serology negative, Malaise, Metamorphopsia, Muscle tightness, Mycoplasma test
Clinical narrative: From ED notes: sudden onset decreased appetite, malaise, tense, anxious, clammy, slightly dissociated; and with visual hallucinations/metamorphosia (objects seemed to be very far away). Denies any auditory hallucinations. She started having unusual episodes lasting 1-2 minutes, described as starting with tingling in her hand followed by muscle tightness (everywhere), dizziness, blurred vision, sometimes double vision. Patient and family estimate that she had >20 such episodes on 1/28. In between, she seemed a bit slow/groggy slurred speech, but was oriented and not confused. She was staring and had a "far-off look" at times. In the ED she had an episode of head tremor "like Parkinson's".
Age: 11.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Paraesthesia, Polymerase chain reaction, Respiratory syncytial virus test negative, Somnolence, Staring
Clinical narrative: From ED notes: sudden onset decreased appetite, malaise, tense, anxious, clammy, slightly dissociated; and with visual hallucinations/metamorphosia (objects seemed to be very far away). Denies any auditory hallucinations. She started having unusual episodes lasting 1-2 minutes, described as starting with tingling in her hand followed by muscle tightness (everywhere), dizziness, blurred vision, sometimes double vision. Patient and family estimate that she had >20 such episodes on 1/28. In between, she seemed a bit slow/groggy slurred speech, but was oriented and not confused. She was staring and had a "far-off look" at times. In the ED she had an episode of head tremor "like Parkinson's".
Age: 11.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Tension, Urine analysis normal, Viral test negative, Vision blurred
Clinical narrative: From ED notes: sudden onset decreased appetite, malaise, tense, anxious, clammy, slightly dissociated; and with visual hallucinations/metamorphosia (objects seemed to be very far away). Denies any auditory hallucinations. She started having unusual episodes lasting 1-2 minutes, described as starting with tingling in her hand followed by muscle tightness (everywhere), dizziness, blurred vision, sometimes double vision. Patient and family estimate that she had >20 such episodes on 1/28. In between, she seemed a bit slow/groggy slurred speech, but was oriented and not confused. She was staring and had a "far-off look" at times. In the ED she had an episode of head tremor "like Parkinson's".
Age: 1.29
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site rash, Injection site reaction
Clinical narrative: Red, hardened lump around right upper thigh. Red splotchy rash around both upper thighs.
Age: 1.29
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash macular
Clinical narrative: Red, hardened lump around right upper thigh. Red splotchy rash around both upper thighs.
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Cough, Oropharyngeal pain, Upper-airway cough syndrome
Clinical narrative: POST NASAL DRIP, SORE THROAT, COUGH.
Age: 10.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Pruritus, Pyrexia
Clinical narrative: Patient came to clinic today at 1530 and was examined. Pt had moderate edema (from top of the deltoid region to mid arm) and erythema in L deltoid region. Noted his arm felt itchy, but did not scratch. Parents reported highest temp was last night at 39 degrees Celsius (102.2 F). Parents gave him medicine and his fever came down. Current temp 99.8 degrees Fahrenheit. Last dose of medicine given around 1400. Parents were instructed to give him Tylenol and Benadryl, weight-based dosing was explained and handout was given. Parents were instructed if the swelling or redness spreads, impaired movement, or increasingly high temps that are not relieved by medicine, please return to clinic or call urgent care.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Headache, Injection site pain
Clinical narrative: Pain at injection site, redden area, by evening 6:30PM tired, headache, continued through day 2, more pain and larger redden area.
Age: 4.0
Sex: F
Vaccine: FLUN4, MMRV
Symptoms: Eyelid rash, Rash generalised
Clinical narrative: Rash around eyes, and then spread all over body.
Age: 47.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Amnesia, Arthralgia, Asthenia, Chest pain, Dizziness
Clinical narrative: Rash, high temperature, pain in joints, exhaustion, lymph node swelling under arm and side of neck, pain in left arm, swelling over complete upper left arm injection site, headache, weakness, dizziness, chest pain, nausea, hallucinations, memory loss.
Age: 47.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Fatigue, Hallucination, Headache, Injection site swelling, Lymphadenopathy
Clinical narrative: Rash, high temperature, pain in joints, exhaustion, lymph node swelling under arm and side of neck, pain in left arm, swelling over complete upper left arm injection site, headache, weakness, dizziness, chest pain, nausea, hallucinations, memory loss.
Age: 47.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Nausea, Pain in extremity, Pyrexia, Rash
Clinical narrative: Rash, high temperature, pain in joints, exhaustion, lymph node swelling under arm and side of neck, pain in left arm, swelling over complete upper left arm injection site, headache, weakness, dizziness, chest pain, nausea, hallucinations, memory loss.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: She notice redness and soreness on injection site on 02/21/2016, appling a cold compression to the site. MD gave her Cipro 500 mg, twice a day.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Lacrimation increased, Pain in extremity
Clinical narrative: Swollen arm, fever, redness at site. Encapsulated in arm for 3 month followed by itching, arm pain, swollen arm, sneezing, watery eyes;  sore left shoulder continues with difficulty lifting left arm at shoulder.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Sneezing
Clinical narrative: Swollen arm, fever, redness at site. Encapsulated in arm for 3 month followed by itching, arm pain, swollen arm, sneezing, watery eyes;  sore left shoulder continues with difficulty lifting left arm at shoulder.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Patient developed a rash on her feet and ankles at night on 2/24/16. No treatment used.
Age: 2.0
Sex: F
Vaccine: DPP
Symptoms: Disability, Intensive care, Laboratory test, Seizure
Clinical narrative: Seizure that lasted 1 1/2 hours even when given medicine in the ER. Kept in ICU 3 days. Ended up handicapped.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Infection, Pyrexia, Vaccination complication
Clinical narrative: Was made aware of patient reaction 2/25/16. Patient says she had a fever and wasn't feeling good. She was admitted in hospital due to infection/reaction to vaccines.
Age: 1.07
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash generalised, Varicella
Clinical narrative: Information has been received from a registered nurse referring to a 13 month old male patient. There were no pertinent medical history or drug reactions/allergies. On 14-JAN-2016 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # L024252, expiration date: 30-JUN-017, dose 1, subcutaneous). Other suspect therapies included M-M-R II (dose 1, dose, lot#, expiration and route not reported) on 14-JAN-2016. There was no concomitant medication. It was reported that the patient developed a widespread rash on 07-FEB-2016. The patient was evaluated by an unspecified physician assistant on 08-FEB-2016 and was diagnosed with chickenpox. No treatment was recommended. There was no lab diagnostics studies performed. The causality was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: 2 days after vaccine (MENACTRA) in left deltoid, c/o "twitching"/muscle spasm in left arm. Having frequent muscle spasm in left arm for past 3 days. Still occurring at office visit today (2/24/16).
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Developed (R) upper leg cellulitis 24-48 hrs after Dtap and polio vaccine.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via field representative refers to a 62 year old male patient. Patient's medical history and concurrent conditions were not reported. On an unspecified date in September 2015 the patient was vaccinated with ZOSTAVAX of unspecified dose and frequency. No information on concomitant medication was provided. On an unknown date, the patient developed a raised, itchy rash extending from injection site to his elbow. The patient sought medical attention with an unspecified physician and was treated with BENADRYL. The patient recovered from the events on an unspecified date. No further information was provided. No product quality complaint (PQC) was involved. The relatedness of the event with the suspect therapy was not provided. Additional information is not expected since there is no consent to perform follow up.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-FEB-2016, the patient was inadvertently vaccinated with an expired dose of GARDASIL (lot # J012212, expiration date 18-FEB-2016; dose and route of administration were not provided). No adverse effects were reported. 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 medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-FEB-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (exact dose and route of administration were not reported, lot # reported as L045676, expiration date 09-MAY-2017). There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patients were vaccinated with improperly stored PNEUMOVAX 23, single-dose vials, lot # L019835, expiry date 23-MAR-2017. It was reported that the vaccines were exposed to temperature of 12.6 degree Celsius for 2 hours and 9 minutes because of data logger. No previous temperature excursion was reported. No adverse effect reported. 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: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patients were vaccinated with improperly stored GARDASIL 9, lot # L014415, expiry date 25-JUL-2017 and lot # L023230, expiry date 28-JUL-2017, (dose, frequency and route of administration not reported). It was reported that the vaccines were exposed to temperature of 12.6 degree Celsius for 2 hours and 9 minutes because of data logger. No previous temperature excursion reported. No adverse effect reported. 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: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 17-FEB-2016 the patient was inadvertently vaccinated with an expired dose of VAQTA (lot # K010195, expiration date 15-JAN-2016, dose and route were unknown) (Expired product administered). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 22-FEB-2016, the patient was inadvertently vaccinated with an expired dose of RECOMBIVAX HB lot # J008570, expiry date 05-FEB-2016 (dose, strength and route of administration were not reported). No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patients were vaccinated with improperly stored oral, ROTATEQ, lot # L020859, expiry date 19-JAN-2017; lot # K020181, expiry date 24-JUN-2016, (dose, frequency and route of administration not reported). It was reported that the vaccines were exposed to temperature of 12.6 degree Celsius for 2 hours and 9 minutes because of data logger. No previous temperature excursion reported. No adverse effect reported. 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: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 16-FEB-2016, the patient was administered improperly stored PROQUAD (Merck) (lot # L002420, expiration date: 23-JUL-2016, dose and route of administration were not reported). Administered dose of PROQUAD underwent temperature excursions at 4 Celsius degrees, for 18 days, from 04-FEB-2016 until 22-FEB-2016. Information about the previous temperature excursions was not reported. Data logger was not involved in this particular situation. The reporter stated that the PROQUAD (Merck) was stored improperly due to product confusion, M-M-R II and the PROQUAD (Merck) look exactly the same on the top of the box. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. Since 06-JAN-2016, an unknown number of unspecified patients have been administered doses of VAQTA lot # L030442, exp. 19-DEC-2016, L042631, exp. 16-DEC-2016 and L034381, exp. 21-DEC-2015 (dose, route and site of administration were not reported) that have been improperly stored. The temperature of the storage was 33 Fahrenheit degree for 3.5 hours. No adverse symptoms were reported. The outcome of the patient's event was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: This spontaneous report was received from a physician via field representative refers to a 16 year old female patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided. On an unknown date, the patient was vaccinated with GARDASIL. The patient experienced amneorrhoea since an unknown date after vaccination. Outcome of the event was unknown. Reporting physician did not assessed the causality of the event with respect to vaccination with GARDASIL. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 08-OCT-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016, dose, route of administration and anatomical location were not reported). No adverse symptoms were reported. The temperature excursion was due to daily vaccine counts that caused the storage unit to have temperature fluctuations because of door opening. This is one of several reports received from the same reporter. Additional information is not expected as no further follow-up is required.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Lactation disorder
Clinical narrative: This spontaneous report was received from a consumer (patient's brother) refers to a 30 year old female patient. The patient was not pregnant. Information regarding her concurrent condition, drug reactions/allergies and concomitant medication was not provided. On an unknown date two weeks after giving birth to a child, the patient was vaccinated with GARDASIL via intramuscular route. Patient reported that she felt weak after receiving the vaccination. She also reported that she could not produce enough milk to feed her child. Outcome of the events were unknown. Causality assessment was not provided. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received a registered nurse refers to a 58 year old male patient. Patient's pertinent medical history included psoriasis. Drug reactions or allergies were reported as none. On 12-FEB-2016, the patient was vaccinated with PNEUMOVAX 23 (Lot# L038669), route, dose and strength were not reported. No concomitant medications were reported. Lab tests were reported none. On 13-FEB-2016, 2 days after vaccination, the patient developed swollen hard mass at the site of injection. The reaction was red, warm and painful to touch. The patient sought medical attention and was prescribed warm packs to the affected area, as well as alternating doses of ibuprofen and TYLENOL. On 15-FEB-2016, the patient recovered from the events. The reporter did not provide causality between the events and the suspect therapy. Additional information is not expected as reporter did not give consent for follow-up.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 12-OCT-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016, albumin status HSA, dose, route of administration and anatomical location were not reported). No adverse symptoms were reported. The temperature excursion was due to daily vaccine counts that cause the storage unit to have temperature fluctuations because of door opening. This is one of several reports received from the same reporter. Additional information is not expected as no further follow-up is required.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case report was received from a registered nurse regarding unknown number of patients of unknown age and gender. No concurrent conditions  and medical histories of the patients were not reported. On an unknown date the patient was vaccinated with RECOMBIVAX HB stored outside the recommended temperature range (0.3 degree for 45 minutes) (incorrect product storage) with a lot number # of L044694 (expiry date: 04-FEB-2018), (dosing regimen, strength, route and frequency was unknown). Concomitant medications of the patients were not reported. No adverse event was reported. This is one of the several reports 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 licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history was not reported. On an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L030870, expiration date: 10-JUN-2018 (doses and routes of administration were not provided). 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: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 05-OCT-2015, the patient was vaccinated with an improperly stored dose of MMRII (rHA) status (lot # J016232, expiration date, dose, anatomical location and route of administration were not reported). The reason for the temperature excursion was, because the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information is not expected, as no further information is available.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. Patient's pertinent medical history, drug reaction/allergies and concomitant medications was not provided. On 17-FEB-2016, the patient was inadvertently administered a dose of PNEUMOVAX 23 lot # K009107, expiration date 21-JAN-2016 (strength, dose, frequency, route was not provided). It was reported that the vaccine had expired on 26-JAN-2016. There was no adverse effects reported. No product quality complaints (PQC) involved was reported. Causality assessment was not reported. No further information provided. Additional information is not expected as the reporter cannot be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. Since 06-JAN-2016, an unknown number of unspecified patients have been administered doses of RECOMBIVAX HB lot # L027733, exp. 13-SEP-2017, lot # L016959, exp. 12-MAR-2018 and lot # L045117, exp. 06-OCT-2018 (dose, route and site of administration were not reported) that have been improperly stored. The temperature of the storage was 33 Fahrenheit degree for 3.5 hours. No adverse symptoms were reported. The outcome of the patient's event was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster
Clinical narrative: Information has been received from a consumer referring to her 67 year old male fiancé. The patient's medical history and concurrent conditions were not provided. In appropriately February 2009 ("about seven years ago at 60 years of age"), the patient was vaccinated with ZOSTAVAX (dose, route and lot number not provided). The patient had an outbreak of a sporadic rash around 12-FEB-2016. His symptoms included blisters and pain on his left side, which also affected his upper back, hairline, chest and neck. The patient's fiancé said he was also experiencing headaches. The patient went to urgent care place where his condition was diagnosed as Shingles and was given famciclovir for his symptoms. The outcome of events was reported as recovering/resolving. This is one of several reports received from the same source. Additional information has been requested.