chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal distension, Abdominal pain upper, Arthralgia, Flatulence, Headache
Clinical narrative: 7/20/13 headaches, joint pain, bloating, gas, stomach pain. Continues to present.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Chest pain, Cold sweat, Fatigue, Injection site pain
Clinical narrative: Fever (101 degrees F) since vaccine administered; extreme fatigue; nausea; swelling in left upper arm with pain in left shoulder, into neck, left armpit and chest and across left shoulder blade; body aches; on 8/9/13 - (2) episodes of near syncope with clammy skin.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Musculoskeletal pain, Nausea, Neck pain, Pain
Clinical narrative: Fever (101 degrees F) since vaccine administered; extreme fatigue; nausea; swelling in left upper arm with pain in left shoulder, into neck, left armpit and chest and across left shoulder blade; body aches; on 8/9/13 - (2) episodes of near syncope with clammy skin.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Presyncope, Pyrexia
Clinical narrative: Fever (101 degrees F) since vaccine administered; extreme fatigue; nausea; swelling in left upper arm with pain in left shoulder, into neck, left armpit and chest and across left shoulder blade; body aches; on 8/9/13 - (2) episodes of near syncope with clammy skin.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Joint swelling, Pyrexia, Urticaria
Clinical narrative: 48 hours post vaccine administration pt. developed urticaria, fever, and joint swelling. Probable SSLR.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: Per patient's mother pt had hives for approx. 24 hours on and off after vaccine given. He was given PO BENADRYL with relief. He had the same type of Rx when he received his 1st varicella per mother but since has grown out of egg allergy so mom wanted vaccine given.
Age: 1.52
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever up to 103.9 x 4 days.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Nausea, Pallor
Clinical narrative: Noted leaning to side in waiting room, c/o nausea and dizzy when approached. Incontinent of urine, pale, diaphoretic, emesis on way to lie down. P48 initially once lying - up to 52 with BP 86/46 within 5 minutes. Pillows under knees, frequent vital signs home at 4:20 PM. Mom driving, brief loss of consciousness just before laid down.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary incontinence, Vomiting
Clinical narrative: Noted leaning to side in waiting room, c/o nausea and dizzy when approached. Incontinent of urine, pale, diaphoretic, emesis on way to lie down. P48 initially once lying - up to 52 with BP 86/46 within 5 minutes. Pillows under knees, frequent vital signs home at 4:20 PM. Mom driving, brief loss of consciousness just before laid down.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling abnormal, Mobility decreased, Pruritus, Swelling
Clinical narrative: Patient reports 8 inches of redness, swelling and itching. Patient states "I felt horrible for 2 days and could barely lift my arm,"
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Paraesthesia
Clinical narrative: From navel to middle of back, she has a severe tingling sensation, but there is no shingles rash. She felt the tingling before the shot, but it became much more severe after the shot. Dr prescribed gabapentin.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Emotional distress, Pain, Rash erythematous, Skin warm
Clinical narrative: Rubar, calor, dolor all present in her rash, which appeared w/ in one day of vaccine. Patient is distressed.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site rash, Pain
Clinical narrative: 6/20/13 sore day of. 6/21/13 rash, red and purple spotted size of a baseball at injection site.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Breath holding, Grand mal convulsion, Immediate post-injection reaction
Clinical narrative: Immediately after receiving vaccines, pt was holding breath. Pt had a full body tonic-clonic seizure that lasted 5 seconds. Pt came out of seizure by self and was immediately alert and responsive. Dr at bedside. Observed pt for 30 min post seizure. No further seizure activity noted. Mom stated pt acting normally. Dr aware.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Walnut size or golf ball size knot at injection site, warm to touch and red. Noticed on 8/11/13, upon wakening. (L) deltoid. Watery diarrhea 8/12/13 at 7:00 am. Severe headache 8/11/13 at 8:00 pm.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Fall, Gait disturbance, Limb injury, Nausea, Syncope
Clinical narrative: About 5 minutes after MENVEO administered, patient stated she began to feel nauseous. She stumbled on way to bathroom (although told not to get up if she felt ill) and fell faint on the way, falling and hitting her arm.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Full blood count, Injection site erythema, Local reaction
Clinical narrative: Localized erythema at site of injection 4 x 14 cm of the PNEUMOVAX.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Adverse reaction, Vomiting
Clinical narrative: Administered 2m vaccines, mom states the rota (ROTATEQ) vaccine induced vomiting. However 4m vaccines administered minus ROTATEQ ended on same results. Mom wanted to be report as adverse reaction.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Headache, Local swelling
Clinical narrative: Pt says her arm swole up. Her under arm got red, her joints hurt and she had a headache. This lasted a week she says.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising
Clinical narrative: Patient stopped in to inquire on the bruise she developed on the site of injection area. The bruise was about 4" x 5" diameter. She was instructed to contact her primary physician 1st thing Monday morning.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Body temperature increased, Hallucination, visual
Clinical narrative: Given vaccines 8/9/13 approx 11:30AM. Midnight following administration of vaccines had 102 temp. and was hallucinating - seeing things that weren't there.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Some redness, pain and swelling at injection site. Counseled to use ibuprofen or acetaminophen for pain, BENADRYL or loratadine for any itching and hydrocortisone topically.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Fever up to 105 and whole limb swelling left thigh to knee.
Age: 1.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying
Clinical narrative: Crying greater than 3 hours, treatment ibuprofen oral 10mg/kg x1 dose.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt has pain swelling in left deltoid area. Warm and pink for 5 cm x 6 cm.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Allergic respiratory symptom, Diarrhoea, Nasal congestion, Rhinorrhoea, Sneezing
Clinical narrative: At 11 AM patient began having a miserable sinus reaction to the shot. He was having the usual allergy symptoms of sneezing, runny nose, and extreme nasal congestion. This lasted about 24 hours. At 7:00 PM patient began having diarrhea that lasted about 8 hours also. Although both of these are not life threatening we wanted to report them because these are not commonly listed and patient would have missed school for these effects.
Age: 56.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: A couple of hours after the vaccination my left arm, the site of the vaccination, became very painful and had limited range of motion.  For two days I could not lift my arm above my waist.  Finally on Monday 7/29 my arm returned to normal.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Convulsion, Cyanosis, Decreased appetite, Electroencephalogram abnormal, Gaze palsy
Clinical narrative: Child began exhibiting signs of seizure 2 hours after vaccine administered (07/22/2013).  His body stiffened, his eyes rolled and his nose and lips turned blue.  Called the doctor and doctor advised does of Tylenol and to call again if the condition persisted.  Child was drowsy and lost appetite for the following day until had another seizure on 07/24/2013 and was brought to the hospital around 6:30pm.  Child was admitted to the hospital following tests in the emergency room and after an EEG was diagnosed with infantile spasms on 07/26/2013 and discharged from the hospital with a treatment of prednisone and a followup EEG to be performed on 08/06/2013.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Infantile spasms, Musculoskeletal stiffness, Somnolence
Clinical narrative: Child began exhibiting signs of seizure 2 hours after vaccine administered (07/22/2013).  His body stiffened, his eyes rolled and his nose and lips turned blue.  Called the doctor and doctor advised does of Tylenol and to call again if the condition persisted.  Child was drowsy and lost appetite for the following day until had another seizure on 07/24/2013 and was brought to the hospital around 6:30pm.  Child was admitted to the hospital following tests in the emergency room and after an EEG was diagnosed with infantile spasms on 07/26/2013 and discharged from the hospital with a treatment of prednisone and a followup EEG to be performed on 08/06/2013.
Age: 58.0
Sex: F
Vaccine: RAB
Symptoms: Cognitive disorder, Dissociation, Dry mouth, Energy increased, Feeling abnormal
Clinical narrative: Reaction from this and subsequent shots at facility:  flat affect, disassociation with body, trouble walking, "rubbery boned", feeling like I was shaking when I was not, surges of energy both horizontally and vertically in my arms and legs, cognitive dullness, mood swings, dry mouth, extreme lethargy.
Age: 58.0
Sex: F
Vaccine: RAB
Symptoms: Flat affect, Gait disturbance, Lethargy, Mood swings, Muscular weakness
Clinical narrative: Reaction from this and subsequent shots at facility:  flat affect, disassociation with body, trouble walking, "rubbery boned", feeling like I was shaking when I was not, surges of energy both horizontally and vertically in my arms and legs, cognitive dullness, mood swings, dry mouth, extreme lethargy.
Age: 56.0
Sex: M
Vaccine: DTAP, IPV, JEV1
Symptoms: Rash generalised
Clinical narrative: Diffuse rash on face and body.  Began on face. Scalp, neck, chest, abdomen, back, extremities, and palms involved. Clinic visit 08/12/2013
Age: 23.0
Sex: M
Vaccine: HEPA, SMALL, TDAP, HEPA, SMALL, TDAP
Symptoms: Ankylosing spondylitis, Arthralgia, Back pain, Cytogenetic analysis abnormal, Laboratory test normal
Clinical narrative: Severe low back pain, intermittent paralysis, severe joint pain. All diagnosed as ankylosing spondylitis.  Treatment is Lortab, Meloxicam and muscle relaxers.
Age: 23.0
Sex: M
Vaccine: HEPA, SMALL, TDAP, HEPA, SMALL, TDAP
Symptoms: Paralysis
Clinical narrative: Severe low back pain, intermittent paralysis, severe joint pain. All diagnosed as ankylosing spondylitis.  Treatment is Lortab, Meloxicam and muscle relaxers.
Age: 23.0
Sex: M
Vaccine: HEPA, SMALL, TDAP, HEPA, SMALL, TDAP
Symptoms: Ankylosing spondylitis, Arthralgia, Back pain, Cytogenetic analysis normal, HLA marker study
Clinical narrative: Severe low back pain, intermittent paralysis, severe joint pain. All diagnosed as ankylosing spondylitis.  Treatment is Lortab, Meloxicam and muscle relaxers.
Age: 23.0
Sex: M
Vaccine: HEPA, SMALL, TDAP, HEPA, SMALL, TDAP
Symptoms: Laboratory test normal, Paralysis
Clinical narrative: Severe low back pain, intermittent paralysis, severe joint pain. All diagnosed as ankylosing spondylitis.  Treatment is Lortab, Meloxicam and muscle relaxers.
Age: 13.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Haematochezia
Clinical narrative: Shaking, shivering, at start, developed into twitching, muscle tremors, aches, pains weakness, head drops rolls, hallucinations, insomnia, muscle lock ups, exhaustion, severe sleep apnea, headaches, diarrhea, bloody stool on a regular basis, head drops, rolls, uncontrollable spasms.
Age: 13.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hallucination, Headache, Immediate post-injection reaction, Insomnia, Muscle spasms
Clinical narrative: Shaking, shivering, at start, developed into twitching, muscle tremors, aches, pains weakness, head drops rolls, hallucinations, insomnia, muscle lock ups, exhaustion, severe sleep apnea, headaches, diarrhea, bloody stool on a regular basis, head drops, rolls, uncontrollable spasms.
Age: 13.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Muscle twitching, Pain, Posture abnormal, Shock, Sleep apnoea syndrome
Clinical narrative: Shaking, shivering, at start, developed into twitching, muscle tremors, aches, pains weakness, head drops rolls, hallucinations, insomnia, muscle lock ups, exhaustion, severe sleep apnea, headaches, diarrhea, bloody stool on a regular basis, head drops, rolls, uncontrollable spasms.
Age: 13.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Tremor
Clinical narrative: Shaking, shivering, at start, developed into twitching, muscle tremors, aches, pains weakness, head drops rolls, hallucinations, insomnia, muscle lock ups, exhaustion, severe sleep apnea, headaches, diarrhea, bloody stool on a regular basis, head drops, rolls, uncontrollable spasms.
Age: 12.0
Sex: F
Vaccine: FLUN4, HEPA
Symptoms: Dyskinesia, Eye movement disorder, Pallor
Clinical narrative: Pt started with reaction as needle for Hep A immunization was removed from her arm. Her eyes rolled back in her head, she got very pale, and her arms were making jerking movements. This lasted about 90 seconds.
Age: 0.67
Sex: M
Vaccine: HEP
Symptoms: Dehydration, Diarrhoea, Nausea, Pyrexia, Rash
Clinical narrative: Fever. Diarrhea. Rash. Dyhydration. Nausea.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Measles antibody positive, Parvovirus B19 test negative, Pyrexia, Rash generalised, Rubella
Clinical narrative: Had 100.2 fever, then the next day woke up with rash all over body that began around the neck and face and slowly spread through out.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Crying, Pyrexia
Clinical narrative: Fever and inconsolable crying for 2 days following immunization.
Age: 1.01
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Pyrexia, Rash generalised, Rash morbilliform
Clinical narrative: 102.5 fever which persisted for 2.5 days at which a measles-like rash then started and spread to entire body on 8/12/2013.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Blood immunoglobulin G, Blood immunoglobulin M, Rash, Scab
Clinical narrative: 8/1/2013: Broke out with vesicles, no viral s/s. 8/4/2013: Went to ER told vaccine induced rash. 8/5/2013: Went to Employee Health at other job IgG & IgM drawn. Still with vesicles. 8/7/2013: Went to Employee Health. Still with some open vesicles. Sent home. 8/9/2013:  No  open vesicles, all leisions crusted, no other s/s. Cleared to work.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Cellulitis 6x7 area of erythema on the left outer arm--tender with edema.  Area is hot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation
Clinical narrative: Injection site became very red and inflamed and continued to spread to entire thigh.  Seen in ED 8-10-13 and diagnosed with cellulitis and started on Keflex 250 mg bid.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Dizziness, Fainting, Nausea.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash and itchiness at injection site.
Age: 1.04
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Induration, Injection site swelling, Urticaria
Clinical narrative: Bilateral thigh swelling/induration and raised hive-like lesions.
Age: 49.0
Sex: F
Vaccine: PER
Symptoms: Injection site discolouration, Joint range of motion decreased, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Unable to raise left arm, continuous ache on left arm, limited range of motion, pain when moving arm backwards. Discoloration around injection site. Naproxen and Tylenol 3 with codeine eases pain a little.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Irritability, Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Child had a low grade temperature and increased fussiness.  3 days later a red plotchy rash appeared on tummy.  Rash lasted a day and was almost clear.  7 days after first fever appeared child came down with a fever of 101. Fever lasted one day.  Rash reappeared 2 days after 2nd fever and now spread to face and was brighter pink.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Dyskinesia, Tic
Clinical narrative: Head tic. Child would jerk head quickly in an upward motion, repeatedly. Worsened with increased activity. Was unaware of it. Sought medical advice, but was dismissed.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal faeces, Bacterial test negative, Culture stool negative, Diarrhoea, Faeces discoloured
Clinical narrative: Pt developed loose, green, mucousy and eventually mildly bloody stools 1 day following rotavirus vaccination. Pt also received other 2 mo vaccines at the time.  Loose stools persisted for approximately 6 weeks.  No associated abdominal pain as perceived by parents. Abnormal stools have now resolved, but pt was not vaccinated with rotavirus again.  Tolerated all other 4 mo vaccines well.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Mucous stools, Occult blood positive, Stool analysis abnormal
Clinical narrative: Pt developed loose, green, mucousy and eventually mildly bloody stools 1 day following rotavirus vaccination. Pt also received other 2 mo vaccines at the time.  Loose stools persisted for approximately 6 weeks.  No associated abdominal pain as perceived by parents. Abnormal stools have now resolved, but pt was not vaccinated with rotavirus again.  Tolerated all other 4 mo vaccines well.
Age: 11.0
Sex: F
Vaccine: PPV
Symptoms: Extensive swelling of vaccinated limb, Pyrexia
Clinical narrative: Fever 101-102 whole limb swelling left upper arm.
Age: 1.17
Sex: U
Vaccine: HEPA, MMR
Symptoms: Body temperature increased, Rash, Rash generalised
Clinical narrative: Received MMR 7-12-13 7-21-13 mild rash, temp 99.5 ax 7-22-13 rash whole body and in mouth, temp 101.5 ax 7-23-13 saw dr at clinic.
Age: 33.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Radial nerve palsy
Clinical narrative: Pt c/o numbness in arm. States unable to use (R) arm. Went to ER 8/9/13. States was dx with Wrist Drop Splint applied per MD. Has movement in fingers.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site induration, Pain in extremity
Clinical narrative: Red area about 2 1/2 inch diam lasted at least 3 days. Took BENADRYL and used calamine. Arm hurt. Also hard area at inj site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Local redness and itching noted after KINRIX and varicella vaccine. First noted by parent 8/5/13 vaccine given 8/2/13. Reaction 3 in x 3 in (L) arm.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Sluggishness
Clinical narrative: 7/25/13 700 am 1 in diameter around injection site, redness, swelling, pain and warmth. 7/26/13 am 2" diameter around site red, swollen, warm, increased pain iced 6 x 20 min that day. No fever 7/27/13 am area increased to 2" (ht) x 23" (width), More painful, increased redness, swollen and hot to touch, iced 10 x for 20 min each. Sluggish, no fever 7/28/13 Size 2" x 2" was still red, swollen, warm and was painful. No fever. By 7/29/13 am, ara was 1 in by 1 in. Was much less swollen, red, and had very little pain. I iced the area four times that day. No fever. 7/30/13-8/04/13 injection site was sore, sensitive, and achy. No redness or warmth. No fever. 8/05/13 injection site feels normal.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Contusion, Erythema, Pain in extremity
Clinical narrative: Pt reports arm began to hurt more 08/10/13. (R) arm redness started 08/11/13. Came in to office 8/12/13. Area 16.5 x 12 cm reddened, warm. Bruise superiorly.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient has redness on the right arm and pain. The pain started late in the evening on 8/7/13. Pt has no temp. It was warm to touch.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Child received vaccine 8-9-13 at approx 1:30 pm. Approx 4:00 pm left arm swelled to twice the normal size was bright red, hot to touch. Parent took child to ED. Child was given BENADRYL 25 mg po, epinephrine 1 mg IM and a script for prednisone 10 mg 1 daily for 5 days. Child had no fever.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Chills, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Body aches, back pain, shaky, chills unsure if he had fever. Arm was painful, injection site red, slightly swollen and hot to touch. Pt took ADVIL, he was better by Sunday 8/11/13.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Tremor
Clinical narrative: Body aches, back pain, shaky, chills unsure if he had fever. Arm was painful, injection site red, slightly swollen and hot to touch. Pt took ADVIL, he was better by Sunday 8/11/13.
Age: 20.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Expired drug administered
Clinical narrative: MMR booster given today had expired 8/1/2013.
Age: 20.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: MMR booster given today had expired 8/1/2013.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Emesis from 8/8/13 1830 - 8/9/13 0600, fever 102.9.
Age: 0.41
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Rash generalised
Clinical narrative: Full body rash 2 hrs after vaccine administration.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: 08/10/2013 Moderate Other. Pt's father asked about serious RXN and denied at time of administration once syncope occurred. Pt's father stated that he had a similar RXN to first HPV vaccine. EMS responded to RXN and assisted pt.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Hypersensitivity, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: August 10, 13 mother took pt to ER for red painful right arm. Redness, whelps itching painful and warmth at injection site.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site pruritus, Injection site urticaria, Injection site warmth, Pain in extremity
Clinical narrative: August 10, 13 mother took pt to ER for red painful right arm. Redness, whelps itching painful and warmth at injection site.
Age: 6.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 6 year old twin patient. On 23-AUG-2007, the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, strength and route: not reported). On 12-AUG-2008, the patient was vaccinated with the second dose RECOMBIVAX HB (dose, strength and route: not reported). On 12-SEP-2008 (4 weeks after the second dose), the patient was vaccinated with the third dose of RECOMBIVAX HB (dose, strength and route: not reported). There was not concomitant medication reported. No adverse effects were reported. The Nurse Practitioner stated that the patient was administered RECOMBIVAX HB at another physician's office. She had no record as to whether or not the patient experienced any side effect related to the doses given off schedule. This is one of two reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a pediatrician, participating in market research, refers to a male pre-adolescent patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. Pediatrician reported that the patient suffered "dizziness" and "faintness" immediately after receiving first in a series of three injections of GARDASIL vaccine. Patient recovered quickly and suffered no reactions to the subsequent injections in the GARDASIL series. Therapy with GARDASIL was continued. The relationship between "dizziness" and "faintness" and GARDASIL was not reported. No diagnostic tests were performed. Additional information is not expected.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a male consumer of unknown date reporting on himself. The patient's medical history included an unspecified vaccine when younger (date and name unspecified), and then received it a second time later on in his life (date and name unspecified). On an unspecified date the patient was vaccinated with a dose of M-M-R II (dose, route, lot number and expiration date unknown). On an unknown date patient had negative results when tested for measles titers after receiving the M-M-R II. The outcome of negative measles titers was not reported. The relationship between the M-M-R II and the negative measles titers was not reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Vomiting
Clinical narrative: This spontaneous report as received from a female consumer of unknown age reporting on herself. On 04-AUG-2013, "4 days ago", the consumer was vaccinated with the first dose of GARDASIL (route and lot # not reported). The consumer reported that in August 2013, she experienced memory loss and vomiting. The consumer stated that she went to the ER but did not state if she was admitted to the hospital. The patient did not receive treatment for the adverse events. The outcome of memory loss and vomiting was reported as not recovered/not resolved. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 28-JUL-2010 the patient received an expired dose of PNEUMOVAX23 25/0.5 (lot # 662747/1086X, exp date 06-JUN-2010) (route unspecified). Concomitant medications were not reported. No adverse effect reported. This case is linked to case 1307USA013390, 1307USA015840, 1307USA015841, and 1307USA015839 via same reporter link. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 15 year old female patient with no pertinent medical history and with an unknown reaction to penicillin and aspirin. On 06-AUG-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose and route not reported). The medical assistant reported that on 06-AUG-2013 reported as "immediately following", while still in the physician's office, the patient "fell over the side of the bed onto the floor". The medical assistant reported that the physician was able to arouse the patient "shortly after". It was reported that they continued to monitor the patient for the next hour and the patient fully recovered (on 06-AUG-2013). It was reported that the patient sustained no injuries. The medical assistant reported that the vital signs were checked within normal limits. Ice was put on the patient's forehead as treatment. The reporter did not assess the causality between GARDASIL and "fell over the side of the bed onto the floor". Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a currently 73 years old female patient with allergy to CIPRO and penicillin, advanced osteoarthritis, mitral valve prolapse. Grave's disease and hypothyroidism secondary to Grave's disease. In 2012, "sometime last year", the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). Concomitant therapies included SYNTHROID. The physician reported that on an unknown date, she experienced negative titers: IgM 0.90 for varicella antibody. The patient did not receive treatment for the adverse event and did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. It was reported that on an unspecified date, several months ago, the patient received their first dose of GARDASIL (Lot # not reported) (dose and route not reported). Concomitant therapy was not reported. On 08-AUG-2013 the patient went the office and would like to receive the second dose of GARDASIL. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 2 or 3 patients of unknown age (gender not provided). On an unknown date the patients were vaccinated with two doses of GARDASIL (dose, route and lot # not reported) separately. The medical assistant reported that on an unknown date the "2 or 3 patients in the past" had received dose 2 of GARDASIL late. No symptoms reported. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a consumer, for ZOSTAVAX, a Pregnancy Registry product, concerning her friend, an approximately 33 year old female patient. On 01-JUL-2013 the patient was vaccinated with ZOSTAVAX, 1 single standard dose, subcutaneously. Soon after that the patient discovered pregnant. At the time of the report, the patient was 5 weeks and 2 days pregnant. No adverse event was reported. The LMP was approximately on 18-JUN-2013 and EDD is 25-MAR-2014. Additional information is not expected.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, lot #, dose and route unspecified influenza virus vaccine (manufacturer unknown and AFLURIA could not be ruled out), lot#, dose and route unspecified. The patient had no concomitant medication. On an unknown date, the patient experienced a rash and redness at the injection site "and beyond". The patient sought medical attention via phone call to unspecified physician. The outcome of the patient was reported as recovered/resolved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Hypoaesthesia, Joint stiffness, Muscle tightness, Pain in extremity
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 18 year old female patient. The patient had no concomitant medication, no pertinent medical history and drug reaction/allergies. On 28-MAY-2013 the patient was vaccinated with her first dose of GARDASIL (lot # H021346, Exp date 01-OCT-2015) 0.5 ml, intramuscularly, and on 30-JUL-2013 the patient received her second dose of GARDASIL (Lot # unspecified) 0.5 ml, intramuscularly in right arm. In July 2013, the patient experienced hip and leg tightness and pain (both legs) after receiving her second dose of GARDASIL on 30-JUL-2013. The patient was also experiencing numbness of her feet while walking, and a sensation of "restless" legs. Patient sought medical attention by phone call to clinic by patient's mother. No treatment was given for the event and no lab diagnostics studies performed. The outcome of the patient was reported as not recovered/not resolved. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Restless legs syndrome
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 18 year old female patient. The patient had no concomitant medication, no pertinent medical history and drug reaction/allergies. On 28-MAY-2013 the patient was vaccinated with her first dose of GARDASIL (lot # H021346, Exp date 01-OCT-2015) 0.5 ml, intramuscularly, and on 30-JUL-2013 the patient received her second dose of GARDASIL (Lot # unspecified) 0.5 ml, intramuscularly in right arm. In July 2013, the patient experienced hip and leg tightness and pain (both legs) after receiving her second dose of GARDASIL on 30-JUL-2013. The patient was also experiencing numbness of her feet while walking, and a sensation of "restless" legs. Patient sought medical attention by phone call to clinic by patient's mother. No treatment was given for the event and no lab diagnostics studies performed. The outcome of the patient was reported as not recovered/not resolved. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a 54 year old female with no pertinent medical history and no drug reactions or allergies. On 09-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as J001005 and 24-APR-2014 respectively, dose and route unspecified). There was no concomitant therapy. Approximately on 11-JUL-2013, about two days after administration of ZOSTAVAX, the patient experienced redness at the injection site that measured about 3 inches. The patient did not seek any medical attention. She was treated with BENADRYL and cortisone. No lab tests were performed. Approximately on an unknown date in 2013, the patient was recovered from redness at the injection site that measured about 3 inches. The relatedness for redness at the injection site that measured about 3 inches was unknown for ZOSTAVAX. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 20 year old female patient. The pharmacist reported that the patient received first dose of GARDASIL (dose, route and lot # not provided) at 14 years of age (approximately in 2007) and was in pharmacy to receive the second dose of GARDASIL on 30-JUL-2013. No adverse effect. It was unknown if the patient had sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On 26-FEB-2003 the patient was vaccinated with VARIVAX (Merck) dose 1 (subcutaneous; dosage and lot number unknown). On 08-AUG-2013 the patient was vaccinated with VARIVAX (Merck) dose 2 (subcutaneous; dosage unknown, lot # G007461 exp 02-AUG-2013). The healthcare worker reported that the patient received an expired VARIVAX (Merck) dose. No adverse effect was reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Interchange of vaccine products
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old female patient. On 06-AUG-2013, the patient was inadvertently vaccinated with a single dose of GARDASIL (Lot # H021346, expiration date 01-OCT-2015) intramuscularly after the patient had received three doses of CERVARIX. The physician stated that this was an other than indicated use of GARDASIL. It was also reported that the patient had an unspecified reaction after receiving the third dose of CERVARIX. The patient did not have a reaction to GARDASIL. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a pediatrician, participating in market research, refers to a female pre-adolescent patient of unknown age who on an unknown date, was vaccinated with the first dose of GARDASIL (dose, route and lot number were not reported). Concomitant medications were not reported. Pediatrician reported that the patient experienced "dizziness" and "faintness" in the pre-adolescent girl after receiving first in a series of three injections of GARDASIL vaccine. The patient was taken to a nearby emergency room (ER), where she recovered (also reported as recovering) after a few hours and went home. The patient received the rest of the series without incident. The relationship between "dizziness" and "faintness" and GARDASIL was reported as related. No diagnostic tests were performed. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old female patient. On 05-AUG-2013 the patient was vaccinated with the fifth dose of GARDASIL (lot # and expiration date unspecified) injection (dose, route and anatomical location unspecified) for prophylaxis. The physician reported that patient received 5 doses of GARDASIL. The patient received the first dose on 22-NOV-2011, the second dose on 13-JUL-2012, the third dose on 15-JAN-2013, the fourth dose on 23-JUL-2013 and the fifth dose on 05-AUG-2013 (dose, route and anatomical location unspecified for all). No adverse effect reported. The physician reported that the patient was a foster child and then adopted, the patient's initials changed, so he did not realize the patient was in the registry twice, so the patient received 5 doses of GARDASIL all together. The patient's outcome was unknown. Additional information has been requested.
Age: 0.9
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 10 month old female patient. No medical history or drug allergies/reactions were reported. On 29-JUL-2013, the 10 month old patient was vaccinated with the 3 dose of ROTATEQ in the series, (dose and route not provided). No adverse effect reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 years old male patient with no pertinent medical history and drug reactions/allergies. On 15-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# J000783, expiration date: 30-APR-2014), unspecified dose and route at an unspecified location. No concomitant therapies were reported. On 16-JUL-2013 the patient developed a red, itchy area, warm to the touch, about 6 inches below the injection site of the ZOSTAVAX vaccination (no rash reported). The patient had sought medical attention via contacting pharmacy. No lab diagnostics studies were performed. At the time of report, the outcome of the events was not recovered. This is one of several reports received from the same source. Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Dysmenorrhoea, Exposure during pregnancy, Premature labour, Preterm premature rupture of membranes
Clinical narrative: Case number PHHY2013US069546 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 470814) web site on 03 Jul 2013, and with a follow up report received from QA department on 08 Aug 2013. This is also a quality complaint report (239724). This report refers to a 32-years-old pregnant female patient. Her current conditions included environmental allergies such as dust mite and grass pollen, allergy to erythromycin and sulfisoxazole and common cold. Her concomitant medications included metformin and prenatal vitamins. She was vaccinated with FLUVIRIN (batch number: 1204601) on to left arm on 21 Sep 2012. On 26 Sep 2012, she had period cramps. The water broke prematurely on 28 Sep 2012 and contractions started. It was reported that miscarriage happened on 29 Sep 2012. She went to emergency room. The final outcome was reported as complete recovery. Based on the review performed, FLUVIRIN product with batch 1204601 was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow up report received from QA department on 08 Aug 2013. Updated batch review report.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Product quality issue
Clinical narrative: Case number PHHY2013US069546 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 470814) web site on 03 Jul 2013, and with a follow up report received from QA department on 08 Aug 2013. This is also a quality complaint report (239724). This report refers to a 32-years-old pregnant female patient. Her current conditions included environmental allergies such as dust mite and grass pollen, allergy to erythromycin and sulfisoxazole and common cold. Her concomitant medications included metformin and prenatal vitamins. She was vaccinated with FLUVIRIN (batch number: 1204601) on to left arm on 21 Sep 2012. On 26 Sep 2012, she had period cramps. The water broke prematurely on 28 Sep 2012 and contractions started. It was reported that miscarriage happened on 29 Sep 2012. She went to emergency room. The final outcome was reported as complete recovery. Based on the review performed, FLUVIRIN product with batch 1204601 was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow up report received from QA department on 08 Aug 2013. Updated batch review report.
Age: 28.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal disorder
Clinical narrative: Case number PHHY2013US069587 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 474648) website on 03 Jul 2013 with a follow up information received from the quality assurance department (QA reference number: 238916) on 12 Aug 2013. This report refers to a 28-year-old pregnant female patient. The patient had no previous history of miscarriage. She had one living child aged 15 months. Her concomitant medications included prenatal vitamins, over the counter medications (unspecified). It was reported that fetus stopped developing at the time of immunization. She was vaccinated with S-OIV FLUVIRIN (batch number: 102044P1) intramuscularly in the left arm on 12 Nov 2009. On 15 Nov 2009, she had a miscarriage. She was taken to the emergency room. The event outcome was reported as not reported. The causality was not reported. Based on the batch review report (238916) received from quality assurance department on 12 Aug 2013, it was concluded that the S-OIV FOCETRIA batch, 102044P1 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 12 Aug 2013: Batch summary updated.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Blood culture, CSF test normal, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Case number PHHY2013US012247 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 475917) on 08 Feb 2013, and with a follow up report received from QA department on 12 Aug 2013: This is also a quality complaint report (215599). This report refers to an 11-year-old male patient. His medical history included gastroesophageal reflux and hyperlipidemia and his concomitant medications included omeprazole. He was vaccinated with MENVEO (batch number M11052) intramuscularly on 23 Oct 2012. On 24 Oct 2012, the child complained of bilateral leg weakness and the condition worsened progressively. He was admitted to hospital from 10 Nov 2012 to 15 Nov 2012 and received 2 doses of intravenous immunoglobulin G. His symptoms improved following the treatment. Cerebrospinal fluid test was done and it revealed negative results, blood culture was also performed; however results were not reported. He visited the emergency room (ER) following this reaction. Final outcome was reported as condition unchanged as on 20 Nov 2012. No further information about causality and seriousness was provided. Based on the review performed, this product MENVEO batch number M11052 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from QA department on 12 Aug 2013: Updated batch review report.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site reaction, Melanocytic naevus, Tenderness
Clinical narrative: Initial report was received from a healthcare professional on 29 July 2013. A 64-year-old female patient had received an injection in the left arm of FLUZONE Intradermal (lot number UT4470AA) on 11 January 2013 (route of administration not reported) and an unspecified amount of time later experienced sore arm, weakness of arm in that she is dropping things, and tingling and numbness of the left leg which continued at the time of the report. No other information was provided. Outcome was not recovered. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Initial report was received from a healthcare professional on 29 July 2013. A 64-year-old female patient had received an injection in the left arm of FLUZONE Intradermal (lot number UT4470AA) on 11 January 2013 (route of administration not reported) and an unspecified amount of time later experienced sore arm, weakness of arm in that she is dropping things, and tingling and numbness of the left leg which continued at the time of the report. No other information was provided. Outcome was not recovered. Documents held by sender: None.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN, MNQ
Symptoms: Road traffic accident
Clinical narrative: Approximately 5 minutes after receiving MCV4 vaccine, patient had an episode of syncope while driving home, he subsequently hit a tree, resulting in pulmonary contusions, pneumothorax, left tibial and hip fracture, liver and spleen lacerations requiring ICU care.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN, MNQ
Symptoms: Hip fracture, Intensive care, Pneumothorax, Pulmonary contusion, Road traffic accident
Clinical narrative: Approximately 5 minutes after receiving MCV4 vaccine, patient had an episode of syncope while driving home, he subsequently hit a tree, resulting in pulmonary contusions, pneumothorax, left tibial and hip fracture, liver and spleen lacerations requiring ICU care.
Age: 16.0
Sex: M
Vaccine: MNQ, MEN, MNQ
Symptoms: Splenic rupture, Syncope, Tibia fracture, Traumatic liver injury
Clinical narrative: Approximately 5 minutes after receiving MCV4 vaccine, patient had an episode of syncope while driving home, he subsequently hit a tree, resulting in pulmonary contusions, pneumothorax, left tibial and hip fracture, liver and spleen lacerations requiring ICU care.