chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: PER
Symptoms: Grand mal convulsion, Nuclear magnetic resonance imaging brain normal, Partial seizures
Clinical narrative: Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as Dravet syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with Dravet syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related temporally to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09348, -09598, -09599, and -09600. A two-month-old male patient had received a pertussis vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and less than 12 hours after vaccination, he developed a febrile generalized convulsion. After 1 year of age, the patient developed other seizure types including generalized tonic clonic, partial and hemiconvulsions, which were intractable to multiple medication trials. Cognitive development was noted as delayed. The patient also developed behavioral issues with autistic-like features. Brain MRI results were normal. At 20 years of age, patient was diagnosed with Dravet syndrome based on his clinical phenotype and his SCN1A (neuronal sodium channel alpha-1 subunit) testing which showed the deletion of one copy of all 26 exons. Parental SCN1A testing was not possible for this patient because he had been adopted. EEG findings at the time of diagnosis revealed focal discharges and slowing. Outcome was not recovered. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 29 September 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a six month old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3734AB received on 15 March 2011, PENTACEL (lot number not reported) received on 12 May 2011 and lot number C3879AA received on 12 July 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 07 August 2011, approximately 26 days after the last dose. On 14 August 2011, the subject developed a paroxysmal cough with a whoop. The subject did not experience any posttussive vomiting, apnea or sleep disturbance. Laboratory testing included positive PCR on 17 August 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 17 August 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 12 September 2011, the subject's cough was resolved. The duration of the cough was reported at that time as 18 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction
Clinical narrative: Initial report received on 29 September 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a six month old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3734AB received on 15 March 2011, PENTACEL (lot number not reported) received on 12 May 2011 and lot number C3879AA received on 12 July 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 07 August 2011, approximately 26 days after the last dose. On 14 August 2011, the subject developed a paroxysmal cough with a whoop. The subject did not experience any posttussive vomiting, apnea or sleep disturbance. Laboratory testing included positive PCR on 17 August 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 17 August 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 12 September 2011, the subject's cough was resolved. The duration of the cough was reported at that time as 18 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: PER
Symptoms: Adverse event
Clinical narrative: Initial report was received via a company sponsored website on 26 September 2011 from a consumer, who is also the patient's parent. A four-month-old female patient had received a second dose pertussis vaccine (manufacturer, lot number, route, site and date of administration not reported), and an unspecified amount of time later, she experienced horrific side effects (unspecified). According to the reporter, "the pertussis vaccine almost killed my child". The reporter also stated that "they said the dose probably had too much pertussis in it and she wouldn't need that part again". The patient never received a pertussis vaccine again. Outcome was not reported. Documents held by sender: None.
Age: 0.76
Sex: F
Vaccine: HIBV
Symptoms: Listless, Somnolence, Unresponsive to stimuli
Clinical narrative: Initial report was received from another manufacturer on 23 September 2011, with follow-up information received from the patient's parent who is also a health care professional on 26 September 2011; both reporters were in the same country. A nine-month-old female patient had received a second dose intramuscular injection of ACTHIB, lot number UH090AB (corresponding sanofi pasteur SA lot number E0744-2) on 15 November 2010 and approximately 40 minutes later, the patient became listless and unresponsive. When asked if the patient lost consciousness, the patient's parent stated that was difficult to answer and explained that resuscitation was not required, but she could not awaken her daughter with a jaw lift. Breathing and heart rate were fine. The patient recovered on the way to the emergency room and was not evaluated there. According to the patient's parent, the event lasted 20 minutes (also reported as one hour) from the time of onset and then her daughter completely recovered. The event did not require treatment. Laboratory and diagnostic testing was not performed. The patient has since had her Hib titers checked and her titers were adequate so she would not be receiving any further doses of Hib vaccine. The patient had no concurrent illness or pre-existing medical conditions at the time of vaccination. The patient had previously received an intramuscular second dose injection of PCV vaccine (manufacturer Wyeth, lot number 914513) on 18 October 2010. Outcome was recovered. The case was initially reported as non-serious, but was upgraded to serious by the company due to other medically significant event. Documents held by sender: None.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site reaction
Clinical narrative: Localized erythema on L shoulder at injection site 8cm round-non tender, No discharge. No fever.
Age: 73.0
Sex: U
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Headache.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Febrile convulsion
Clinical narrative: Seizure from fever of 101 degrees F.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Presyncope, Rash, Sensation of heaviness
Clinical narrative: Patient had dizziness after the shot. Felt better left the health department. Went to school. Called mom from school went to Dr. office with complaints of dizziness near syncope, rash around mouth, extremities felt heavy.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Loss of consciousness, Nausea, Pallor, Syncope
Clinical narrative: .5cc of Sanofi Pasteur Influenza Virus Vaccine, Lot UH486AD was administered to patient immiediately once vaccination was administered, administrator, noted that patient became pale, as she began to faint, administrator assisted patient to the floor, administrator reports patient was unconscious for approximately 3-5 seconds. Immediately, 4 RN's were at the scene of the incident. A cool pack was placed behind clients neck,  Vitals were obtained blood pressure 98/56, respirations 18, pulse 72, clients color started to return and she was orientated times 3. Dr. came to clients aid and also assessed client vitals and found them to be With-in Normal Limits. Client was then assisted to sitting position on the floor and then to sitting in the chair. Client was given crackers and water. She reported she had not ate since lunch at about 11:30 and then had Volleyball practice immediately after school and then came to get her flu shot. Dr. again reassessed her vitals, he reported they remained with in normal limits and were unchanged from laying, sitting to standing.  Client reported she was feeling "fine". She was assisted by her mother to the waiting area of the post vaccination area, she waited another 15 minutes and denied any concerns at that time and left the facility. 10/12/11 RN, followed up with Mother at 11:34 am mother reported "patient is doing just fine.  We went home right afterward, she did feel like she was going to vomit though!  She slept for a while and then ate.  She's feeling good today.  I want to thank you for all of your help yesterday.  I tend to panic when my kids are hurt.  All of you were so very helpful and I knew that we were in good hands.  Thanks for checking on us too.  Have a great day!" .
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: Started as normal shot site soreness.  By 10/06/11 could barely lift left arm. Treated w/Advil. By day 3 stared applying hot compresses and taking prescription ibuprofen. 7 days later left arm is still sore, radiating to shoulder and neck, numbness in fingers, headache on left side of leftside. Stopped by pharmacy to ask, told to see own Dr. and report to VAERS.  Waiting on personal Dr. to return call as to course of treatment to resolve pain and numbness.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain
Clinical narrative: Started as normal shot site soreness.  By 10/06/11 could barely lift left arm. Treated w/Advil. By day 3 stared applying hot compresses and taking prescription ibuprofen. 7 days later left arm is still sore, radiating to shoulder and neck, numbness in fingers, headache on left side of leftside. Stopped by pharmacy to ask, told to see own Dr. and report to VAERS.  Waiting on personal Dr. to return call as to course of treatment to resolve pain and numbness.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Myalgia, Pyrexia, Throat irritation
Clinical narrative: Fever, Chills, Muscle Aches, Cough and Itchy Throat...all symptoms lasted 9 hours
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dysphonia, Dyspnoea
Clinical narrative: Coughing, trouble breathing, tightness in chest, hoarseness
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid ptosis, Hypoaesthesia oral, Paraesthesia oral, VIIth nerve paralysis
Clinical narrative: Bells Palsy (per patient), Pt complains of L eye droop, numbness and tingling to mouth.
Age: 0.59
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture, Body temperature decreased, Chest X-ray, Culture urine, Dyspnoea
Clinical narrative: Patient was noted by mother to have difficulty breathing and lethargy. Patient was brought to ER and noted to some difficulty breathing and lethargy. A septic wrkup was performed and patient was given IV rocephin pending lab cultures.  Temperature upon admission to ER was 95.3 but repeat temperature before transfer was 98.1.  Patient was transferred to another Hospital for admission for difficulty breathing.  During hospital stay, patient continued to recieve IV ceftriaxone.  Within 24 hours, patient was back to baseline level, tolerating feedings without vomitting.  Patient remained afebrile during hospital stay.  Patient was discharged from hospital 05/15/2011.
Age: 0.59
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Echocardiogram, Electrocardiogram, Full blood count, Laboratory test, Lethargy
Clinical narrative: Patient was noted by mother to have difficulty breathing and lethargy. Patient was brought to ER and noted to some difficulty breathing and lethargy. A septic wrkup was performed and patient was given IV rocephin pending lab cultures.  Temperature upon admission to ER was 95.3 but repeat temperature before transfer was 98.1.  Patient was transferred to another Hospital for admission for difficulty breathing.  During hospital stay, patient continued to recieve IV ceftriaxone.  Within 24 hours, patient was back to baseline level, tolerating feedings without vomitting.  Patient remained afebrile during hospital stay.  Patient was discharged from hospital 05/15/2011.
Age: 0.59
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Metabolic function test, Urine analysis
Clinical narrative: Patient was noted by mother to have difficulty breathing and lethargy. Patient was brought to ER and noted to some difficulty breathing and lethargy. A septic wrkup was performed and patient was given IV rocephin pending lab cultures.  Temperature upon admission to ER was 95.3 but repeat temperature before transfer was 98.1.  Patient was transferred to another Hospital for admission for difficulty breathing.  During hospital stay, patient continued to recieve IV ceftriaxone.  Within 24 hours, patient was back to baseline level, tolerating feedings without vomitting.  Patient remained afebrile during hospital stay.  Patient was discharged from hospital 05/15/2011.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Myoclonus
Clinical narrative: Myoclonic jerking, whole body, progressively getting worse over past 2 1/2 hours.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Chest pain, Cough
Clinical narrative: First symptom at about 9:15 PM was itching in chest. Started coughing, and chest began to tighten.  During the next 30 minutes, chest kept getting tighter and breathing became difficult. Started wheezing, and it felt like I was breathing through a straw.  Coughing continued w/ diaphoresis and rapid heartbeat. Went to the ER around 10:15 PM. Blood tests were normal; chest x-ray was normal; EKG was abnormal, but was later dismissed. Nebulizer treatment was administered (Duo-Neb). Returned home at 2:00 AM and was able to breathe much better.  Lips and mouth were swollen the following day, chest was sore.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Electrocardiogram abnormal, Heart rate increased, Hyperhidrosis, Lip swelling
Clinical narrative: First symptom at about 9:15 PM was itching in chest. Started coughing, and chest began to tighten.  During the next 30 minutes, chest kept getting tighter and breathing became difficult. Started wheezing, and it felt like I was breathing through a straw.  Coughing continued w/ diaphoresis and rapid heartbeat. Went to the ER around 10:15 PM. Blood tests were normal; chest x-ray was normal; EKG was abnormal, but was later dismissed. Nebulizer treatment was administered (Duo-Neb). Returned home at 2:00 AM and was able to breathe much better.  Lips and mouth were swollen the following day, chest was sore.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Oedema mouth, Pruritus, Wheezing
Clinical narrative: First symptom at about 9:15 PM was itching in chest. Started coughing, and chest began to tighten.  During the next 30 minutes, chest kept getting tighter and breathing became difficult. Started wheezing, and it felt like I was breathing through a straw.  Coughing continued w/ diaphoresis and rapid heartbeat. Went to the ER around 10:15 PM. Blood tests were normal; chest x-ray was normal; EKG was abnormal, but was later dismissed. Nebulizer treatment was administered (Duo-Neb). Returned home at 2:00 AM and was able to breathe much better.  Lips and mouth were swollen the following day, chest was sore.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus generalised
Clinical narrative: Generalize pruritis
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Vision blurred
Clinical narrative: dizzy, blurred vision
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, FLU3, VARCEL
Symptoms: Crying, Musculoskeletal stiffness, Tremor
Clinical narrative: Woke up crying, had stiff extremities and shaking extremities for about 5-10 second, would resolve spontaneously, then reoccur approximately 8 times. Eyes did not roll back, no post ictal period. Dad called 922, by the time EMS arrived, episodes resolved. Parents drove her to the ED.
Age: 1.1
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Varicella post vaccine
Clinical narrative: Mother advised child developed varicella rash 10 days post vaccine. Mother unable to relate if child had fever prior. Has generalized rash without infection (per mom). Child not seen.
Sex: U
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Body pain (gone now). Sore arm.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, IPV, VARCEL
Symptoms: Body temperature increased, Diarrhoea, Dizziness, Fatigue, Immediate post-injection reaction
Clinical narrative: 9-28-11 became dizzy & lightheaded after HPV vaccine administered, site of varicella injection swelled immediately after administration, mother states T 101 degrees that evening with diarrhea & fatigue. 9-29-11 T high 102 degrees mom took to ED, cont with fatigue, diarrhea, red at injection site & appears to have pus at varicella injection site.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, IPV, VARCEL
Symptoms: Injection site discharge, Injection site erythema, Injection site swelling
Clinical narrative: 9-28-11 became dizzy & lightheaded after HPV vaccine administered, site of varicella injection swelled immediately after administration, mother states T 101 degrees that evening with diarrhea & fatigue. 9-29-11 T high 102 degrees mom took to ED, cont with fatigue, diarrhea, red at injection site & appears to have pus at varicella injection site.
Age: 1.58
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: C-reactive protein increased, Infection, Injection site cellulitis, Injection site swelling, Pyrexia
Clinical narrative: Swelling and cellulitis left thigh, fever, received DTaP and influenza vaccines in left thigh, went to emergency room 10/9/11, was admitted and treated with IV clindamycin. No organism identified but elevated CRP and considered likely an infection. Pt. being discharged to home from the hospital 10/12/11 with a 10-day course of oral clindamycin.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Chest pain, Dyspnoea, Injection site induration, Injection site mass
Clinical narrative: LT ARM, LT AXILLARY PAIN. HARD KNOT TO LT DELTOID. DIFFICULTY BREATHING AND CHEST PAIN STARTED IN THE EARLY AM OF 10/06/2011 AS OF 10/11/2011 CONT WITH ARE AND AXILLARY PAIN. DENIES DIFFICULTY BREATHING AND CHEST PAIN.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: LT ARM, LT AXILLARY PAIN. HARD KNOT TO LT DELTOID. DIFFICULTY BREATHING AND CHEST PAIN STARTED IN THE EARLY AM OF 10/06/2011 AS OF 10/11/2011 CONT WITH ARE AND AXILLARY PAIN. DENIES DIFFICULTY BREATHING AND CHEST PAIN.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Dementia
Clinical narrative: Case numbers PHEH2011US05381 is an initial spontaneous report received from a pharmacist on 28 Sep 2011: This report refers to an 88-years-old female patient. Previously she was vaccinated with FLULAVAL (other manufacturer) in the left deltoid on 13 Sep 2011. She was vaccinated with FLUVIRIN (batch number: 1102201) in the left deltoid intramuscularly on 27 Sep 2011. She presented with dementia since a non-reported date. It was stated that the patient had not received any vaccines in the past four weeks. The physician instructed to monitor the patient for 24 hours. The causality and event outcome were not reported. No further information was available at the time of this report.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Pruritus, Wheezing
Clinical narrative: Cough, dyspnea, wheezing started within 2 hours. Itching with no hives. Took BENADRYL with partial relief.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt was give DTap before pt needed it. Pt has had 4 dose already.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Mobility decreased, Plasmapheresis
Clinical narrative: 10/6/11 came into ED with extreme weakness unable to get out of bed. Admitted with possible Guillain Barre. Receiving plasmapheresis -> Flu vaccine about 2 week prior.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL, DTAPIPVHIB, MMR, VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother states Rt arm is swollen & red about 4" circle, warm to touch, uncomfortable, no fever.  Will use a cold pack & cloth on arm & see if it gets better; if not may go to ED this afternoon (9/30).  called 10/4; left msg; no return call.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Oral disorder, Pharyngeal oedema, Respiratory arrest, Visual impairment
Clinical narrative: Patient called to report a severe reaction to her influenza vaccine.  She states this is the first time she has ever received the vaccine.  Patient states that within five minutes of receiving the vaccine she began to "see spots." Her symptoms progressed to a heaviness in her chest and swelling of her throat. She states her husband had to wake her several times during the night because she had "stopped breathing." Patient states she has developed a "growth" under her tongue. Patient states she did not go the the ED. She is going to see her PCP this morning.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Myalgia
Clinical narrative: chills, shivering, muscle aches, headache
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Patient states she had flu type symptoms, with a fever of 101 degrees. Better after several days.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Conjunctivitis, Dyspnoea, Erythema, Hypoaesthesia oral
Clinical narrative: Red face, tight chest, conjunctivitis, numbness in mouth, tingling, hives, difficulty breathing.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Urticaria
Clinical narrative: Red face, tight chest, conjunctivitis, numbness in mouth, tingling, hives, difficulty breathing.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness and edema and warmth at injection sight on right deltoid.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Dysphonia, Eye pruritus, Fatigue, Oropharyngeal pain
Clinical narrative: Itchy eyes, sore throat, hoarseness, tiredness lasting eight days (so far).
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis - ABX Doxycycline prescribed
Age: 22.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site rash, Pruritus
Clinical narrative: Was itchy since a few hours after the shot. Noticed a rash one day after around the area of the shot.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dyspnoea, Eyelid margin crusting, Fatigue, Feeling hot
Clinical narrative: Sore throat, difficulty breathing, increase heart rate, severe fatigue, horrible achiness mostly in extremities, prickly sensation into legs causing legs/feet to feel very hot, difficulty walking related to weakness. Course of symptoms lasted all night by 9:30 am after sleeping the symptoms were gone. Also upon awakening my eyelids were stuck together with yellow matter. No treatment was necessary.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Gait disturbance, Heart rate increased, Oropharyngeal pain, Pain in extremity, Paraesthesia
Clinical narrative: Sore throat, difficulty breathing, increase heart rate, severe fatigue, horrible achiness mostly in extremities, prickly sensation into legs causing legs/feet to feel very hot, difficulty walking related to weakness. Course of symptoms lasted all night by 9:30 am after sleeping the symptoms were gone. Also upon awakening my eyelids were stuck together with yellow matter. No treatment was necessary.
Age: 0.83
Sex: M
Vaccine: FLU3
Symptoms: Irritability, Laboratory test, Pyrexia, Urticaria
Clinical narrative: The evening the immunization was received baby was irritable and parents felt he was running a fever.  The following day, late afternoon, mom noted hives in the armpits, navel, and around the hairline. Mom and grandma brought baby to the ER where they say, "lab work was done". No treatment was given, baby is now well.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Red, Hot and Swelling from shoulder to Elbow - extended beyond elbow by afternoon and child complained of itching by evening.
Age: 26.0
Sex: M
Vaccine: DTAP, HPV4
Symptoms: Back pain, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fever of 99.5. Fatigue. Soreness/Achiness in limbs and lower back.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: LYMPH NODE IN ARMPIT BECAME PAINFUL AND SEVERELY SWOLLEN. WITHIN A FEW HOURS IT WAS THE SIZE OF A GRAPEFRUIT. OTHER NODES IN SURROUNDING AREA ALSO ENLARGED AND VERY TENDER. FEVER.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The patient developed a 1.5cm circular area of erythema and warmth at the injection site.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Erythema, Feeling hot, Hypoaesthesia, Inflammation
Clinical narrative: REDNESS SOFTBALL BALL SIZE INFLAMMATION, WARMTH, NUMBNESS
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: I have experienced mild to moderate itching from 10/08/11 to the present.  I have also experienced mild hives.  The areas affected are my arms and shins.
Age: 30.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis - taken to ER. Given epinephrine shot and Benadryl shot.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: Body ache, headache, pain at the joint, fever, Body temp 104. Severe shivering. pain all over body. Tiredness, vomiting. Swollen at the shoulder about 6".
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Swelling, Vomiting
Clinical narrative: Body ache, headache, pain at the joint, fever, Body temp 104. Severe shivering. pain all over body. Tiredness, vomiting. Swollen at the shoulder about 6".
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia, Pain in extremity
Clinical narrative: Patient states that left arm muscle pain started moderate pain 3 days after deltoid injection in left arm, over 4 wks pain progressed to moderate to mild level occasionally radiating to hand. Taking TYLENOL for it 2-3 times a week.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of numbness of hand and arm in a 27-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergy to amoxicillin and asthma. Concurrent medications included ADVAIR, SINGULAIR, PRO-AIR, Omeprazole and CLARITIN. On 10 October 2011 at 12:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm). On 10 October 2011, 45 minutes after vaccination with FLULAVAL, the subject experienced numbness of right hand and right arm, tingling in the right arm and right hand, dysphagia and nausea. The healthcare professional considered the events were disabling. At the time of reporting the numbness of right hand and right arm was unresolved and the outcome of the other events was unspecified. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pruritus, Ocular hyperaemia
Clinical narrative: Pt complained of red, itchy eyes, wanted a eye drop. Recommended ZADITOR eye drops. Patient stated drops worked and everything cleared up.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Pruritus generalised, Swelling face, Throat irritation
Clinical narrative: Severe headache 10/6/11, all over body itching 10/7/11 am, throat itching 10/7/11 am, facial swelling 10/7/11 pm.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Patient received a flu shot. About 3 minutes after receiving the shot she passed out in front of the pharmacy.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Grand mal convulsion, Vaccine positive rechallenge
Clinical narrative: Patient ended up having two grand mal seizures day after vaccination and ended up in emergency room. Patient's wife stated this has occurred the last 2 years now after flu vaccine, so may be a coincidence.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Injected limb mobility decreased, Injection site erythema, Malaise, Nausea
Clinical narrative: 10-5-11 received flu vaccine Lt deltoid & Rt pneumonia vaccine. 10-6-11 came by clinic Rt upper arm, area red & pt states cannot raise her arm. Feels sick, dizzy & stopped up. Dr informed, instructed to apply ice & take IBU, can call back tomorrow. AM 10/7/11 called & checked on pt. Arm better, still stopped up. Dizziness no better. Nausea. Asked pt if she needed to be seen, felt like she would be OK. 10/7/11 (pm) husband called requested something for nausea. PHENERGAN called in & to take TYLENOL q 4-6 hours.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Respiratory tract congestion
Clinical narrative: 10-5-11 received flu vaccine Lt deltoid & Rt pneumonia vaccine. 10-6-11 came by clinic Rt upper arm, area red & pt states cannot raise her arm. Feels sick, dizzy & stopped up. Dr informed, instructed to apply ice & take IBU, can call back tomorrow. AM 10/7/11 called & checked on pt. Arm better, still stopped up. Dizziness no better. Nausea. Asked pt if she needed to be seen, felt like she would be OK. 10/7/11 (pm) husband called requested something for nausea. PHENERGAN called in & to take TYLENOL q 4-6 hours.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Injection site mass
Clinical narrative: Knot on arm size of 1/2 a grapefruit (at injection site), swollen right eyelid.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Skin warm, Swelling
Clinical narrative: Warm, swelling, redness, raised rash, headache.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient has pain in the arm the vaccine was administered. Patient has been in pain since the vaccine was administered.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Soreness, warmth, swelling, erythema.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 2 days after vaccine administration patient presented to pharmacy with a round, raised, red area (about 4-5 inches in diameter) around area of administer. Reported to be itchy. Patient taking diphenhydramine.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site nodule, Lymphadenopathy
Clinical narrative: Inguinal and cervical lymphadenopathy and nodular reaction at injection site located at thigh.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site inflammation, Injection site pain, Laboratory test normal
Clinical narrative: 10/8/2011 PM. Patient complains of pain in arm and neck originating at injection site. A headache was also reported. The area of injection looked red and inflamed. Patient went to ER. Test results were negative. Patient's symptoms have improved since then with pain medication.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: 10/8/2011 PM. Patient complains of pain in arm and neck originating at injection site. A headache was also reported. The area of injection looked red and inflamed. Patient went to ER. Test results were negative. Patient's symptoms have improved since then with pain medication.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Swelling
Clinical narrative: After 2 weeks post-vaccination, pt experienced arthralgia & numbness presenting in ankle/hands/back of leg. This pain/numbness woke her up during the night. Patient describes swelling & pain which felt like carpal tunnel in 3 fingers.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye swelling, Pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Swollen eyes, fever, swollen throat, aches, difficulty breathing, Txt: prednisone & BENADRYL.
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Headache
Clinical narrative: After about 1 hr after vaccination dizziness and headache started and going on x1 week.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Oedema peripheral
Clinical narrative: Pt. came in due to swelling to right arm.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse drug reaction, Pruritus, Rash, Rash follicular
Clinical narrative: Received flu vaccination in left deltoid intramuscular 09/30/11 about 0545 am. Next morning 10/01/11 noted reddened follicular rash on arms/legs and face. Itching started on 10/03/11. Contacted employee health about symptoms 10/11/11 about 0830 am. Reviewed current meds. with employee and covering employee health physician. Dr. felt symptoms related to ace inhibitor request employee contact primary care physician who stopped lisinopril.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Flu vaccination given 10/10/11 about 17:00 p.m. in right lower deltoid intramuscular; noted 10/11/11 evening 20:00 p.m. redness and heat at injection site. Reported to employee health 10/12/11 about 10:55 AM. Area described above; given anti-inflammatory will apply warm moist heat and follow-up with employee health 10/13/11.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Extrasystoles, Stress echocardiogram normal, Ventricular extrasystoles
Clinical narrative: PVC's with trigeminy-not resolving.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Arrhythmia, Electrocardiogram, Electrocardiogram ambulatory, Stress echocardiogram normal, Ventricular extrasystoles
Clinical narrative: Onset approx. 7 days; after vaccination: cardiac arrhythmia: PVC's with bigeminy and trigeminy - not resolving after 8 months.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Heart rate increased, Oedema peripheral
Clinical narrative: Pt received FLUZONE HD on Mon 10/10/11 -> about 5 hours later patient experienced rapid heart rate and dizziness. On Tuesday, pt's arm was red and swollen. By Wed most swelling was dissipated.
Age: 65.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Pain
Clinical narrative: Patient received 2 vaccinations FLUVIRIN and PNEUMOVAX 23. The PNEUMOVAX 23 stung on injection. Patient complained of temperature & aches later that day & next.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Patient experienced extreme vertigo and required a visit to the Emergency Room.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: Had flu vaccine 10-4-11. On 10-5-11 pt called had experienced some sweating, chills and nausea. On 10-4-11 Nausea. Also heavy/labored breathing yesterday.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Flu injection on 10/3/11 Lt deltoid and PNEUMOVAX on Rt deltoid. 10/4/11 returned to clinic c/o rash around the injection. Redness & warmth anterior left deltoid new site of flu injection (8 x 4). Dx with cellulitis. Started Cefdinir 10/6/11 Area increasing pt came in for injection of ROCEPHIN 10/6/11.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 10/5/11 Arm swollen at flu injection site/Rt arm, swollen at injection site & redness below area Flu vaccine given 10/4/11.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Blister
Clinical narrative: Patient had flu vaccine on 10-7-11. Came by office on 10-12-11 to show me a blister that had developed on his arm about 2 inches from his injection site. Physician felt blister was bandaid related.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient called to tell us she woke up with hives the day after receiving the HD flu shot. Rash on arms & stomach. Itching. Suggested BENADRYL for itching. This is 1st time having HD vaccine.
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of arm pain in a female subject of unspecified age who was vaccinated with Boostrix (GlaxoSmithKline). On 4 May 2011 the subject received 1st dose of Boostrix at 0.5 ml in an unknown arm. On 4 May 2011, less than one day after vaccination with Boostrix, the subject experienced extreme arm pain and insomnia due to arm pain. At the time of reporting the events were unresolved.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of sore arm in a 54-year-old female subject who was vaccinated with Boostrix (GlaxoSmithKline). On an unspecified date the subject received 1st dose of Boostrix, the subject experienced sore arm. At the time of reporting the outcome of the event was unspecified.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Flushing, Hyperhidrosis, Loss of consciousness, Muscle spasms
Clinical narrative: Patient passed out after administration of vaccine (5 seconds later). Patient came to, then reported severe back spasms (lower back); she felt sweaty, flushed, warm. Pt given water to drink & ice for her back. Pt remained at site for 20 minutes she was feeling better & back no longer hurting. Pharmacy intern accompanied pt on errand & back to work.
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of bump at injection site in a female subject of unspecified age who was vaccinated with Boostrix (GlaxoSmithKline). On an unspecified date the subject received a dose of Boostrix (unknown). At an unspecified time after vaccination with Boostrix, the subject experienced bump at injection site. The bump was reported to be sore (injection site soreness). At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Oedema peripheral
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling arm in a subject of unspecified age and gender who was vaccinated with Boostrix (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of Boostrix, subcutaneously. This was an inappropriate route of vaccination. In 2010, at an unspecified time after vaccination with Boostrix, the subject experienced swelling arm. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: DTAP, MNQ
Symptoms: Abdominal pain upper, Dyspepsia, Immediate post-injection reaction
Clinical narrative: This case was reported by a healthcare professional, via another manufacturer, and described the occurrence of stomach pain in a child subject of unspecified gender who was vaccinated with Dtap (with small D + P), manufacturer unspecified, Menactra. On an unspecified date, the subject received unspecified dose of Dtap (with small D + P) (unknown, unknown arm) and unspecified dose of Menactra (unknown, unknown arm). Two seconds after vaccination with Dtap (with small D + P) and Menactra in the same arm, the subject experienced sharp, burning stomach pain. According to the reporter, four other child subject's experienced the same event (sharp, burning stomach pain) two seconds after administration of Dtap (with small D + P) and Menactra in the same arm (see case id's A0887425A, A0887434A, A0887435A, and A0887436A for the other child subjects reports). After the 5th patient complained, the vaccinations were administered in separate arms and there were no further adverse reactions. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: DTAP, MNQ
Symptoms: Abdominal pain upper, Dyspepsia, Immediate post-injection reaction
Clinical narrative: This case was reported by a healthcare professional, via another manufacturer, and described the occurrence of stomach pain in a child subject of unspecified gender who was vaccinated with Dtap (with small D + P), manufacturer unspecified, Menactra. On an unspecified date, the subject received unspecified dose of Dtap (with small D + P) (unknown, unknown arm) and unspecified dose of Menactra (unknown, unknown arm). Two seconds after vaccination with Dtap (with small D + P) and Menactra in the same arm, the subject experienced sharp, burning stomach pain. According to the reporter, four other child subject's experienced the same event (sharp, burning stomach pain) two seconds after administration of Dtap (with small D + P) and Menactra in the same arm (see case id's A0887425A, A0887433A, A0887434A, and A0887436A for the other child subjects reports). After the 5th patient complained, the vaccinations were administered in separate arms and there were no further adverse reactions. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: DTAP, MNQ
Symptoms: Abdominal pain upper, Dyspepsia, Immediate post-injection reaction
Clinical narrative: This case was reported by a healthcare professional, via another manufacturer, and described the occurrence of stomach pain in a child subject of unspecified gender who was vaccinated with DTPa (with small D + P), manufacturer unspecified, Menactra. On an unspecified date, the subject received unspecified dose of DTPa (with small D + P) (unknown, unknown arm) and unspecified dose of Menactra (unknown, unknown arm). Two seconds after vaccination with DTPa (with small D + P) and Menactra in the same arm, the subject experienced sharp, burning stomach pain. According to the reporter, four other child subject's experienced the same event (sharp, burning stomach pain) two seconds after administration of DTPa (with small D + P)and Menactra in the same arm (see case id's A0887425A, A0887433A, A0887435A and A0887436A for the other child subjects reports). After the 5th patient complained, the vaccinations were administered in separate arms and there were no further adverse reactions. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site warmth in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose of BOOSTRIX (unknown, right arm). At an unspecified time after vaccination with BOOSTRIX, the subject experienced injection site warmth, injection site redness and injection site reaction. At the time of reporting the injection site warmth, injection site redness and injection site reaction were resolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. A total of four subjects were report to have had an injection site reaction for the other three cases see A0911826A - A0911828A.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site warmth in a subject of unspecified age and gender who was vaccinated with Boostrix (GlaxoSmithKline). On an unspecified date the subject received 1st dose of Boostrix (unknown, right arm). At an unspecified time after vaccination with Boostrix, the subject experienced injection site warmth, injection site redness and injection site reaction. At the time of reporting the injection site warmth, injection site redness and injection site reaction were resolved. The healthcare professional considered the events were probably related to vaccination with Boostrix. A total of four subjects were reported to have had an injection site reaction for the other three cases see A0911825A, A0911827A and A0911828A
Sex: U
Vaccine: DTAP
Symptoms: Abdominal pain upper, Dyspepsia, Immediate post-injection reaction
Clinical narrative: This case was reported by a healthcare professional, via another manufacturer and described the occurrence of stomach pain in a child subject of unspecified gender who was vaccinated with DTPa (with small D + P), manufacturer unspecified, Menactra. On an unspecified date, the subject received unspecified dose of DTPa (with small D + P) (unknown, unknown arm) and unspecified dose of Menactra (unknown, unknown arm). Two seconds after vaccination with DTPa (with small D + P) and Menactra in the same arm, the subject experienced sharp, burning stomach pain. According to the reporter, four other child subject's experienced the same event (sharp, burning stomach pain) two seconds after administration of DTPa (with small D + P) and Menactra in the same arm (see case id's A0887433A, A0887434A, A0887435A, and A0887436A for the other child subjects reports). After the 5th patient complained, the vaccinations were administered in separate arms and there were no further adverse reactions. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: DTAP, MNQ
Symptoms: Abdominal pain upper, Pain
Clinical narrative: This case was reported by a healthcare professional, via another manufacturer, and described the occurrence of stomach pain in a child subject of unspecified gender who was vaccinated with Tdap (manufacturer unspecified), (non-gsk) MENACTRA. On an unspecified date, the subject received unspecified dose of Tdap (unknown, unknown arm) and unspecified dose of MENACTRA (unknown, unknown arm). Two seconds after vaccination with Tdap and MENACTRA in the same arm, the subject experienced sharp, burning stomach pain. According to the reporter, four other child subject's experienced the same event (sharp, burning stomach pain) two seconds after administration of Tdap and MENACTRA in the same arm (see case id's A0887425A, A0887433A, A0887434A, and A0887435A for the other child subjects reports). After the 5th patient complained, the vaccinations were administered in separate arms and there were no further adverse reactions. At the time of reporting the outcome of the event was unspecified.