chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.66
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "brought home H1N1 mist and gave to 19-month-old" was received from a registered nurse, concerning her 19-month-old son, subsequent to H1N1, Intranasal. The patient's medical history included constipation. The concomitant medication was lactulose 5 cc per oral, once a day, for the treatment of constipation. Since beginning this medication, no further bouts of constipation had occurred for this patient. The reporter brought home the H1N1 from the physician's office where she works and administered the vaccine to her 19-month-old son on 13-Oct-2009. No sniffle, fever, wheezing or other symptoms were noted. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 09-Nov-2009 and incorporated into the narrative: event term was changed from "H1N1 mist brought home and given to her six-month-old" to "brought home H1N1 mist and gave to 19-month-old" and statement regarding medical history and concomitant medication was included.
Age: 0.5
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of "brought home H1N1 vaccine and gave it to six-month-old (sic) niece" was received from a registered nurse concerning a six-month-old female. On 13-Oct-2009, the patient received H1N1, Intranasal. The patient had no medical history and no concomitant medication taken by the patient. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 09-Nov-2009 and incorporated into the narrative: event term was changed from "brought home H1N1 vaccine and gave it to 20-month-old nephew" to "brought home H1N1 vaccine and gave it to six-month-old niece" and statement regarding medical history and concomitant medication was included.
Age: 35.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Drug exposure during pregnancy
Clinical narrative: A non-serious spontaneous report of a "13 week pregnant wife received vaccine" was received from a health professional concerning a 35-year-old female. Medical history has not been reported for this patient. Obstetrical history included gravida two and para two and both deliveries were C-section. Expected date of delivery was 20-Apr-2010. The patient had no problems related to pregnancy and had no illness at the time of vaccination. The patient was 13 weeks pregnant at the time of vaccination. Concomitant medications were prenatal vitamins daily one tablet oral and occasional acetaminophen. Patient received no other vaccination around the time of H1N1 vaccination. On 14-Oct-2009, the patient received H1N1, Intranasal nasally for an unknown indication. On 14-Apr-2010, the patient delivered a healthy baby boy with gestation age of 39 weeks and had no problems during delivery. There was no adverse event associated with this pregnancy. Therefore, treatment and reporter causality assessments are not applicable and the outcome of vaccine exposure during pregnancy was resolved. Additional information was received on 28-Apr-2010 and incorporated into the narrative: pregnancy outcome, neonatal information and concomitant medication. Other information received was responsible physician's details, county where vaccinated. Additional information was received on 10-May-2010 and incorporated into the narrative: Obstetrical history, gestational age of baby, EDD and concomitant medication. Other information received was Reporter's information.
Age: 36.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Headache, Nausea, Vertigo
Clinical narrative: A non-serious, spontaneous report of vertigo, dizziness, nausea and headache has been received from a Physician concerning herself, a 36-year-old female subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on 10-Oct-2009. On 12-Oct-2009 the patient experienced vertigo, dizziness and nausea lasting 48 hours. The symptoms were reported to be so bad as to require an IV. The patient did not report occurrence of fever, although she also had a headache at time of reporting on 15-Oct-2009. The patient recovered from the events of vertigo, dizziness and nausea on 14-Oct-2009. The outcome of the event of headache was not resolved.
Age: 11.0
Sex: F
Vaccine: HPV2
Symptoms: Dermatitis atopic, Injection site pruritus, Injection site reaction
Clinical narrative: This case was reported by a physician and described the occurrence of atopic dermatitis in a 11-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject's medical history included seasonal allergy. Concurrent medications included ZYRTEC. On 23 July 2010 the subject received 1st dose of CERVARIX (.5 ml, unknown route, right arm). On 25 July 2010, 2 days after vaccination with CERVARIX, the subject experienced atopic dermatitis and itching near injection site. The atopic dermatitis and itching occurred on the area above the deltoid on the same arm as she received the vaccination. At the time of reporting the events were improved. The vaccination course with CERVARIX was discontinued. The physician considered the events were possibly related to vaccination with CERVARIX. Follow-up information was received on 17 August 2010. It was reported that the events began on 25 July 2010 and resolved by 01 August 2010. Medical history of seasonal allergies began on 17 December 2002 and continues. It was reported that CERVARIX was given intramuscularly in the right deltoid. Concurrent ZYRTEC was taken orally at 10 mg daily beginning on 17 December 2002 for allergic rhinitis and allergies.
Sex: F
Vaccine: HPV2
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a healthcare professional, via another manufacturer (Merck), and described the occurrence of adverse reaction to vaccine in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of CERVARIX (details unknown). At an unspecified time after vaccination with CERVARIX, the subject experienced adverse reaction to vaccine. At the time of reporting the outcome of the event was unspecified. No further information was provided.
Age: 13.0
Sex: F
Vaccine: HPV2, MNQ, TDAP
Symptoms: Blood pressure fluctuation, Pallor, Tremor
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of blood pressure abnormal in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included ADD, allergy to BENADRYL and low weight. Previous and/or concurrent vaccination included MENACTRA (non-gsk); Sanofi Pasteur MSD; unknown; unknown given on 16 September 2010; TDAP vaccine (non-gsk); Sanofi Pasteur MSD; unknown; unknown given on 16 September 2010. On 16 September 2010 at 13:00 the subject received 1st dose of CERVARIX (.5 ml, unknown, left arm). On 16 September 2010, within seconds of vaccination with CERVARIX, the subject experienced blood pressure changes upon sitting verses standing, loss of color in skin, lips turned white and shaking. The nurse reported the subject was sent to the hospital emergency room (ER) but was not admitted. Neither the ER staff nor the reporting nurse believed that CERVARIX caused the reaction, but rather it was just a reaction to receiving a vaccination. The nurse believed that the subject's low body weight may also be related to these events. On 16 September 2010, the blood pressure abnormal, skin color change, lip color altered and tremor were resolved.
Age: 39.0
Sex: M
Vaccine: TD, DTP
Symptoms: Acute disseminated encephalomyelitis, Coma, Confusional state, Irritability, Violence-related symptom
Clinical narrative: agitation, not sleeping, he would wander off
Age: 39.0
Sex: M
Vaccine: TD, DTP
Symptoms: Acute disseminated encephalomyelitis, Agitation, Insomnia, Restlessness
Clinical narrative: agitation, not sleeping, he would wander off
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Headache lasting two days.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Injection site swelling, Pruritus, Rash papular
Clinical narrative: Patient presents to deployed medical clinic complainig of swelling at smallpox vaccine site, multiple papular lesions on R forearm and bil lower extremities. No lymphadenopathy, no fever, + pruritis, otherwise asymptomatic. Treated with Naproxen and Benadryl.
Age: 55.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Asthenia, Flushing, Heart rate increased
Clinical narrative: Very rapid heartbeat - 99 BPM/high blood pressure, flushing, weakness.  Rapid heartbeat has slowed somewhat but is still rapid compared to what is normal for patient who is very athletic.
Age: 61.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: At the site of the pneumonia shot, the reaction began with itching, tenderness.  When I looked at the site, it was whelped, red, sore and the size of a large egg (ovoid). I called my doctor on Sunday 11/7.  He suggested Benadryl and ice. The site was painful for the first three days. It remained the same shape, but over the next five days it grew to about 3" wide to almost 6" long.  It was the length of the distance between my thumb and forefinger.  On Nov. 11, I found that the tenderness, redness, swelling was lessening from the center outward.  Today is 11/14/2010 and the only remaining symptom is itching.
Age: 87.0
Sex: M
Vaccine: FLUX
Symptoms: Anxiety, Asthenia, Constipation, Decreased appetite, Fall
Clinical narrative: Became very anxious wanting to pace all the time, loss of appetite, constipation and a rash on back, arms, and legs. Doctors don't know what is wrong or what to do. Was given Benadryl, and a cream for the itch and an antianxiety medicine. Nothing is working. Now my dad is weak and falling.
Age: 87.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Rash
Clinical narrative: Became very anxious wanting to pace all the time, loss of appetite, constipation and a rash on back, arms, and legs. Doctors don't know what is wrong or what to do. Was given Benadryl, and a cream for the itch and an antianxiety medicine. Nothing is working. Now my dad is weak and falling.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Nausea, Pyrexia
Clinical narrative: Chills, joint ache, nausea, and fever.  Temperature was at 101°F before taking 975 mg Tylenol at 10 PM. Fever peaked at 101.7°F at 11 PM then was kept at 101°F until it broke at 4 AM.  Additional Tylenol at 4 AM and 400 mg ibuprofen at 9 AM. Feeling of weakness persisted until morning of 11/14.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Erythema, Pain, Swelling
Clinical narrative: Swelling, redness, sharp pain.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Audiogram, Deafness unilateral, Nuclear magnetic resonance imaging brain, Tinnitus
Clinical narrative: 2 weeks after receiving the Zostavax vaccine I developed tinnitus and experiencing some loss of hearing in my right ear. Presently been treated with Prednisone and the Dr. Other brain MRI.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Nausea, Pain, Pyrexia
Clinical narrative: High fever (103) and chills, body aches, nausea, general weakness
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth left upper arm
Age: 1.01
Sex: M
Vaccine: HBHEPB, HEPA, PNC, VARCEL
Symptoms: Abnormal behaviour, Malaise
Clinical narrative: The best way to sum up the symptoms was that he was "zombified".  Before his one-year shots he was a happy, interactive, curious child.  Everything a parent hopes for but then dreads once it happens.  For a month after his one-year immunizations he was in a constant state of apparent malaise.  He didn't play as much or as enthusiastically, he interacted less, he stopped investigating his surroundings almost entirely.  There were no physical symptoms such as fever, rash, weird smells, noticeable change in eating habits, nothing.  The only distinct and sudden change was behavioral.  After about a month he returned to his normal self.  We are recently discovering that there may be a genetic tendency towards kidney problems in his father's side of the family.  It is possible that too many shots at once overloaded his baby kidneys.  I cannot explain why this didn't seem to happen during the previous sets of immunizations when he was younger, I can only speculate that if the symptoms were present perhaps I missed them because he was too young to demonstrate curiosity and interactivity as easily.  He had to redo his one-year series shots about six months later due to the discovery that the immunizations may have been improperly stored.  I insisted they each be done separately with a spacing of a week in between.  He seemed to show a similar but shorter-lived reaction to the Hep B during the repeat injections, Hep B was the last to be administered.
Age: 0.19
Sex: M
Vaccine: HIBV
Symptoms: Hypersomnia, Pyrexia, Screaming
Clinical narrative: Fever, blood curdling screaming that evening.  Excessive sleeping for days afterward.  Fever on & off.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Influenza like illness, Mole excision
Clinical narrative: Patient experienced flu-like symptoms starting 11/12/10. Had an injection of novocaine to have mole removed on 11/12/10. Had skin around right eye swollen on morning of 11/13/10 and corner of left eye had started to swell too.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Uncomfortable right away. Everyday my arm is more sore and now a week and two days later I can barely lift the arm that I received the shot into. The whole upper arm and shoulder is in a lot of pain way deep into the muscle.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site urticaria, Pruritus, Skin burning sensation, Swelling, Urticaria
Clinical narrative: Child Complained of itching and burning skin. Immediately afterwards hives appeared on the back of her neck, face, chest, sides, arms and wrists, back thighs, lower legs and hands. After going to the nearest ER and receiving does of Benadryl, and steroids the Hives subsided. However while taking the ERS prescription for Zyrtec, Hydroxyzine, and Prednisolone Sod. Phos she has continued during the past 26 hours to have 3 repeated flares of Hives, itching and swelling. Currently on hour 26 since being released from ER Care.
Age: 37.0
Sex: F
Vaccine: FLU3, FLUX(H1N1)
Symptoms: Dizziness, Headache, Hypoaesthesia, Hypotension, Muscle spasms
Clinical narrative: CRAMPS, NAUSEA, MUSCLEACHE, HEADACHE, DIZZINESS, LOW BLOOD PRESURE, ONE HOUR. TREATMENT: BENADRYL (IV)
Age: 37.0
Sex: F
Vaccine: FLU3, FLUX(H1N1)
Symptoms: Myalgia, Nausea, Peripheral coldness
Clinical narrative: CRAMPS, NAUSEA, MUSCLEACHE, HEADACHE, DIZZINESS, LOW BLOOD PRESURE, ONE HOUR. TREATMENT: BENADRYL (IV)
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: itching and rash over entire body; lasted about a week (actual time of onset not known; pt said it started 3 to 4 days after receiving flu shot)
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: painless swelling of upper arm at the injection site
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: rash, seen by private MD and was given RX for Prednisone 40mg daily for 3 days
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Oropharyngeal pain, Pyrexia
Clinical narrative: Severe sore throat, then fever and flu symptoms x3 days
Age: 30.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Paraesthesia
Clinical narrative: A non-serious spontaneous report of lightheaded and dizzy and tingling down neck has been received from a healthcare professional concerning herself, a 30-year-old female, subsequent to H1N1 vaccine, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1 vaccine, Intranasal on 16-Oct-2009. The patient received a single dose before onset of the events. On 16-Oct-2009, the patient experienced lightheaded, dizzy, and tingling down her neck. The patient had recovered from the events of lightheaded, dizzy, and tingling down  neck at the time of reporting.
Age: 43.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Corrective lens user, Drug administration error, No adverse event
Clinical narrative: A non-serious, spontaneous report of "some H1N1 mist went into adult's eye" was received from a registered nurse concerning a 43-year-male patient. The patient was a contact lens wearer. Concomitant medications were not reported. The patient received H1N1 2009 MONOVALENT Vaccine on 21-Oct-2009. The nurse reported that while administrating H1N1 mist, some of the H1N1 mist got into the adult's eyes. The patient was wearing contact lens at the time of administration. There was no adverse event associated with this drug administration error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Age: 29.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Caesarean section, Drug exposure during pregnancy, No adverse event
Clinical narrative: A non-serious spontaneous report of 35 weeks pregnant woman got H1N1 was received from a medical assistant/healthcare professional concerning a 29-year-old female patient. The patient did not have any relevant medical history and concomitant medications. The patient's obstetrical history states that she was gravida two, para one. On 21-Oct-2009, the patient received H1N1 2009 Monovalent Vaccine. On 12-Nov-2009, the patient gave birth to a healthy baby boy via cesarean section and the neonate's weight was 8 pounds and 3 ounces, and he had already received a well baby check and remained healthy and doing well. The patient was also fine and in good health. There was no adverse event associated with this pregnancy. The outcome of the vaccine exposure during pregnancy was resolved. Additional information was received on 09-Nove-2009 and incorporated into the narrative: gestation period of 35 weeks, EDD 22-Nov-2009, she was gravida II, para 1. Additional information was received on 07-Dec-2009 and incorporated into the narrative: Birth date of neonate, Gender of neonate, pregnancy outcome, weight of neonate and both are healthy and doing well.
Sex: F
Vaccine: FLUX(H1N1), FLU3, PPV
Symptoms: Headache, Hypokinesia, Local reaction, Malaise, Neck pain
Clinical narrative: Immediate pain on administration then followed by pain in beginning within the first 24 hours which increased in intensity over the next 2-3 days until severe persistent pain became debilitating. Could not lift arm from side more than 3-6 inches. Needed analgesic for pain every 3-4 hours with only partial relief of pain. Patient experienced a sharp pain immediately on injection saying she explained "oh that hurt!". Upon returning home following the administration of the vaccine (s) she recounted her experience stating what she felt and what she said. She also stated that only the injection in the right arm was painful and that she believed the injection was given higher on the arm close to joint between the upper arm and shoulder. Within two hours the pain started and progressively got worse. Over the count analgesics were taken (TYLENOL then ibuprofen). The pain was mitigated but never totally relieved. 10/5/10/6: Consultation with regular physician by phone; recommended rest, continue OTC meds, heat to affected area. 10/12- Seen in the urgent care center. 10/21-Seen by alternative health care provider (chiropractor).
Sex: F
Vaccine: FLUX(H1N1), FLU3, PPV
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Immediate pain on administration then followed by pain in beginning within the first 24 hours which increased in intensity over the next 2-3 days until severe persistent pain became debilitating. Could not lift arm from side more than 3-6 inches. Needed analgesic for pain every 3-4 hours with only partial relief of pain. Patient experienced a sharp pain immediately on injection saying she explained "oh that hurt!". Upon returning home following the administration of the vaccine (s) she recounted her experience stating what she felt and what she said. She also stated that only the injection in the right arm was painful and that she believed the injection was given higher on the arm close to joint between the upper arm and shoulder. Within two hours the pain started and progressively got worse. Over the count analgesics were taken (TYLENOL then ibuprofen). The pain was mitigated but never totally relieved. 10/5/10/6: Consultation with regular physician by phone; recommended rest, continue OTC meds, heat to affected area. 10/12- Seen in the urgent care center. 10/21-Seen by alternative health care provider (chiropractor).
Sex: F
Vaccine: FLUX(H1N1), FLU3, PPV
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Immediate pain on administration then followed by pain in beginning within the first 24 hours which increased in intensity over the next 2-3 days until severe persistent pain became debilitating. Could not lift arm from side more than 3-6 inches. Needed analgesic for pain every 3-4 hours with only partial relief of pain. Patient experienced a sharp pain immediately on injection saying she explained "oh that hurt!". Upon returning home following the administration of the vaccine (s) she recounted her experience stating what she felt and what she said. She also stated that only the injection in the right arm was painful and that she believed the injection was given higher on the arm close to joint between the upper arm and shoulder. Within two hours the pain started and progressively got worse. Over the count analgesics were taken (TYLENOL then ibuprofen). The pain was mitigated but never totally relieved. 10/5/10/6: Consultation with regular physician by phone; recommended rest, continue OTC meds, heat to affected area. 10/12- Seen in the urgent care center. 10/21-Seen by alternative health care provider (chiropractor).
Age: 31.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: 10/13/10 Pt. called c/o pain and discomfort to L. arm injection site - 10/14/10 Pt. called stated was unable to sleep c/o body aches, fever, increased pain to left arm and that injection site was redder with increased swelling - recommend to follow up with MD - 10/14 PM Saw MD - WBC high. Dr. recommend admitting to hosp. Pt. admitted to hospital - tx. with antibiotics IV for infection. Admitted 12/14/10 to hosp. Released 10/17/10. As per pt. states infection control Dr. stated she had a severe reaction to the PPV23 - 10/19/10 Pt. recovering at home.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: White blood cell count increased
Clinical narrative: 10/13/10 Pt. called c/o pain and discomfort to L. arm injection site - 10/14/10 Pt. called stated was unable to sleep c/o body aches, fever, increased pain to left arm and that injection site was redder with increased swelling - recommend to follow up with MD - 10/14 PM Saw MD - WBC high. Dr. recommend admitting to hosp. Pt. admitted to hospital - tx. with antibiotics IV for infection. Admitted 12/14/10 to hosp. Released 10/17/10. As per pt. states infection control Dr. stated she had a severe reaction to the PPV23 - 10/19/10 Pt. recovering at home.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Infection, Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 10/13/10 Pt. called c/o pain and discomfort to L. arm injection site - 10/14/10 Pt. called stated was unable to sleep c/o body aches, fever, increased pain to left arm and that injection site was redder with increased swelling - recommend to follow up with MD - 10/14 PM Saw MD - WBC high. Dr. recommend admitting to hosp. Pt. admitted to hospital - tx. with antibiotics IV for infection. Admitted 12/14/10 to hosp. Released 10/17/10. As per pt. states infection control Dr. stated she had a severe reaction to the PPV23 - 10/19/10 Pt. recovering at home.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Insomnia, Pain, Pain in extremity, Pyrexia, Vaccination complication
Clinical narrative: 10/13/10 Pt. called c/o pain and discomfort to L. arm injection site - 10/14/10 Pt. called stated was unable to sleep c/o body aches, fever, increased pain to left arm and that injection site was redder with increased swelling - recommend to follow up with MD - 10/14 PM Saw MD - WBC high. Dr. recommend admitting to hosp. Pt. admitted to hospital - tx. with antibiotics IV for infection. Admitted 12/14/10 to hosp. Released 10/17/10. As per pt. states infection control Dr. stated she had a severe reaction to the PPV23 - 10/19/10 Pt. recovering at home.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Asthma, Dyspnoea, Hypersensitivity, Lip swelling, Swelling face
Clinical narrative: Information has been received from a registered medical assistant concerning a 4 year old female patient with BACTRIM allergy, MACRODANTIN allergy, dextrocardia, biliary atresia and ventricular septal defect and no illness at the time of vaccination who on 21-OCT-2010, was vaccinated in the right arm with the second dose of MMR II vaccine (lot#/0156Z,rHA) and on the same day, the patient was vaccinated in the left arm with the second dose of VARIVAX vaccine (Merck) (lot# 668296/0858Z) at 11:15. On 21-OCT-2010 (also reported as 26-OCT-2010), after the vaccination, the patient left the office an 5 minutes later, the patient went back to the office with her father. The patient had facial swelling, swollen lips and difficulty breathing. EPINEPHRINE was administered immediately by the advanced practice registered nurse. The patient was transported to the emergency room via ambulance. The patient was hospitalized for 1 day. On 21-OCT-2010, the patient had recovered. Additional information has been requested. The patient was hospitalized at an Asthma and Allergy Clinic.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Dyspnoea, Lip swelling, Swelling face
Clinical narrative: Information has been received from a registered medical assistant concerning a 4 year old female patient with BACTRIM allergy, MACRODANTIN allergy, dextrocardia, biliary atresia and ventricular septal defect and no illness at the time of vaccination who on 21-OCT-2010, was vaccinated in the right arm with the second dose of MMR II vaccine (lot#/0156Z,rHA) and on the same day, the patient was vaccinated in the left arm with the second dose of VARIVAX vaccine (Merck) (lot# 668296/0858Z) at 11:15. On 21-OCT-2010 (also reported as 26-OCT-2010), after the vaccination, the patient left the office an 5 minutes later, the patient went back to the office with her father. The patient had facial swelling, swollen lips and difficulty breathing. EPINEPHRINE was administered immediately by the advanced practice registered nurse. The patient was transported to the emergency room via ambulance. The patient was hospitalized for 1 day. On 21-OCT-2010, the patient had recovered. Additional information has been requested. The patient was hospitalized at an Asthma and Allergy Clinic.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a registered medical assistant concerning a 4 year old female patient with BACTRIM allergy, MACRODANTIN allergy, dextrocardia, biliary atresia and ventricular septal defect and no illness at the time of vaccination who on 21-OCT-2010, was vaccinated in the right arm with the second dose of MMR II vaccine (lot#/0156Z,rHA) and on the same day, the patient was vaccinated in the left arm with the second dose of VARIVAX vaccine (Merck) (lot# 668296/0858Z) at 11:15. On 21-OCT-2010 (also reported as 26-OCT-2010), after the vaccination, the patient left the office an 5 minutes later, the patient went back to the office with her father. The patient had facial swelling, swollen lips and difficulty breathing. EPINEPHRINE was administered immediately by the advanced practice registered nurse. The patient was transported to the emergency room via ambulance. The patient was hospitalized for 1 day. On 21-OCT-2010, the patient had recovered. Additional information has been requested. The patient was hospitalized at an Asthma and Allergy Clinic.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypersensitivity, Influenza like illness
Clinical narrative: Slight fever, chills, difficulty talking and breathing.  Emergency room treated for reaction.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Dyspnoea, Pyrexia
Clinical narrative: Slight fever, chills, difficulty talking and breathing.  Emergency room treated for reaction.
Age: 66.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Injection site pain, Musculoskeletal stiffness
Clinical narrative: Patient stated on 10/7/2010 that he recieved his vaccine 2 to 4 weeks ago and now feels icky. He had pain at the site up to his left shoulder and it feels stiff. Feels stiff in the hip areas. Patient has been taking aspirin. The nurse encouraged patient to take ibuprofen as needed and increase fluids and seek medical attention if it worse.
Age: 66.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Feeling abnormal, Injection site pain, Joint stiffness, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Patient stated on 10/7/2010 that he recieved his vaccine 2 to 4 weeks ago and now feels icky. He had pain at the site up to his left shoulder and it feels stiff. Feels stiff in the hip areas. Patient has been taking aspirin. The nurse encouraged patient to take ibuprofen as needed and increase fluids and seek medical attention if it worse.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Back pain, Blood creatine phosphokinase MB, Blood test, Chest discomfort
Clinical narrative: Pain at time of injection, pain and numbness traveled down arm into hand w/ in hour. Tightness in chest, difficulty breathing and overall weakness/dizziness.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Differential white blood cell count, Dizziness, Dyspnoea, Electrocardiogram, Full blood count
Clinical narrative: Pain at time of injection, pain and numbness traveled down arm into hand w/ in hour. Tightness in chest, difficulty breathing and overall weakness/dizziness.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Metabolic function test, Pain in extremity, Troponin I
Clinical narrative: Pain at time of injection, pain and numbness traveled down arm into hand w/ in hour. Tightness in chest, difficulty breathing and overall weakness/dizziness.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blood creatine phosphokinase, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Pain at time of injection, pain and numbness traveled down arm into hand w/ in hour. Tightness in chest, difficulty breathing and overall weakness/dizziness.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Electrocardiogram, Full blood count, Hypoaesthesia, Immediate post-injection reaction, Injection site pain
Clinical narrative: Pain at time of injection, pain and numbness traveled down arm into hand w/ in hour. Tightness in chest, difficulty breathing and overall weakness/dizziness.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Laboratory test, Metabolic function test, Pain in extremity, Troponin I
Clinical narrative: Pain at time of injection, pain and numbness traveled down arm into hand w/ in hour. Tightness in chest, difficulty breathing and overall weakness/dizziness.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Acute sinusitis, Asthenia, Chills, Cold sweat, Ear infection
Clinical narrative: My sore throat started immediately following the flu shot and persisted until I got very sick the following week with a virus which included a high temperature, chills, vomiting, weakness, and exhaustion.  The lymph nodes on my left side (same side of injection were very swollen and my armpit was very tender).  After two days of feeling extremely sick, I came down with secondary infections including a lung/bronchial infection, acute sinus infection, and an ear infection (in my left ear).  I went to the doctor for treatment.  Despite being on antiobiotics, I wake up in a cold sweat every night and the tendons in my left arm continue to be very swollen and very painful.  My shoulder aches all the time and it never bothered me until the flu shot with H1N1.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Fatigue, Immediate post-injection reaction, Lung infection, Lymphadenopathy, Malaise
Clinical narrative: My sore throat started immediately following the flu shot and persisted until I got very sick the following week with a virus which included a high temperature, chills, vomiting, weakness, and exhaustion.  The lymph nodes on my left side (same side of injection were very swollen and my armpit was very tender).  After two days of feeling extremely sick, I came down with secondary infections including a lung/bronchial infection, acute sinus infection, and an ear infection (in my left ear).  I went to the doctor for treatment.  Despite being on antiobiotics, I wake up in a cold sweat every night and the tendons in my left arm continue to be very swollen and very painful.  My shoulder aches all the time and it never bothered me until the flu shot with H1N1.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Tenderness, Tendon pain
Clinical narrative: My sore throat started immediately following the flu shot and persisted until I got very sick the following week with a virus which included a high temperature, chills, vomiting, weakness, and exhaustion.  The lymph nodes on my left side (same side of injection were very swollen and my armpit was very tender).  After two days of feeling extremely sick, I came down with secondary infections including a lung/bronchial infection, acute sinus infection, and an ear infection (in my left ear).  I went to the doctor for treatment.  Despite being on antiobiotics, I wake up in a cold sweat every night and the tendons in my left arm continue to be very swollen and very painful.  My shoulder aches all the time and it never bothered me until the flu shot with H1N1.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Vomiting
Clinical narrative: My sore throat started immediately following the flu shot and persisted until I got very sick the following week with a virus which included a high temperature, chills, vomiting, weakness, and exhaustion.  The lymph nodes on my left side (same side of injection were very swollen and my armpit was very tender).  After two days of feeling extremely sick, I came down with secondary infections including a lung/bronchial infection, acute sinus infection, and an ear infection (in my left ear).  I went to the doctor for treatment.  Despite being on antiobiotics, I wake up in a cold sweat every night and the tendons in my left arm continue to be very swollen and very painful.  My shoulder aches all the time and it never bothered me until the flu shot with H1N1.
Age: 41.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Faecal incontinence, Musculoskeletal pain, Neck pain, Paraesthesia, Pruritus
Clinical narrative: Pain in neck and shoulders, heat & severe pain radiating through bicep down to elbow, tingling through finger tips in both arms and sudden itching on palms of both hands.  10/20 09:00: uncontrollable bowels.
Age: 41.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Skin warm
Clinical narrative: Pain in neck and shoulders, heat & severe pain radiating through bicep down to elbow, tingling through finger tips in both arms and sudden itching on palms of both hands.  10/20 09:00: uncontrollable bowels.
Age: 62.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Blood test, Discomfort, Gait disturbance, Injection site pain, Muscle spasms
Clinical narrative: On the day I received the vaccine it felt different from the regular vaccines I have received. I felt a stinging while the needle was in my arm, while the needle was still in my arm, the nurse made an upward twist with the needle. During that time I felt another sting. It hurt so bad it made my whole body flinch. The Nurse said everything was okay and the reason I felt the vaccine that way was because of the medicine in the vaccine. That night, and through out that night I suffered with pain, soreness and  throbbing pain in the arm. The next morning I woke there was still pain throbbing, soreness and discomfort in my left arm. I could hardly move my arm. I could not move my arm above my head without feeling a sharp pain in the muscle where the shot was given. I also began feeling pain in the front and back areas of my shoulder and neck area. When I turn my head there is pain, when I put my head down or try to lift my head, the pain is felt in my arm and travels back up to my neck. I can only sleep on my right side. I have also notice a rash in my face, hives on the top of my head, skin discoloration, swelling in my hands, knees, feet, and ankles. The swelling was so bad I it had affected my ability to walk for at least a week. I have seen three doctors since then. The first doctor was seen on 10-7-10.  I received treatment for muscle spasms; medicine I received was Cyclobenzaprine. I was also given Ketorolac Tromethamine 30 mg. INJ syringe Inject 30 Intramuscular Once. On 10-14-10 Blood work was drawn for some lab test. I was prescribed Tramadol hcl 50 mg, menthol 10%, and methyl salicylate 15% cream for pain. 11-1-10 I was seen by an emergency room doctor. I was treated for shoulder pain and hives. I was given orudis capsules 50mg. for pain. The Doctor said if I did feel any better within 15-20 days to return to private physician. Even though I am taking medications I am still feeling the throbbing pain in my shoulder.
Age: 62.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity, Rash
Clinical narrative: On the day I received the vaccine it felt different from the regular vaccines I have received. I felt a stinging while the needle was in my arm, while the needle was still in my arm, the nurse made an upward twist with the needle. During that time I felt another sting. It hurt so bad it made my whole body flinch. The Nurse said everything was okay and the reason I felt the vaccine that way was because of the medicine in the vaccine. That night, and through out that night I suffered with pain, soreness and  throbbing pain in the arm. The next morning I woke there was still pain throbbing, soreness and discomfort in my left arm. I could hardly move my arm. I could not move my arm above my head without feeling a sharp pain in the muscle where the shot was given. I also began feeling pain in the front and back areas of my shoulder and neck area. When I turn my head there is pain, when I put my head down or try to lift my head, the pain is felt in my arm and travels back up to my neck. I can only sleep on my right side. I have also notice a rash in my face, hives on the top of my head, skin discoloration, swelling in my hands, knees, feet, and ankles. The swelling was so bad I it had affected my ability to walk for at least a week. I have seen three doctors since then. The first doctor was seen on 10-7-10.  I received treatment for muscle spasms; medicine I received was Cyclobenzaprine. I was also given Ketorolac Tromethamine 30 mg. INJ syringe Inject 30 Intramuscular Once. On 10-14-10 Blood work was drawn for some lab test. I was prescribed Tramadol hcl 50 mg, menthol 10%, and methyl salicylate 15% cream for pain. 11-1-10 I was seen by an emergency room doctor. I was treated for shoulder pain and hives. I was given orudis capsules 50mg. for pain. The Doctor said if I did feel any better within 15-20 days to return to private physician. Even though I am taking medications I am still feeling the throbbing pain in my shoulder.
Age: 62.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Skin discolouration, Sleep disorder, Swelling, Urticaria
Clinical narrative: On the day I received the vaccine it felt different from the regular vaccines I have received. I felt a stinging while the needle was in my arm, while the needle was still in my arm, the nurse made an upward twist with the needle. During that time I felt another sting. It hurt so bad it made my whole body flinch. The Nurse said everything was okay and the reason I felt the vaccine that way was because of the medicine in the vaccine. That night, and through out that night I suffered with pain, soreness and  throbbing pain in the arm. The next morning I woke there was still pain throbbing, soreness and discomfort in my left arm. I could hardly move my arm. I could not move my arm above my head without feeling a sharp pain in the muscle where the shot was given. I also began feeling pain in the front and back areas of my shoulder and neck area. When I turn my head there is pain, when I put my head down or try to lift my head, the pain is felt in my arm and travels back up to my neck. I can only sleep on my right side. I have also notice a rash in my face, hives on the top of my head, skin discoloration, swelling in my hands, knees, feet, and ankles. The swelling was so bad I it had affected my ability to walk for at least a week. I have seen three doctors since then. The first doctor was seen on 10-7-10.  I received treatment for muscle spasms; medicine I received was Cyclobenzaprine. I was also given Ketorolac Tromethamine 30 mg. INJ syringe Inject 30 Intramuscular Once. On 10-14-10 Blood work was drawn for some lab test. I was prescribed Tramadol hcl 50 mg, menthol 10%, and methyl salicylate 15% cream for pain. 11-1-10 I was seen by an emergency room doctor. I was treated for shoulder pain and hives. I was given orudis capsules 50mg. for pain. The Doctor said if I did feel any better within 15-20 days to return to private physician. Even though I am taking medications I am still feeling the throbbing pain in my shoulder.
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Chest discomfort, Chest pain, Discomfort, Injection site discomfort, Nasopharyngitis
Clinical narrative: Tight, heavy, dull pain in left side of chest starting about 6.5 hours after the vaccination. Aches in arm. Cold-like symptoms. Immediate feelings of discomfort at time of vaccination (in back of throat, sinuses, left shoulder where shot was administered).
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Tight, heavy, dull pain in left side of chest starting about 6.5 hours after the vaccination. Aches in arm. Cold-like symptoms. Immediate feelings of discomfort at time of vaccination (in back of throat, sinuses, left shoulder where shot was administered).
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Pyrexia, Rash, Screaming, Sleep disorder
Clinical narrative: The next night, 30 hours after the vaccine, she experienced a low grade fever and vomiting. For up to 5 days after the vaccine, she would not sleep very well, scream for no reason, low grade fevers, no appetite, nap for extra time. 3 days later (72 hours later), she developed a body rash on her upper body. 4 days later (96 hours later), she developed a rash on her lower body.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: The next night, 30 hours after the vaccine, she experienced a low grade fever and vomiting. For up to 5 days after the vaccine, she would not sleep very well, scream for no reason, low grade fevers, no appetite, nap for extra time. 3 days later (72 hours later), she developed a body rash on her upper body. 4 days later (96 hours later), she developed a rash on her lower body.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dyskinesia, Muscle twitching
Clinical narrative: Twitching; involuntary muscle movement on right side of face in cheek area. Guest complains of feeling of pulling/twitching going down from right eye to right cheek on face.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Headache, Hypoaesthesia, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Sharp shooting pains in torso and head, slight numbness in finger - next 10 days progressed to whole body, went to E.R. in hospital. Had all types of tests conducted per patient. Labs CT scan and MRI all came out normal, had shot on 10-12-10 - No problems until 10-18-10 (upon which she went to ER). Called pharmacy on 11-12-10.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Sharp shooting pains in torso and head, slight numbness in finger - next 10 days progressed to whole body, went to E.R. in hospital. Had all types of tests conducted per patient. Labs CT scan and MRI all came out normal, had shot on 10-12-10 - No problems until 10-18-10 (upon which she went to ER). Called pharmacy on 11-12-10.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Malaise
Clinical narrative: Patient had a redness at the site of injection till 11/13/10. She felt sick all night & until next morning after getting a vaccine.
Age: 14.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Chills
Clinical narrative: A non-serious spontaneous report of chills has been received from a consumer concerning a 14-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received a single dose of H1N1, Intranasal on 16-Oct-2009. On 20-Oct-2009, the patient developed chills and was sent home from school. The outcome for the reported event was not provided.
Age: 8.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Chills, Feeling cold, Tremor
Clinical narrative: A non-serious spontaneous report of "is cold with chills is shaking" has been received from a consumer concerning an eight-year-old male, subsequent to Influenza A (H1N1) 2009, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received a single dose of Influenza A (H1N1) 2009, Intranasal on 16-Oct-2009. On an unknown date after receiving Influenza A (H1N1) 2009, Intranasal, the patient developed "is cold with chills and is shaking". The outcome of the events was not provided.
Age: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Insomnia
Clinical narrative: A non-serious report of "unable to sleep" has been received from a consumer, patient's mother, concerning a two-year-old female subsequent to H1N1 2009 MONOVALENT vaccine. The patient's medical history and concomitant medications were not reported. The patient received H1N1 MONOVALENT VACCINE before the onset of the event given on 15-Oct-2009. On 15-Oct-2009, the patient was unable to sleep or take naps for four days. On 19-Oct-2009, the event was resolved. On 21-Oct-2009, follow-up information was received: it was clarified whether the reporter is health professional or not and also confirmed that currently, the patient is healthy and sleeping well.
Age: 57.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious, spontaneous report of "gave H1N1 mist to a 57-year-old man" has been received from a registered nurse, subsequent to H1N1 vaccine. The patient's medical history and concomitant medications were not reported. On 21-Oct-2009, the patient received H1N1 Vaccine. The patient is otherwise healthy. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.