chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Bottle feeding, Erythema, Swelling face, Tremor
Clinical narrative: Approximately 2 PM, 5-5-10, pt was being bottle fed by his nanny.  Both his hands started shaking & this persisted 4-5 minutes.  Went to sleep after this.  At 4:25 PM, 5-5-10, mother called to report that pt's face was swollen.  Cheeks and one ear bright red.  Sent to ER. This is in follow-up to report(s) previously submitted on 05/06/2010: provided Mfr/imm. proj. reort no.
Age: 51.0
Sex: M
Vaccine: TD
Symptoms: Abdominal pain, Chills, Diarrhoea, Malaise, Pain
Clinical narrative: Awoke with abdominal cramps and sharp pain, had diarrhea; later on in the morning had chills and malaise.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest discomfort, Cough, Feeling abnormal, Hypoaesthesia facial, Nuclear magnetic resonance imaging brain
Clinical narrative: Within one week after injection -  (L) facial numbness, chest heaviness, coughing, felt crummy, foggy thinking, all lasting 4 weeks - sxs improved briefly in 1st 10-14 days after IV Solu Medrol txs x 2 but then worsened again.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Sluggishness
Clinical narrative: Within one week after injection -  (L) facial numbness, chest heaviness, coughing, felt crummy, foggy thinking, all lasting 4 weeks - sxs improved briefly in 1st 10-14 days after IV Solu Medrol txs x 2 but then worsened again.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Received TDAP 6/12/2008 to left deltoid. No other vaccinations given. Last TD 9/9/2005. Complained of sore arm last night that awakened her from sleep, site itches, and over last few hours 6/13 increased warmth, itching and numbness radiating down top of left arm over top of elbow (AC) with radiation to thumb and axilla. No chest pain, fever, SOB, or rash. Seen by immunization tech with site warm to touch with "red streak" - referred for evaluation. Concerned about possible worsening reactions following history similar site soreness with passing out and upcoming weekend. Pt is right handed. Denies any new foods, detergents, deodorants, soaps, lotions, cloths, not outside in grass, etc. No dogs/cats/animal contact. PMH: seasonal allergies, allergy sulfa, flu, hep B, egg astro-rama (surfactant), and thimerasol. Medical problems: migraines, sleep disorders, dry eyes, skin warts, et al. ~Past vaccine reactions: last flu shot in 1993: heavy arm, lymphadenopathy to axillary and clavicular nodes x 1 week. Flu like s/s for 1-2 weeks. Had Hep B series, after third shot July 1993 had following reaction: difficulty breathing, stopped per family, passes out , uncons few moments but unsure while family seeking help, woke up feeling bad. Did have lymph node swelling near shot, redness and sore at site. No rash, fever remembered. Did have body aches with chest sore as it hurt to breathe. Unsure of duration of reaction, no medical f/u sought.~ S/s resolved by day 2 with MOTRIN and warm compress.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Reaction to previous exposure to any vaccine
Clinical narrative: Received TDAP 6/12/2008 to left deltoid. No other vaccinations given. Last TD 9/9/2005. Complained of sore arm last night that awakened her from sleep, site itches, and over last few hours 6/13 increased warmth, itching and numbness radiating down top of left arm over top of elbow (AC) with radiation to thumb and axilla. No chest pain, fever, SOB, or rash. Seen by immunization tech with site warm to touch with "red streak" - referred for evaluation. Concerned about possible worsening reactions following history similar site soreness with passing out and upcoming weekend. Pt is right handed. Denies any new foods, detergents, deodorants, soaps, lotions, cloths, not outside in grass, etc. No dogs/cats/animal contact. PMH: seasonal allergies, allergy sulfa, flu, hep B, egg astro-rama (surfactant), and thimerasol. Medical problems: migraines, sleep disorders, dry eyes, skin warts, et al. ~Past vaccine reactions: last flu shot in 1993: heavy arm, lymphadenopathy to axillary and clavicular nodes x 1 week. Flu like s/s for 1-2 weeks. Had Hep B series, after third shot July 1993 had following reaction: difficulty breathing, stopped per family, passes out , uncons few moments but unsure while family seeking help, woke up feeling bad. Did have lymph node swelling near shot, redness and sore at site. No rash, fever remembered. Did have body aches with chest sore as it hurt to breathe. Unsure of duration of reaction, no medical f/u sought.~ S/s resolved by day 2 with MOTRIN and warm compress.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Pneumococcal vaccine administered to left deltoid. Pt had erythematous rash to medial left arm and left mid-forearm.
Sex: U
Vaccine: HPV4
Symptoms: Congenital anomaly, Drug exposure during pregnancy
Clinical narrative: Information has been received from a health care professional who reported on 16-JUN-2009 normal baby was born with congenital anomaly. The mother of the baby was vaccinated with a first dose of GARDASIL (lot # not reported) on 23-SEP-2009. Also the mother's baby received concomitant therapy MOTRIN and promethazine. At the time of this report, the baby's outcome was unknown. The mother adverse event was capture WAES# 0810USA04931. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Back pain, Dizziness, Pain
Clinical narrative: Initial report received on 11 March 2010 from a health care professional. A 16 year old male patient, with no allergies and no medical history, received a first dose of MENACTRA (lot number unknown) on 04 March 2010. The vaccine was not administered at the reporter's facility. Upon waking on 10 March 2010, the patient experienced back pain from his neck to his tailbone and he had a little dizziness. On 11 March 2010, the back pain continued and was more intense on movement. The patient had no headache and no weakness. He had not taken any medication for the pain. At the time of the report, the patient's recovery status was unknown. Follow-up information was received on 22 April 2010 from a healthcare professional. The MENACTRA lot number was U3012M and the site of injection was the right deltoid. The treatment medication was ibuprofen 600 mg, once every 8 hours as needed. He was expected to return to the clinic 21 April 2010. At the time of this report the patient had not recovered.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a licensed practical nurse, for the Pregnancy Registry for GARDASIL, concerning a 22 year old female with no pertinent medical history, allergies or drug reactions who on 20-MAR-2009 was vaccinated with GARDASIL (lot no., dose and route not reported). The nurse reported that the patient was pregnant when the vaccine was administered. A pregnancy test was performed at the doctor's office that was positive. The patient's LMP was on 20-FEB-2009 and the EDD: 27-NOV-2009. Follow up information has been received from the licensed practical nurse regarding the patient. The nurse stated that the patient's last menstrual period was actually 15-FEB-2009 (previously reported as 20-FEB-2009). On 27-JUL-2009, patient experienced miscarriage at gestational age of 23 weeks. It was asked if there were any previous studies were done following the miscarriage to determine a reason but the nurse said no and mentioned that this was not the patient's first miscarriage. Miscarriage was considered to be an other important medical event. No further information is available.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Burning sensation, Discomfort, Paraesthesia
Clinical narrative: Initial report received on 08 April 2010 from a health care professional. Additional follow-up information was received from a physician on 09 April 2010. A 15-year-old female patient had received a first left arm dose of MENACTRA (lot number U3017AA) on 15 March 2010. Pre-existing medical conditions were reported as acute bronchitis, otitis media, and depression. The patient was using concomitant medications of "ZITHROMAX", PROZAC, and inhaler. It was unclear if the bronchitis and otitis media were concurrent illnesses at time of vaccination on 15 March 2010. Several hours post vaccination (also reported as 7 days post-vaccination) the patient experienced burning, tingling sensation described as if someone was rubbing a dry towel across her back from her head to the sacral area. The sensation was more prominent in the sacral area. The patient was evaluated by a physician the following day, and palpation along the area of sensation caused an increase in discomfort. The sensation had not changed in intensity, had not radiated along any specific dermatome and had not resulted in the development of any abnormal neurological signs on physical examination. No relevant diagnostic tests/laboratory data have been performed at this time. The physician will provide follow-up when more information is available, or when etiology has been established. At the time of this report, the symptoms were still persisting as of 02 April 2010. It was unknown if the patient has recovered.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Rotavirus infection, Vaccination failure
Clinical narrative: Information has been received from a physician concerning an approximately 25 month old female patient who on 05-JUN-2008, 29-JUL-2008 and 30-SEP-2008 was vaccinated with a first, second and third dose of ROTATEQ. Subsequently on an unspecified date the patient experienced rotavirus infection after receiving ROTATEQ. The patient was hospitalized. Subsequently, the patient recovered on an unspecified date and released after treatment. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Back pain, Blindness transient, Convulsion, Diarrhoea
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter who on unspecified dates was vaccinated with 3 doses of GARDASIL (lot number not reported). Concomitant therapy included TOPAMAX (ineffective). After completed the dosing schedule for GARDASIL, in August 2009 the patient experienced severe stomach pain, aches, exhaustion, headaches, blurred vision, back pain, swollen glands, sore throat, fatigue, seizures, high blood pressure and very frequent diarrhea. Around " the end of February 2010", on approximately 28-FEB-2010 the patient was hospitalized because" her right arm and leg went numb and she temporary lost vision". Both events were reported as not being related to seizures. On 05-APR-2010 the patient was air lifted from the hospital to another hospital for seizures. On 10-APR-2010 the patient was sent back to the hospital via an ambulance for seizures again. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Hypertension, Hypoaesthesia, Lymphadenopathy
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter who on unspecified dates was vaccinated with 3 doses of GARDASIL (lot number not reported). Concomitant therapy included TOPAMAX (ineffective). After completed the dosing schedule for GARDASIL, in August 2009 the patient experienced severe stomach pain, aches, exhaustion, headaches, blurred vision, back pain, swollen glands, sore throat, fatigue, seizures, high blood pressure and very frequent diarrhea. Around " the end of February 2010", on approximately 28-FEB-2010 the patient was hospitalized because" her right arm and leg went numb and she temporary lost vision". Both events were reported as not being related to seizures. On 05-APR-2010 the patient was air lifted from the hospital to another hospital for seizures. On 10-APR-2010 the patient was sent back to the hospital via an ambulance for seizures again. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Pain, Vision blurred
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter who on unspecified dates was vaccinated with 3 doses of GARDASIL (lot number not reported). Concomitant therapy included TOPAMAX (ineffective). After completed the dosing schedule for GARDASIL, in August 2009 the patient experienced severe stomach pain, aches, exhaustion, headaches, blurred vision, back pain, swollen glands, sore throat, fatigue, seizures, high blood pressure and very frequent diarrhea. Around " the end of February 2010", on approximately 28-FEB-2010 the patient was hospitalized because" her right arm and leg went numb and she temporary lost vision". Both events were reported as not being related to seizures. On 05-APR-2010 the patient was air lifted from the hospital to another hospital for seizures. On 10-APR-2010 the patient was sent back to the hospital via an ambulance for seizures again. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Bradycardia, Death, Endotracheal intubation, Presyncope, Respiratory distress
Clinical narrative: Child had been in distress at cardiology office - was transported to hospital. When intubated for transport child had vagal response with bradycardia - unable to resuscitate and child expired at ER.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Resuscitation
Clinical narrative: Child had been in distress at cardiology office - was transported to hospital. When intubated for transport child had vagal response with bradycardia - unable to resuscitate and child expired at ER.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Oedema peripheral, Rash
Clinical narrative: Severely swollen left arm. Small rash on left side of back. MOTRIN/BENADRYL/Prednisone (given by ER).
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Hypoaesthesia, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient had a headache and fever of 101 degrees, numbness from his shoulder down to elbow. The injection site was swollen, measuring 14x9 cm and later in the evening 14x12 cm. The site was warm, red, painful and hardened. Steroids, BENADRYL and pain meds given at Emergency Room.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient had a headache and fever of 101 degrees, numbness from his shoulder down to elbow. The injection site was swollen, measuring 14x9 cm and later in the evening 14x12 cm. The site was warm, red, painful and hardened. Steroids, BENADRYL and pain meds given at Emergency Room.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Discomfort, Herpes zoster, Injection site rash
Clinical narrative: 3/26/10 - Rash where vaccine was injected. Swollen for 2 days. 4/15/10 - Had shingles on left foot, 3 spots. They blistered & still have some discomfort. Had shingles in 1/93. Had to go to Pain Clinic to ease nerve pain. Still go every year for an injection from bone spurs that formed after shingles.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: 3/26/10 - Rash where vaccine was injected. Swollen for 2 days. 4/15/10 - Had shingles on left foot, 3 spots. They blistered & still have some discomfort. Had shingles in 1/93. Had to go to Pain Clinic to ease nerve pain. Still go every year for an injection from bone spurs that formed after shingles.
Age: 58.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Immediate post-injection reaction, Injection site reaction
Clinical narrative: Immediate local reaction to site.  After cleansing site with alcohol I gave shot.  At first it was "pea" sized reaction but within 5 min was large grape.  Denies itching or pain.
Sex: U
Vaccine: TDAP
Symptoms: Radiculitis brachial
Clinical narrative: Initial report was received 26 April 2010 from a health care professional. An adult patient (age reported as in their mid 40s), had received an injection of ADACEL (lot number, route, site and date of administration not reported) and an unspecified amount of time later, the patient developed a severe reaction which prompted the physician to call 911. The physician and nurse believed that the patient developed brachial neuritis (transient) which resolved after four to five hours. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Head injury, Syncope, X-ray normal
Clinical narrative: After being given vaccine pt had syncopal episode hitting face/head on wall/floor.
Age: 61.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Malaise, Muscle spasms, Myalgia, Pain
Clinical narrative: Patient had flu shot an then started to feel ill with aches and pains, leg cramps. Symptoms: Symptoms: 1. Myalgia. 2. pain Treatment Drugs Used: 1 - DIPHENHYDRAMINE Dose: 25 Units: MG Freq: ONCE Route: IV. 2 - METHYLPREDNISOLONE Dose: 125 Units: MG Freq: ONCE Route: IV. 3 - KETOROLAC TROMETHAMINE Dose: 30 Units: MG Freq: ONCE Route: IV
Age: 4.0
Sex: M
Vaccine: HEPA, IPV
Symptoms: Cough, Lip swelling
Clinical narrative: Mom was shopping with the child, his hip started to swell and he had a bit of a cough. Mom gave him BENADRYL, symptoms improved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Received Dtap, IPV, MMR, Varivax on 05/05/10. C/o leg pain 05/06/10 pm. Left thigh very red, warm, firm, and painful.  Induration 10.1x10.6 cm.  Pt received IPV and Varivax inj. in that leg.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Soreness, redness and large welt developed. Site hot and painful. 5/5-5/7 worsening with increased area of redness, swelling and pain. Now transverses the arm. Worsening despite heat/ice therapy.  Taking Celebrex already.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Limb discomfort, Pain, Urticaria
Clinical narrative: Soreness, redness and large welt developed. Site hot and painful. 5/5-5/7 worsening with increased area of redness, swelling and pain. Now transverses the arm. Worsening despite heat/ice therapy.  Taking Celebrex already.
Age: 17.0
Sex: M
Vaccine: FLU(H1N1), FLU3, HPV4, PPV, TDAP
Symptoms: Oedema peripheral, Throat irritation
Clinical narrative: Pts mother called 5-7-10 stating that pt had swelling in (R) arm and under (R) armpit and throat irritation.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Edema, erythema at and 10 cm distal to injection site.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: C-reactive protein normal, Grip strength decreased, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient c/o numbness, tingling & inability to grasp/grip with bilateral hands. Has sensation to hands but states "it feels like my hands are asleep." These symptoms started roughly 2 1/2 to 3 hours post vaccination.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Lymphadenopathy, Oedema peripheral, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Child had fever x 1 day and painful arm swelling to 8 cm by 4cm with axillary adenopathy. All tender-possible cellulitis.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: After 5th dose of DTAP pt c/o redness & swelling at injection site; Pt. was seen in the office 5.7.10 (3 days post injection).  Diagnoses:  Vaccine reaction.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Gait disturbance, Injection site induration
Clinical narrative: Firm area to left thigh with pain for the last 2 days. Refusing to walk.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Fever up to 101, body aches, joint pains, fatigue, nausea and vomiting.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Fever up to 101, body aches, joint pains, fatigue, nausea and vomiting.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Abasia, Gait disturbance, Irritability, Joint swelling, Oedema peripheral
Clinical narrative: Fever 100 and above, extreme swollen leg and knee, child unable to walk due to pain.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Pain, Pyrexia
Clinical narrative: Fever 100 and above, extreme swollen leg and knee, child unable to walk due to pain.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Erythema, Joint swelling, Oedema peripheral
Clinical narrative: Fever 100 and above, extreme swollen leg and knee, child unable to walk due to pain.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Abasia, Gait disturbance, Irritability, Joint swelling, Oedema peripheral
Clinical narrative: Thigh and knee swelling and redness.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Pain, Pyrexia
Clinical narrative: Thigh and knee swelling and redness.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Erythema, Joint swelling, Oedema peripheral
Clinical narrative: Thigh and knee swelling and redness.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Localized swelling and redness 3 cm on 5/5/10, baseball sized area by afternoon of 5/6/10.  No fever, pain or other sx.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Nausea, Vomiting
Clinical narrative: Onset of Nausea/Vomiting, later in day area became reddened and hard to touch.
Age: 1.34
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Local reaction
Clinical narrative: Enlarge reaction-localized 2 1/2 x 2 1/2" Rx supportive/ warm compresses/BENADRYL 4/14/10.
Age: 37.0
Sex: F
Vaccine: YF
Symptoms: Balance disorder, Dizziness, Nausea
Clinical narrative: Dizziness, nausea, lost sense of balance.
Age: 32.0
Sex: F
Vaccine: HEPAB
Symptoms: Abdominal pain upper, Anxiety, Blood test normal, Computerised tomogram normal, Condition aggravated
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible allergic reaction in a 32-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline) for international travel. The subject's medical history included anxiety disorder and penicillin allergy. There was also possible pre-existing fatigue. The subject received no concomitant vaccinations and was not taking any medications. On 29 March 2010 at 11:27 the subject received 1st dose of TWINRIX (1 ml, unknown route, left deltoid). On 29 March 2010 at 13:10, less than one day after vaccination with TWINRIX, the subject experienced possible allergic reaction. She had arm tingling, tremor and difficulty breathing. The subject was treated with oxygen and ADRENALINE, and was placed in Trendelenberg position. Ambulance personnel administered BENADRYL and IV fluid(s). The subject also experienced throat tightness, but was vocal, verbal, anxious and shouting. She was stable, without respiratory distress, but very upset. The subject was taken to the Emergency Room and on arrival pulse oxygen was 99% on room air, blood pressure was 140/71, pulse rate was 122 and respiratory rate was 22. Later the pulse rate was 103, blood pressure 120/73, respiratory rate 16 and pulse oxygen 99% on room air. The subject was alert, oriented and upset. There was no wheezing, no cyanosis, no spleen or hepatic swelling, and no muscle weakness. The subject was treated with PEPCID and ATIVAN. She was discharged from ER after midnight that same night in stable condition. The subject experienced shortness of breath the next morning (30 March 2010) and treatment with PEPCID resulting in resolution of symptoms. At time of reporting, the events resolved on an unspecified date. Follow-up information received 04 May 2010: On 03 May 2010, the subject informed the healthcare professional that she continued to feel unwell. She had visited several physicians and had been treated with additional steroids. Blood tests, liver enzyme tests and autoimmune tests were negative. Ultrasound of the liver and gallbladder and a CAT scan of the liver were without significant findings. The subject also experienced lack of appetite, easily fatigued and pain in right upper quadrant below the right rib; at the time of reporting, these events were unresolved. The subject reported that her physician has discontinued all medications and is looking to see "why her body is acting like she has Hepatitis". This case was assessed as medically serious by GSK. This case was assessed as medically serious by GSK. At the time of reporting, the events of feeling unwell, lack of appetite, easily fatigued and pain in right upper quadrant were unresolved. The outcome of the hepatitis-like symptoms was unspecified. The vaccination course with TWINRIX was discontinued. The healthcare professional reported that two other patients were administered TWINRIX on the same day as this subject and from the same batch, without any complications.
Age: 32.0
Sex: F
Vaccine: HEPAB
Symptoms: Decreased appetite, Dyspnoea, Emotional distress, Fatigue, Immunology test normal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible allergic reaction in a 32-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline) for international travel. The subject's medical history included anxiety disorder and penicillin allergy. There was also possible pre-existing fatigue. The subject received no concomitant vaccinations and was not taking any medications. On 29 March 2010 at 11:27 the subject received 1st dose of TWINRIX (1 ml, unknown route, left deltoid). On 29 March 2010 at 13:10, less than one day after vaccination with TWINRIX, the subject experienced possible allergic reaction. She had arm tingling, tremor and difficulty breathing. The subject was treated with oxygen and ADRENALINE, and was placed in Trendelenberg position. Ambulance personnel administered BENADRYL and IV fluid(s). The subject also experienced throat tightness, but was vocal, verbal, anxious and shouting. She was stable, without respiratory distress, but very upset. The subject was taken to the Emergency Room and on arrival pulse oxygen was 99% on room air, blood pressure was 140/71, pulse rate was 122 and respiratory rate was 22. Later the pulse rate was 103, blood pressure 120/73, respiratory rate 16 and pulse oxygen 99% on room air. The subject was alert, oriented and upset. There was no wheezing, no cyanosis, no spleen or hepatic swelling, and no muscle weakness. The subject was treated with PEPCID and ATIVAN. She was discharged from ER after midnight that same night in stable condition. The subject experienced shortness of breath the next morning (30 March 2010) and treatment with PEPCID resulting in resolution of symptoms. At time of reporting, the events resolved on an unspecified date. Follow-up information received 04 May 2010: On 03 May 2010, the subject informed the healthcare professional that she continued to feel unwell. She had visited several physicians and had been treated with additional steroids. Blood tests, liver enzyme tests and autoimmune tests were negative. Ultrasound of the liver and gallbladder and a CAT scan of the liver were without significant findings. The subject also experienced lack of appetite, easily fatigued and pain in right upper quadrant below the right rib; at the time of reporting, these events were unresolved. The subject reported that her physician has discontinued all medications and is looking to see "why her body is acting like she has Hepatitis". This case was assessed as medically serious by GSK. This case was assessed as medically serious by GSK. At the time of reporting, the events of feeling unwell, lack of appetite, easily fatigued and pain in right upper quadrant were unresolved. The outcome of the hepatitis-like symptoms was unspecified. The vaccination course with TWINRIX was discontinued. The healthcare professional reported that two other patients were administered TWINRIX on the same day as this subject and from the same batch, without any complications.
Age: 32.0
Sex: F
Vaccine: HEPAB
Symptoms: Liver function test normal, Malaise, Paraesthesia, Screaming, Throat tightness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible allergic reaction in a 32-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline) for international travel. The subject's medical history included anxiety disorder and penicillin allergy. There was also possible pre-existing fatigue. The subject received no concomitant vaccinations and was not taking any medications. On 29 March 2010 at 11:27 the subject received 1st dose of TWINRIX (1 ml, unknown route, left deltoid). On 29 March 2010 at 13:10, less than one day after vaccination with TWINRIX, the subject experienced possible allergic reaction. She had arm tingling, tremor and difficulty breathing. The subject was treated with oxygen and ADRENALINE, and was placed in Trendelenberg position. Ambulance personnel administered BENADRYL and IV fluid(s). The subject also experienced throat tightness, but was vocal, verbal, anxious and shouting. She was stable, without respiratory distress, but very upset. The subject was taken to the Emergency Room and on arrival pulse oxygen was 99% on room air, blood pressure was 140/71, pulse rate was 122 and respiratory rate was 22. Later the pulse rate was 103, blood pressure 120/73, respiratory rate 16 and pulse oxygen 99% on room air. The subject was alert, oriented and upset. There was no wheezing, no cyanosis, no spleen or hepatic swelling, and no muscle weakness. The subject was treated with PEPCID and ATIVAN. She was discharged from ER after midnight that same night in stable condition. The subject experienced shortness of breath the next morning (30 March 2010) and treatment with PEPCID resulting in resolution of symptoms. At time of reporting, the events resolved on an unspecified date. Follow-up information received 04 May 2010: On 03 May 2010, the subject informed the healthcare professional that she continued to feel unwell. She had visited several physicians and had been treated with additional steroids. Blood tests, liver enzyme tests and autoimmune tests were negative. Ultrasound of the liver and gallbladder and a CAT scan of the liver were without significant findings. The subject also experienced lack of appetite, easily fatigued and pain in right upper quadrant below the right rib; at the time of reporting, these events were unresolved. The subject reported that her physician has discontinued all medications and is looking to see "why her body is acting like she has Hepatitis". This case was assessed as medically serious by GSK. This case was assessed as medically serious by GSK. At the time of reporting, the events of feeling unwell, lack of appetite, easily fatigued and pain in right upper quadrant were unresolved. The outcome of the hepatitis-like symptoms was unspecified. The vaccination course with TWINRIX was discontinued. The healthcare professional reported that two other patients were administered TWINRIX on the same day as this subject and from the same batch, without any complications.
Age: 32.0
Sex: F
Vaccine: HEPAB
Symptoms: Tremor, Ultrasound biliary tract, Ultrasound liver normal, Ultrasound scan normal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible allergic reaction in a 32-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline) for international travel. The subject's medical history included anxiety disorder and penicillin allergy. There was also possible pre-existing fatigue. The subject received no concomitant vaccinations and was not taking any medications. On 29 March 2010 at 11:27 the subject received 1st dose of TWINRIX (1 ml, unknown route, left deltoid). On 29 March 2010 at 13:10, less than one day after vaccination with TWINRIX, the subject experienced possible allergic reaction. She had arm tingling, tremor and difficulty breathing. The subject was treated with oxygen and ADRENALINE, and was placed in Trendelenberg position. Ambulance personnel administered BENADRYL and IV fluid(s). The subject also experienced throat tightness, but was vocal, verbal, anxious and shouting. She was stable, without respiratory distress, but very upset. The subject was taken to the Emergency Room and on arrival pulse oxygen was 99% on room air, blood pressure was 140/71, pulse rate was 122 and respiratory rate was 22. Later the pulse rate was 103, blood pressure 120/73, respiratory rate 16 and pulse oxygen 99% on room air. The subject was alert, oriented and upset. There was no wheezing, no cyanosis, no spleen or hepatic swelling, and no muscle weakness. The subject was treated with PEPCID and ATIVAN. She was discharged from ER after midnight that same night in stable condition. The subject experienced shortness of breath the next morning (30 March 2010) and treatment with PEPCID resulting in resolution of symptoms. At time of reporting, the events resolved on an unspecified date. Follow-up information received 04 May 2010: On 03 May 2010, the subject informed the healthcare professional that she continued to feel unwell. She had visited several physicians and had been treated with additional steroids. Blood tests, liver enzyme tests and autoimmune tests were negative. Ultrasound of the liver and gallbladder and a CAT scan of the liver were without significant findings. The subject also experienced lack of appetite, easily fatigued and pain in right upper quadrant below the right rib; at the time of reporting, these events were unresolved. The subject reported that her physician has discontinued all medications and is looking to see "why her body is acting like she has Hepatitis". This case was assessed as medically serious by GSK. This case was assessed as medically serious by GSK. At the time of reporting, the events of feeling unwell, lack of appetite, easily fatigued and pain in right upper quadrant were unresolved. The outcome of the hepatitis-like symptoms was unspecified. The vaccination course with TWINRIX was discontinued. The healthcare professional reported that two other patients were administered TWINRIX on the same day as this subject and from the same batch, without any complications.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received KINRIX on 5/4/2010. On 5/6/10 developed pain,swelling, red, tender and warm to touch recommend ice, range of motion, ibuprofen.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site infection
Clinical narrative: Likely cellulitis due to superinfection of TDAP injection site.  Perimeter drawn around border start cephalexin 250 mg / 5 ml 4 tsp bid.  Call if worsening redness, fever, other concerns.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Patient was given DTAP instead of TDAP.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Alopecia, Blood test, Body temperature increased, Depression
Clinical narrative: Severe abdominal pain, rash, hair loss, black spots before eyes, body temperature being too hot, constant illness, weak immune system, vomiting, dizziness, fatigue, depression.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Fatigue, Immune system disorder, Malaise, Rash
Clinical narrative: Severe abdominal pain, rash, hair loss, black spots before eyes, body temperature being too hot, constant illness, weak immune system, vomiting, dizziness, fatigue, depression.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Visual impairment, Vomiting
Clinical narrative: Severe abdominal pain, rash, hair loss, black spots before eyes, body temperature being too hot, constant illness, weak immune system, vomiting, dizziness, fatigue, depression.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test, Unevaluable event
Clinical narrative: Severe abdominal pain, rash, hair loss, black spots before eyes, body temperature being too hot, constant illness, weak immune system, vomiting, dizziness, fatigue, depression.
Age: 46.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Fatigue, Grip strength decreased, Injection site pain
Clinical narrative: Patient c/o Rt arm pain post H1N1 vaccine dose. Patient has had "sore", "aches" on Rt arm since administration. Stated, "Hurts on and off all day". Has full ROM, pain with lifting arm at 45 degree angle, has fatigue, "hard to pick up things at times". Has taken MOTRIN po per home meds around the clock since vaccine. Denies muscle spasm/rxn at site/swelling.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Seasonal flu vaccine to left arm on 10/19/2009. Pain at the site worsening by 10/23. When arm is immoble like during sleep it becomes very weak and very sore. Went to see PCP on 10/31 (Sat.) referred for physical therapy. MOTRIN helps relieve pain to some degree.
Age: 39.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Fatigue, Grip strength decreased, Pain, Pain in extremity
Clinical narrative: Patient received Influenza vaccine on 10/13/2009 in (L) deltoid; next day in A.M. arm was "sore", has been up to today. C/O fatigue with raising (L) arm, pain putting clothes on with MOTRIN, has full ROM, pain starts at 45 degree angle, decreased grip in (L) hand intermittently. Denies muscle spasms, rxn at site or swelling. Has taken MOTRIN OTC per home meds RTC since vaccine. Has applied heat to arm with no relief.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Blood creatine phosphokinase, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Seasonal flu shot-right arm-was sore for a few days then started to get some numbness and tingling in right arm and some periodic weakness in right arm.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Seasonal flu shot-right arm-was sore for a few days then started to get some numbness and tingling in right arm and some periodic weakness in right arm.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy, Hypoaesthesia facial, Injection site pain
Clinical narrative: Bells palsy to right of face and numbness to left side of face.  Pain at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site dryness, Injection site erythema, Injection site swelling
Clinical narrative: Swelling of the right upper arm after DTAP was given 24 hours ago. It is itchy and red.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Hypoaesthesia oral, Rash
Clinical narrative: Rash on face, lips numb, "feels hot", patient went to the emergency room.
Age: 18.0
Sex: M
Vaccine: HEPA, MEN, HEPA, MEN
Symptoms: Cold sweat, Gaze palsy, Headache, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Pt passed out right afte giving 3 injection-eyes rolled, legs stiff, hands shaking, skin pale and wet-called for dr and crashcart-upon Dr entering the room, Pt coming to and answering questions-elevated legs, soda, crackers given and monitored Pt for 1hr-Pt complained of headache and itching all over-Pt left at noon with no symptoms.
Age: 18.0
Sex: M
Vaccine: HEPA, MEN, HEPA, MEN
Symptoms: Musculoskeletal stiffness, Pallor, Pruritus generalised, Tremor
Clinical narrative: Pt passed out right afte giving 3 injection-eyes rolled, legs stiff, hands shaking, skin pale and wet-called for dr and crashcart-upon Dr entering the room, Pt coming to and answering questions-elevated legs, soda, crackers given and monitored Pt for 1hr-Pt complained of headache and itching all over-Pt left at noon with no symptoms.
Age: 18.0
Sex: M
Vaccine: HEPA, MEN, HEPA, MEN
Symptoms: Convulsion, Headache, Malaise, Scratch, Somnolence
Clinical narrative: Pt passed out right afte giving 3 injection-eyes rolled, legs stiff, hands shaking, skin pale and wet-called for dr and crashcart-upon Dr entering the room, Pt coming to and answering questions-elevated legs, soda, crackers given and monitored Pt for 1hr-Pt complained of headache and itching all over-Pt left at noon with no symptoms.
Age: 18.0
Sex: M
Vaccine: HEPA, MEN, HEPA, MEN
Symptoms: Throat tightness, Tongue disorder, Urticaria
Clinical narrative: Pt passed out right afte giving 3 injection-eyes rolled, legs stiff, hands shaking, skin pale and wet-called for dr and crashcart-upon Dr entering the room, Pt coming to and answering questions-elevated legs, soda, crackers given and monitored Pt for 1hr-Pt complained of headache and itching all over-Pt left at noon with no symptoms.
Age: 1.26
Sex: M
Vaccine: HEPA
Symptoms: Body temperature increased, Chest X-ray normal, Chills, Culture urine negative, Dyspnoea
Clinical narrative: Felt very hot, shivering, difficulty breathing later on.  When we had a chance to use a thermometer his temp was 106.6 at about 10pm.  Went straight to ER at that point and they gave Motrin and treated it like a UTI, but when results came back 3 days later, it was not a UTI.
Age: 1.26
Sex: M
Vaccine: HEPA
Symptoms: Feeling hot, Urine analysis normal, Viral infection
Clinical narrative: Felt very hot, shivering, difficulty breathing later on.  When we had a chance to use a thermometer his temp was 106.6 at about 10pm.  Went straight to ER at that point and they gave Motrin and treated it like a UTI, but when results came back 3 days later, it was not a UTI.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Mild rash spreading slowly and itching. So far 4am - 5:30pm.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, FLU(H1N1), HIBV, PNC, RV5
Symptoms: Culture urine negative, Febrile convulsion, Pyrexia, Urine analysis normal
Clinical narrative: The patient had his vaccines for 6 months of age and H1N1 vaccine on 5/3/10. He started having fever and two episodes of febrile seizures in the early morning of 5/4/10 (within 24 hours). The patient was seen in ER at medical center on 5/4/10.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Body temperature increased, Dizziness, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: ( L ) forearm 4.25" x 2.25" ( L ) anterior deltoid. Erythema, warmth, induration occurred 24 hrs post injection. Injection given 5/3/2010 @ 4:30 pm. Had 1 temp 101 F @ 6 pm that night & dizziness at 2 pm on 5/4/2010. Both have resolved. Treated with Trimethoprim Sulfamethoxazole for possible cellulitis.
Age: 1.57
Sex: M
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Area of induration and redness/swelling 3cm x 3cm anterior right thigh.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 4 cm localized redness, warmth, induration at injection site post Varicella vaccination 2 days ago. Unknown onset of symptoms.  Follow up - The actual onset of symptoms was not available but was reported to MD on 5/3/10, no specific time was given.
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site macule, Injection site papule
Clinical narrative: -INFANRIX administered in right thigh on 5/3/2010. -Developed rough/erythema which maculopapular eruption at injection site over most of right thigh-not entirely circumferential-treated with TYLENOL and ice.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Cyanosis, Oxygen saturation normal, Pallor
Clinical narrative: Following PEDIARIX vaccine he cries briefly, turned cyanotic, then pale. He was quiet briefly, then fully recovered. Pulse ox always was 100%.
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None Reported
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Ear disorder, Facial palsy, Hyperacusis, Hypoaesthesia facial
Clinical narrative: Vaccine received on Friday 9-4 2PM - 9-18 PM - taste buds were gone - increased hearing in left ear. Sat 9-19 woke up with left side of face drooping and numb. Eye, mouth drooping - couldn't close left eye - Sawn general physician on Tues 9-22 - Rx VALTREX and Prednisone - 2nd course of Prednisone - still no resolution of symptoms. Saw my Lyme Dr. on 10-8 (Also saw ophthalmologist for eye).
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Impaired driving ability, Loss of consciousness, Road traffic accident
Clinical narrative: Patient got vaccine, while being observed she slept for 1 hour in waiting room, then began to drive herself home. Lost consciousness while driving and ran into guard rail - doesn't remember feeling faint or dizzy or sleepy before LOC.
Age: 49.0
Sex: F
Vaccine: TDAP, TTOX
Symptoms: Angiogram, Computerised tomogram abnormal, Dizziness, Electrocardiogram normal, Headache
Clinical narrative: Around 8pm of Feb 16, 2010, I started to feel pain on my injection site and swelling/redness noted. The following day Feb 17, the swelling/redness getting bigger and harder, more pain, I'm having a temp, epigastric pain, nausea and vomiting. The following day Feb 18, same thing but w/ shortness of breath and chest pain, so I was brought to hosp via 911. CT chest was done and found PE on my left lower lobe. Lovenox and Coumadin was started. Presently, I'm still on Coumadin 4mg daily.
Age: 49.0
Sex: F
Vaccine: TDAP, TTOX
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, International normalised ratio
Clinical narrative: Around 8pm of Feb 16, 2010, I started to feel pain on my injection site and swelling/redness noted. The following day Feb 17, the swelling/redness getting bigger and harder, more pain, I'm having a temp, epigastric pain, nausea and vomiting. The following day Feb 18, same thing but w/ shortness of breath and chest pain, so I was brought to hosp via 911. CT chest was done and found PE on my left lower lobe. Lovenox and Coumadin was started. Presently, I'm still on Coumadin 4mg daily.
Age: 49.0
Sex: F
Vaccine: TDAP, TTOX
Symptoms: Nausea, Prothrombin time, Pulmonary embolism, Pyrexia, Swelling
Clinical narrative: Around 8pm of Feb 16, 2010, I started to feel pain on my injection site and swelling/redness noted. The following day Feb 17, the swelling/redness getting bigger and harder, more pain, I'm having a temp, epigastric pain, nausea and vomiting. The following day Feb 18, same thing but w/ shortness of breath and chest pain, so I was brought to hosp via 911. CT chest was done and found PE on my left lower lobe. Lovenox and Coumadin was started. Presently, I'm still on Coumadin 4mg daily.
Age: 49.0
Sex: F
Vaccine: TDAP, TTOX
Symptoms: Ultrasound scan normal, Vomiting
Clinical narrative: Around 8pm of Feb 16, 2010, I started to feel pain on my injection site and swelling/redness noted. The following day Feb 17, the swelling/redness getting bigger and harder, more pain, I'm having a temp, epigastric pain, nausea and vomiting. The following day Feb 18, same thing but w/ shortness of breath and chest pain, so I was brought to hosp via 911. CT chest was done and found PE on my left lower lobe. Lovenox and Coumadin was started. Presently, I'm still on Coumadin 4mg daily.
Age: 49.0
Sex: F
Vaccine: TDAP, TTOX
Symptoms: Abdominal pain upper, Body temperature increased, Chest pain, Computerised tomogram abnormal, Dyspnoea
Clinical narrative: Around 8pm of Feb 16, 2010, I started to feel pain on my injection site and swelling/redness noted. The following day Feb 17, the swelling/redness getting bigger and harder, more pain, I'm having a temp, epigastric pain, nausea and vomiting. The following day Feb 18, same thing but w/ shortness of breath and chest pain, so I was brought to hosp via 911. CT chest was done and found PE on my left lower lobe. Lovenox and Coumadin was started. Presently, I'm still on Coumadin 4mg daily.