chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Right arm was so painful. Never experienced such a reaction as I take flu shots every year. By the evening my entire right arm hung at my side and I couldn't raise it above waist level. 2nd day it was even worse.....so painful. I attribute this to HD Flu vaccine I took for the first time.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death
Clinical narrative: Well child exam on 7-11-12. No problems at birth.
Age: 1.29
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 23 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3608AA received on 03 June 2010, lot number C3682AA received on 06 August 2010, lot number not reported on 12 October 2010 and 20 July 2011 (routes and sites of administration not reported). The subject developed a cough and cold-like symptoms on 02 August 2012, approximately one year after the last dose. On 06 August 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 09 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 10 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 16 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.29
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 23 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3608AA received on 03 June 2010, lot number C3682AA received on 06 August 2010, lot number not reported on 12 October 2010 and 20 July 2011 (routes and sites of administration not reported). The subject developed a cough and cold-like symptoms on 02 August 2012, approximately one year after the last dose. On 06 August 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 09 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 10 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 16 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.26
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 23 August 2012 from the Investigator participating in the post-marketing study under the reference number M5 A16. A case of pertussis in a three-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3200AA received on 17 December 2008, lot number C3228AA received on 13 February 2009, lot number C3284AA received on 17 April 2009 and 1 dose of DAPTACEL; lot number C3192AA received on 18 January 2010 (routes and sites of administration not reported). The subject developed a cough and cold-like symptoms on 24 July 2012, approximately 30 months after the last dose. On 26 July 2012, the subject developed paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 20 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 21 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 21 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 28 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.26
Sex: F
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 23 August 2012 from the Investigator participating in the post-marketing study under the reference number M5 A16. A case of pertussis in a three-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3200AA received on 17 December 2008, lot number C3228AA received on 13 February 2009, lot number C3284AA received on 17 April 2009 and 1 dose of DAPTACEL; lot number C3192AA received on 18 January 2010 (routes and sites of administration not reported). The subject developed a cough and cold-like symptoms on 24 July 2012, approximately 30 months after the last dose. On 26 July 2012, the subject developed paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 20 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 21 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 21 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 28 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.25
Sex: M
Vaccine: DTAPH
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 24 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3588AA received on 01 June 2010, lot number C3615AA received on 30 July 2010 and lot number C3615AA received on 30 September 2010 and 1 dose of TRIHIBIT; lot number U3497BA received on 01 July 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 09 July 2012, approximately one year after the last dose. On 11 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 25 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of amoxicillin/penicillin starting on 19 July 2012 for 7 days. The subject was not hospitalized. At the time of final contact on 27 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.25
Sex: M
Vaccine: DTAPH
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 24 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3588AA received on 01 June 2010, lot number C3615AA received on 30 July 2010 and lot number C3615AA received on 30 September 2010 and 1 dose of TRIHIBIT; lot number U3497BA received on 01 July 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 09 July 2012, approximately one year after the last dose. On 11 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 25 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of amoxicillin/penicillin starting on 19 July 2012 for 7 days. The subject was not hospitalized. At the time of final contact on 27 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Anaphylactic reaction
Clinical narrative: Initial report was received on 23 August 2012 from a health care professional. A 19 year-old female patient with no reported past medical history had received MENACTRA (lot number, route, site and date of administration not reported) "along with two allergy shots" and an unspecified amount of time after vaccination, experienced an Anaphylactic reaction. No further information was provided at the time of the report. The patient's outcome was not reported. The reporter for this case is the same as for cases 2012-07889 (syncope in a 12-year-old female patient) and 2012-07891 (numbness in left limb down to feet in a female patient). Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Aphasia, Condition aggravated, Dysarthria, Dystonia, Immediate post-injection reaction
Clinical narrative: Immediately following injection pt had a dystonic reaction - slurred speech, rt sided facial droop, followed by no speech, unresponsive to verbal & tactile stimulation. VS: BP 139/87 P 131 R 20 O2 100% transported to ED, then to floor on observation status.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Unresponsive to stimuli, VIIth nerve paralysis
Clinical narrative: Immediately following injection pt had a dystonic reaction - slurred speech, rt sided facial droop, followed by no speech, unresponsive to verbal & tactile stimulation. VS: BP 139/87 P 131 R 20 O2 100% transported to ED, then to floor on observation status.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local swelling and redness at shot. (Rt) and (Lt) shot site within 24 hours of vaccination. No Rx needed.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Convulsion
Clinical narrative: Initial report was received from a health care professional on 21 August 2012. A female patient (age and date of birth not reported) had received a dose one injection of PENTACEL (lot number, route, site and date not reported) and an unspecified amount of time later experienced a seizure. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Chest X-ray, Chest pain, Electrocardiogram normal, Full blood count, Metabolic function test
Clinical narrative: Chest pain several hours after vaccine - seen at local ED - ECG, CXR normal. Some chest wall tenderness to palpation. Discharged home. Seen in office 1 week later with normal exam.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Musculoskeletal chest pain
Clinical narrative: Chest pain several hours after vaccine - seen at local ED - ECG, CXR normal. Some chest wall tenderness to palpation. Discharged home. Seen in office 1 week later with normal exam.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Anxiety, Blood test normal, Chest X-ray normal, Chest pain, Electrocardiogram normal
Clinical narrative: Chest pain several hours after vaccine - seen at local ED - ECG, CXR normal. Some chest wall tenderness to palpation. Discharged home. Seen in office 1 week later with normal exam.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Abasia, Dyspnoea, Hypersensitivity, Hypoaesthesia, Miosis
Clinical narrative: 10 AM vacc. (ADACEL) admin. Lt thigh. Pt's only comment was feeling tingly, but OK. 1330 Mom, called ->principal called --> pt. short of breath, arms numb/tingly, pupils very small. Pt's family picked up & took to ER on advice of Dr. Few hours later Mom updated us. States ER phys determined pt hit on/at injection site in P.E., causing allergic response by body. ER MD told Mom not 1st time he had seen this. (of note: pt could not walk at school & at doctor). Also: Twin sister got same vacc w/o problems yesterday.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: 10 AM vacc. (ADACEL) admin. Lt thigh. Pt's only comment was feeling tingly, but OK. 1330 Mom, called ->principal called --> pt. short of breath, arms numb/tingly, pupils very small. Pt's family picked up & took to ER on advice of Dr. Few hours later Mom updated us. States ER phys determined pt hit on/at injection site in P.E., causing allergic response by body. ER MD told Mom not 1st time he had seen this. (of note: pt could not walk at school & at doctor). Also: Twin sister got same vacc w/o problems yesterday.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Pt fainted after injection was given twice in the office. Pt hit head on counter. No tx ness. Pt was reclined and observed in office for over 20 min. Given cold packs and released to mother.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: About 4 min after vx pt dizzy & fainted for a moment. Within a few minutes of laying down, dizziness resolved. This patient tends to faint at sight of blood.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth, Pain
Clinical narrative: 8/20/12- Received Imm. 8/21/12 3:00 AM work up with throbbing, hot, sore (L) arm at injection site - continued to lump at site - 8/22 - reddened area moved to elbow, hotter arm, lump soreness continues.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain, Condition aggravated, Gastrooesophageal reflux disease, Hiccups
Clinical narrative: Pt likely GERD flare up s/p MENACTRA vax - increased hiccuping, inc. abd pain - recurrent GERD sx.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dyspnoea, Pallor
Clinical narrative: Within 5 minutes of receiving vaccine, pt turned pale and began gasping for air she then had a 15-30 second seizure. She was taken to ER via ambulance. Unable to reach parents by phone on 8/3/12 for f/u.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pallor, Presyncope
Clinical narrative: This patient tends to faint. Post Tdap. Pt became pale & looked about to faint & was made to lay down, within 10 minutes, no longer pale. Other vx given (VARIVAX/MENACTRA) but pt made to lay down in between without problem.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Red raised area length 16cm x 11cm wide warm to touch - no rash - able to move arm - full ROM equal hand strength advised to seek rec. of MD.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Small wheel appeared under injection within 5 minutes of injection. Treated with 1/2 tsp of BENADRYL. Parents and pt left within another 5 minutes of treatment of BENADRYL.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Local swelling, Pruritus, Skin discolouration
Clinical narrative: 2-3 days after receiving shingles vaccine, I had a large raised red spot on my left arm; spot was hot, itchy & lasted 6-7 days. I still have a brown spot on my arm.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Pain in extremity
Clinical narrative: (Rt) arm pain, growing erythematous patch (rt) arm at varicella injection site. Dx cellulitis. Treated with Clindamycin.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness, Pallor, Tonic clonic movements
Clinical narrative: Dizzy, the lost consciousness & about 2 sec of tonic-clonic movements of upper & lower extremities. Pale, conscious within 10 sec. No cyanosis.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site swelling, Myalgia, Pain
Clinical narrative: Sore, swollen right deltoid, generalized achiness, headache, chills, and muscle soreness.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Diarrhoea, Injection site rash, Lethargy, Pyrexia, Rash
Clinical narrative: 8/23/12 DIARRHEA 8/24/12 RASH ON FACE  8/25/12 RASH AT INJECTION SITE 8/26/12 LETHARGY 8/27/12 HIGH TEMPERATURE, FEVER ABOVE 100.5
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, soreness, swelling, itching at injection site - began second day - rear upper left arm - grew from armpit to below elbow - itching on 8th day only - redness/swelling lasted two weeks - no other symptoms.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Redness, soreness, swelling, itching at injection site - began second day - rear upper left arm - grew from armpit to below elbow - itching on 8th day only - redness/swelling lasted two weeks - no other symptoms.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Ageusia
Clinical narrative: Loss of taste for 24 hours.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 8-23-2012 el622 Redness, raised, warm to touch. 2" length 1" width. To R arm where varicella inj was administered. Pt denies itching, N/V, stinging, burning to size. Pt stated she noticed spot around 12pm today when fixing hair. Pt was recommended to take Benadryl as directed for age.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Memory impairment
Clinical narrative: SHORT TERM MEMORY AFFECTED 3 TO 5 MONTHS AFTER SHOTS. IS NORMALLY FORGETFUL, BUT INCREASED. HAD GARDASIL #2 08-24-11. GUARDIAN FEELS IT IS DUE TO GARDASIL AND HAS REFUSED #3.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Allergy test, Anxiety, Blood test, Dyspnoea, Feeling hot
Clinical narrative: Throat swelling at least three times a day, rash, restricted breathing, food allergies I have never had before, food intolerance, anxiety attacks, shaking, tremors, hands, tongue, feet and vagina swelling, feeling of warmth all over, toothpaste intolerance, sulfate intolerance.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Food allergy, Food intolerance, Hypersensitivity, Oedema peripheral, Pharyngeal oedema
Clinical narrative: Throat swelling at least three times a day, rash, restricted breathing, food allergies I have never had before, food intolerance, anxiety attacks, shaking, tremors, hands, tongue, feet and vagina swelling, feeling of warmth all over, toothpaste intolerance, sulfate intolerance.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Swollen tongue, Tremor, Ultrasound thyroid, Vulvovaginal swelling
Clinical narrative: Throat swelling at least three times a day, rash, restricted breathing, food allergies I have never had before, food intolerance, anxiety attacks, shaking, tremors, hands, tongue, feet and vagina swelling, feeling of warmth all over, toothpaste intolerance, sulfate intolerance.
Age: 1.25
Sex: M
Vaccine: DTAPH, HEPA, MMR, PPV, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Mild fever off and on for a week, rash appeared at a week.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: PER MOTHER, REDNESS AND SWELLING AT INJECTION SITE WITH BLISTER LIKE LESIONS, AFEBRILE; SEEN BY MD ON 8/23/12. TX WITH ANTIBIOTICS AND DX WITH CELLULITIS.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Patient stated she felt faint and dizzy.  Nurse stated that the patient looked sweaty and pale but did not actually passout.  PT also said she felt sick to her stomach but did not vomit.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood electrolytes normal, Blood glucose normal, Dizziness, Presyncope
Clinical narrative: Near syncope while waiting in the waiting room for 15 minutes post-vaccination. Taken to exam room, BP/HR unremarkable. Placed in Trendelenburg, given OJ. Monitored x 30 minutes; sat up for 5-10 minutes and started feeling faint again. Routed to ER for IVF/observation.
Age: 6.0
Sex: F
Vaccine: IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of injection.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain, redness, and swelling on inner arm from shoulder to elbow.
Age: 60.0
Sex: F
Vaccine: DTAP
Symptoms: Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Itchy, red, blotchy rash on trunk, arms and upper thighs.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling w/ tenderness to arm from injection site to just below elbow. Low grade temp.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Pt calling to state she developed nausea and vomiting with diarrhea yesterday and wonders if this is linked to her Tdap injection she received yesterday.  Pt denies fever, dizziness, visual problems or any other sx.  Pt denies any redness or swelling at the injection site.  Pt states she will increase fluids and monitor sx.  Pt will see medical treatment if sx worsen.  Pt aware we will call tomorrow to check on her sx.  Notified of possible rxn to Adacel vs stomach flu.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema multiforme, Rash pruritic
Clinical narrative: Erythema multiforme on 8/25/12. Treatment included Benadryl 12.5 mg/5ml oral liquid 1.5 tsp q 6h prn itching/rash and orapred ODT, 2 tabs dissolved by mouth qd x 3 days then 1 tab qd for 2 days.
Age: 38.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Headache, nausea, vomiting, pain, redness and swelling to injection left arm.
Age: 38.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Vomiting
Clinical narrative: Headache, nausea, vomiting, pain, redness and swelling to injection left arm.
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient complaining of arm pain and numbness in arm.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: Patient c/o continued pain in arm.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Ear pain, Rash, Swelling face, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Admitted with a dx of chicken pox, c/o swollen of right side of face and ear pain and skin rash.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Child had swelling, redness, warmth and itching to left arm at sites where DTaP and varicella were administered.
Age: 1.02
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL, DTAP, HEP, MMR, PPV
Symptoms: Blood calcium increased, Blood magnesium increased, Blood phosphorus normal, Blood urea normal, Chest X-ray normal
Clinical narrative: Pt was playing when she began to cry, when mom picked her up she noticed that the patient was pale and her lips had turned purple.  It was noted that the patients body went limp for 2-3 minutes and she had a loss of consciousness for 5 seconds.  The patient vomited x 1 but never stopped breathing.  Patient was brought into the ED for work up of syncope and cyanosis.
Age: 1.02
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL, DTAP, HEP, MMR, PPV
Symptoms: Crying, Cyanosis, Hypotonia, Laboratory test, Loss of consciousness
Clinical narrative: Pt was playing when she began to cry, when mom picked her up she noticed that the patient was pale and her lips had turned purple.  It was noted that the patients body went limp for 2-3 minutes and she had a loss of consciousness for 5 seconds.  The patient vomited x 1 but never stopped breathing.  Patient was brought into the ED for work up of syncope and cyanosis.
Age: 1.02
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL, DTAP, HEP, MMR, PPV
Symptoms: Pallor, Platelet count normal, Syncope, Vomiting, White blood cell count normal
Clinical narrative: Pt was playing when she began to cry, when mom picked her up she noticed that the patient was pale and her lips had turned purple.  It was noted that the patients body went limp for 2-3 minutes and she had a loss of consciousness for 5 seconds.  The patient vomited x 1 but never stopped breathing.  Patient was brought into the ED for work up of syncope and cyanosis.
Age: 1.02
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL, DTAP, HEP, MMR, PPV
Symptoms: Dizziness, Lethargy, Loss of consciousness, Pallor, Syncope
Clinical narrative: Pt was playing when she began to cry, when mom picked her up she noticed that the patient was pale and her lips had turned purple.  It was noted that the patients body went limp for 2-3 minutes and she had a loss of consciousness for 5 seconds.  The patient vomited x 1 but never stopped breathing.  Patient was brought into the ED for work up of syncope and cyanosis.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: AT THE INJECTION SITE - PATIENT EXPERIENCED ITCHING, REDNESS AND SWELLING, FEVER AT THE SITE, HARDNESS AND PAIN.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site warmth
Clinical narrative: AT THE INJECTION SITE - PATIENT EXPERIENCED ITCHING, REDNESS AND SWELLING, FEVER AT THE SITE, HARDNESS AND PAIN.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Concussion, Epistaxis, Face and mouth X-ray, Fall, Medical device complication
Clinical narrative: Patient fainted and fell off the examiniation table to the floor, resulting in a concussion, broken orthodontice braces in mouth and bloody nose.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted and fell off the examiniation table to the floor, resulting in a concussion, broken orthodontice braces in mouth and bloody nose.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Fatigue, Muscular weakness, Oropharyngeal pain, Pain
Clinical narrative: Sore and raspy throat at 10:00 pm. Gargled with salt water.  By morning symptoms included a fever of 101.5, body aches, muscle weakness, inability to complete a sentence or think clearly, fatigue.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Speech disorder, Thinking abnormal
Clinical narrative: Sore and raspy throat at 10:00 pm. Gargled with salt water.  By morning symptoms included a fever of 101.5, body aches, muscle weakness, inability to complete a sentence or think clearly, fatigue.
Age: 6.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PPV
Symptoms: Dehydration, Gait disturbance, Headache, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Patient woke up with a fever and sore neck. The fever and sore neck still continues. She also had a slight headache in the night which seemed to be from slight dehydration. She has trouble turning her head from side to side, and up and down. The 4 days directly following the vaccination she had a lot of pain in her legs where the immunizations were done. She had a lot of trouble walking.
Age: 6.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PPV
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Patient woke up with a fever and sore neck. The fever and sore neck still continues. She also had a slight headache in the night which seemed to be from slight dehydration. She has trouble turning her head from side to side, and up and down. The 4 days directly following the vaccination she had a lot of pain in her legs where the immunizations were done. She had a lot of trouble walking.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Nervousness, Pallor, Unresponsive to stimuli
Clinical narrative: Client stated he felt fine while waiting for his sister who had just laid down after she recieved a shot.  He looked nervous and a little pale so I asked him to sit in the chair next to me while I observed his sister.  Sister was fine but he started to be pale so I had him lower his head he then fell against me and was not responding.  His mother took the other side and I asked her to help lower him to the ground.  He remained on the floor with legs bent for about 5-10 minutes while he was recovering. I then asked him if he was able to move on to the exam table next to us and we assisted him to lay down.  He was still needed to remain laid down for about 10 more minutes when he stated he was ok we sat then stood and went to the lobby and sat for 15 more minutes. I gave him some juice and he left feeling fine.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site reaction, Rash vesicular, Swelling
Clinical narrative: 17cm X 10cm area of swelling/redness. Vesicular rash around site appearing 8/30/2012.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Within 2 minutes of injection in right shoulder I experienced pruritus and erythema.  Within 5 minutes the erythema covered the upper half of my arm and extended over my shoulder. Swelling of the injection sight and ~2 cm surrounding the site. Entire deltiod area became hot to the touch. Erythema, pruritus, induration, and hot skin persisted for 5 days.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Within 2 minutes of injection in right shoulder I experienced pruritus and erythema.  Within 5 minutes the erythema covered the upper half of my arm and extended over my shoulder. Swelling of the injection sight and ~2 cm surrounding the site. Entire deltiod area became hot to the touch. Erythema, pruritus, induration, and hot skin persisted for 5 days.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Site of Varicella vaccination very red, painful, swollen.  Indurated area is 4" x 3" in size.  Reaction not noticed night of vaccination though it was very swollen and large upon waking next am.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Her upper arm, slighty below where the shot was given, is very swollen and feels warm to the touch.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Paraesthesia, Pruritus
Clinical narrative: Received ZOSTAVAX on 7/26/20o12. Started having symptoms about 1 week after receiving the shot. Having tingling & burning sensation at waist on left side, same itching and mildly hurting. No rash that she noticed. Came of Pharmacy on 8/13/12 and reported this. Said was bothering her yesterday but no symptoms today - has never had shingles before taking shot.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Diffuse hives. Fever of 100.3.
Age: 1.27
Sex: F
Vaccine: DTAPH
Symptoms: Pyrexia, Rash generalised
Clinical narrative: My 15 month daughter was given 2 shots on 8/28/2012. (Hib and DTaP). My daughter spiked a temperature of 102.9 *F and was told by the Drs office to go to the ER. She was taken to the ER where they gave her 5 ML of ibuprofen to bring the fever down. on 8/31/2012, she broke out in a rash all over her body. Again, the Dr was called and we were told to take her to the ER.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Irritability, Restlessness, Screaming, Somnolence
Clinical narrative: About an hour after receiving three vaccinations, patient was very sleepy and whined more than usual.  After a few minutes of acting restless he started a high pitch screaming fit that lasted about an hour off and on.  There was no fever before or after this occurrence.
Age: 28.0
Sex: M
Vaccine: DT
Symptoms: Injection site swelling, Insomnia, Nausea, Pain, Pyrexia
Clinical narrative: Swelling at site, so much pain it is difficult to sleep creating insomnia, fever of 99.3, nausea.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Pt's (R) thigh became very swollen and extremely red. Swelling as big as moms hand.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Entire right thigh red & swollen. Hot to touch. Patient complains that it hurts. Fever up to 102 degrees.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Auricular swelling, Oedema peripheral, Rash, Rash erythematous, Urticaria
Clinical narrative: Pt. woke up 2 days ago, a day after receiving hepatitis a, with swollen red patches on her arms, legs. By she arrived at the ER 8/21/12 her hands, legs and knees were swollen, ears were swollen as well. She went to ER and was given diphenhydramine and oral steroid. The rash went away, but the next day they appeared as little dots on the face that later became a confluent hive. She went back, to ER, 8/22/12 and was given a prescription for oral steroids for 3 days, today is first day of that. Didn't clear up until today 8/23. No respiratory symptoms. No fever. No lip swelling, no vomiting.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site mass
Clinical narrative: Patient developed large, hard lump at injection site immediately following administration of ZOSTAVAX. I recommended he have it looked at by doctor. Resolved in 3 days.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site mass
Clinical narrative: Patient developed large, hard lump at injection site immediately following administration of ZOSTAVAX. I recommended he have it looked at by doctor. Resolved in 3 days.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Anxiety, Erythema, Local reaction, Local swelling, Pruritus
Clinical narrative: Received TDaP shot. Developed localized swelling, redness, itching. Reaction localized only. Pt anxious as never had reaction before to a vaccine. Notified office 8/31.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Headache, Pyrexia
Clinical narrative: Headache, fever.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Papule, Polymerase chain reaction, Pruritus, Pyrexia, Rash
Clinical narrative: Child developed VRI symptoms with slight fever and rash around 7/4/12. He had small papules scattered on his back, upper chest and thigh. Lesions were itching & suspicious for chicken pox so a sample swab was done & sent to the lab after speaking with the department of health.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Skin lesion, Upper respiratory tract infection, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Child developed VRI symptoms with slight fever and rash around 7/4/12. He had small papules scattered on his back, upper chest and thigh. Lesions were itching & suspicious for chicken pox so a sample swab was done & sent to the lab after speaking with the department of health.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site haematoma, Injection site scar
Clinical narrative: Red scar at the site where the needle penetrated the skin. Around the area is discolored, it looks like a bruise. It appeared after (the same days as the) vaccine was administered.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Swelling, redness, large hive 4x5.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Joint injury, Lip injury, Loss of consciousness, Maternal exposure during pregnancy
Clinical narrative: Patient 9 wks pregnant. Got PF flu shot. She had a flu shot last yr & no problem. Patient passed out outside, but doesn't remember anything. She got scraps on her knee & lip.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Delirium, Pyrexia, Vomiting
Clinical narrative: 8/29/12 11:15am pt had KINRIX (DTaP/IPV combo), MMR and varicella vaccines. Mother called the provider on call 8/30/12 5:30am that pt was delirious, vomiting and had a fever of 103. Given Acetaminophen suppos. and told to give ice pops.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Received ROTATEQ vaccine 8-15-12. Parents started noticing blood in BM's the day after the vaccine given. The blood has continued as of 8-27-12.
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB, FLU3
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Bloody diarrhea next day after vaccines.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Gait disturbance, Myositis, Oedema peripheral, Pain in extremity, Rheumatoid arthritis
Clinical narrative: This case was reported by a physician (also the subject) and described the occurrence of rheumatoid arthritis in a 35-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Concurrent vaccination included hepatitis B vaccine recombinant ;manufacturer unspecified;unknown;unknown given on an unspecified date. In 2003 the subject received 3rd dose of Hepatitis B vaccine (intramuscular, unknown). Three weeks after vaccination with Hepatitis B vaccine, the subject experienced rheumatoid arthritis, hand pain and hand swelling and at an unknown time after vaccination with Hepatitis B vaccine and starting REMICADE, the subject experienced myositis and walking difficulty. Three weeks after the administration of the vaccine the subject developed pains and swelling in hands. Serologic testing was positive for rheumatoid arthritis (rheumatoid factor very high). At that time, the subject was started on PLAQUENIL and prednisone, then methotrexate and at the time of the report was currently on REMICADE. According to the subject, since starting REMICADE, she had now developed myositis "making walking very difficulty" (walking difficulty). The subject did not know which brand hepatitis B vaccine was administered. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Rheumatoid factor increased, Serology positive
Clinical narrative: This case was reported by a physician (also the subject) and described the occurrence of rheumatoid arthritis in a 35-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Concurrent vaccination included hepatitis B vaccine recombinant ;manufacturer unspecified;unknown;unknown given on an unspecified date. In 2003 the subject received 3rd dose of Hepatitis B vaccine (intramuscular, unknown). Three weeks after vaccination with Hepatitis B vaccine, the subject experienced rheumatoid arthritis, hand pain and hand swelling and at an unknown time after vaccination with Hepatitis B vaccine and starting REMICADE, the subject experienced myositis and walking difficulty. Three weeks after the administration of the vaccine the subject developed pains and swelling in hands. Serologic testing was positive for rheumatoid arthritis (rheumatoid factor very high). At that time, the subject was started on PLAQUENIL and prednisone, then methotrexate and at the time of the report was currently on REMICADE. According to the subject, since starting REMICADE, she had now developed myositis "making walking very difficulty" (walking difficulty). The subject did not know which brand hepatitis B vaccine was administered. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Incisional drainage, Pyrexia, Swelling, Vomiting
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 29-year old male patient, with a history of splenectomy and none drug reactions/allergies. The patient was vaccinated with a dose of PNEUMOVAX23 (lot# not reported) 0.5ml, IM in September 2011. No concomitant medications were reported. It was reported the patient experienced swelling, redness, fever and vomiting " a few hours later" after receiving PNEUMOVAX23 dose. The patient went to the ER at a local community hospital but later was transferred to other hospital and the patient was hospitalized. As the treatment the patient had an incision and drainage of fluid in the arm at injection site performed at unspecified date. At the time of report the outcome of patient was recovered, on an unspecified date. The events were considered to be disabling by nurse practitioner. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema of eyelid, Impetigo, Rash
Clinical narrative: FLUMIST given 8-22-12. Seen here for rash & redness left eyelid 8-28-12 and again 8-31-12 with severe impetigo both nares, face, ears & foot.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: 2 days of spreading erythema & induration at vaccination site, with size of erythema 12.7 cm x 8.2 cm after two days. Treated with TYLENOL & BENADRYL.
Age: 14.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Pt fainted after (meningococcal) on left arm. After child woke up, another MA helped me get him on table with nurse assistant. Pt mother & child both admitted that child, didn't eat breakfast, so we gave child juice & crackers = Pt felt better after 15min.
Age: 23.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Myalgia, Pain, Pain in extremity
Clinical narrative: Pt states after getting shot on Friday am her arm became sore that night. Pt states her whole body became sore on Sunday & her muscles hurt all over, but she had no fever, but felt tired. She was advised to call her pvt dr she stated she was using ADVIL for relief & hot showers. 8/21/12 telephone call made to pt with no answer, mom received pt per phoned on 8/23/12 states dr advised if not better in 3 days to come in but pt better now.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Patient called clinic at 12:20 pm 08/31/12 to let us know she developed a hive-like rash last night. She first noticed this before bed. Reports in the middle of the night it was worse and itchy, had spread some over chest. No trouble breathing. Much better today. No allergy medication needed today.
Age: 1.64
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site rash
Clinical narrative: Rash - red papules in cluster surrounding sites on both thighs. Worse on the (L) side. Recommend to call if rxn worsens & see allergist before next dose of VVX.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with the third dose of GARDASIL 2 months after the second dose of GARDASIL. The dates of administration were not available. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to unspecified number of patients of unknown age and gender. In 2012, patients were vaccinated with a dose of GARDASIL (dose, route and lot number not reported) that was improperly stored. Nurse reported that GARDASIL was exposed to temperature as low as -1 C for several occasions from January of 2012 to July of 2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. No treatment information was reported. At the time of report, patient's outcomes were unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The nurse reported that the patient was vaccinated with the first dose of GARDASIL (dose, and route not reported) about a year or two ago (exact date of first dose unspecified). On 16-AUG-2012, the patient was vaccinated with the second dose GARDASIL (dose, and route not reported). No adverse events reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a 19 years old female patient with none pertinent medical history and none drug reactions/allergies. The patient was vaccinated with the GARDASIL the first dose on 17-JUL-2007 (lot # (656049/0187U, Expiration date 29-SEP-2009), the second dose on 21-SEP-2007 (lot # 658560/1062U, Exp date 15-APR-2010) and the third dose on 23-JAN-2008 (lot # 659653/1448U, Expiration date 01-AUG-2010) (doses and routes not reported). No other co-suspects were reported. No concomitant medications were reported., On 31-JUL-2012 the HPV was discovered when the patient had her annual pap smear. The patient sought medical attention by office visit. The outcome of patient was reported as not recovered/not resolved. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Ultrasound abdomen normal
Clinical narrative: This spontaneous report was received from a physician refers to a 4 months old male patient who on an unknown date, was vaccinated with the second dose of ROTATEQ, oral (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that on an unknown date, the patient experienced diarrhea. The patient sought medical attention by having an office visit. No treatment was given for the experience. On an unspecified date, an ultra sound was performed and showed that the bowels were not twisted. It was stated that therapy with ROTATEQ was discontinued and not reintroduced. At the time of the report, the patient's outcome was unknown. The relatedness for patient has his second dose of ROTATEQ and experienced diarrhea was unknown for ROTATEQ, Oral. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. In 2012, patients were vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported) that was improperly stored. Nurse reported that PNEUMOVAX 23 was exposed to temperature as low as -1C for several occasions from January of 2012 to July of 2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. No treatment information was reported. At the time of report, patient's outcomes were unknown. This is one of several reports from the same source. Additional information has been requested.