chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TYP, YF, HEPA, HPV4, MNQ, TYP, YF
Symptoms: Pallor, Posture abnormal, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 18 years old female patient with no previous illness and no medical history who on 14-MAY-2012, was vaccinated IM in the right arm with the second dose of GARDASIL (lot# 671994/1537AA, exp 21-JUN-2012). Concomitant vaccines given on the same day included the first dose of TYPHIM VI (lot# G11241) given IM in the left arm, the second dose of HAVRIX (lot# AHAVB550AA) given IM in the right arm, the first dose of YF-VAX (lot# UH276AA) given SQ in the left arm and the second dose of MENVEO (lot# M10031) given IM in the left arm and desogestrel, APRI. It was reported that on 14-MAY-2012, the patient's face color turned pale, nonresponsive, her upper body stiffened and her right hand twitched. The registered nurse applied smelling salts to nasal area and the patient was responsive post-3 seconds. The face became flushed. Post 10 seconds the patient's face became pale, and the patient was again nonresponsive, her entire body stiffened and upper and lower body in seizure posturing position. It was applied smelling salts and the patient was responsive port 7 seconds. The face flushed once again. The patient stated "I do not know what happened but I think I just wet my pants". The patient lost urinary control during seizure and urinated on self. The patient was observed for 30 minutes. The registered nurse effected to contact family member but the patient declined. Once the patient was stable escorted the patient out of immunization room and the patient insistent on ambulating out of building by self. The patient again declined registered nurse repeated offer to contact emergency contact. On 14-MAY-2012 the patient went to emergency room and the patient had "several test" done per her primary physician's recommendations. Results came back normal. This report was considered non serious by the Agency. The original reporting source was not provided. The VAERS ID# is 455606-1. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old male patient with a medical history of faints at sight of needles in the past was vaccinated with a dose 1 of GARDASIL (lot # 672547/1745AA), Left arm, IM on 15-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 15-JUN-2012 at 13:45 within 2 minutes after GARDASIL was administered the patient's mom came out of exam room to report that her son fainted, it was described that the patient fainted on the floor and was assisted to exam table, Vital signals were taken by staff and reported to pediatrician. It was mentioned that the patient left alert in a good condition. No treatment information was reported. This report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID# is 457527-1. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Fall, Syncope
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old male patient with a medical history of faints at sight of needles in the past was vaccinated with a dose 1 of GARDASIL (lot # 672547/1745AA), Left arm, IM on 15-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 15-JUN-2012 at 13:45 within 2 minutes after GARDASIL was administered the patient's mom came out of exam room to report that her son fainted, it was described that the patient fainted on the floor and was assisted to exam table, Vital signals were taken by staff and reported to pediatrician. It was mentioned that the patient left alert in a good condition. No treatment information was reported. This report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID# is 457527-1. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL, DTAPIPV, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: This case was reported by a physician, via a sales representative, and described the occurrence of injection site cellulitis of the left thigh in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), varicella virus vaccine (non-gsk). On 10 July 2012 the subject received a dose of KINRIX (unknown, left thigh), 2nd dose of Varicella virus vaccine (Non-GSK) (unknown) and experienced vaccine administered at inappropriate site with KINRIX. The preferred site of administration for KINRIX is the deltoid muscle of the upper arm. On 10 July 2012, 2 days after vaccination with KINRIX and Varicella virus vaccine (Non-GSK), the subject experienced injection site cellulitis of the left thigh. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. The physician considered the events were probably related to vaccination with KINRIX and Varicella virus vaccine (Non-GSK). The physician reported another case with KINRIX via a sales representative. See A0990325A for details on the other case. The vaccine was received through vaccines for children. According to the sales representative, the physician had already reported both cases to VAERS.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL, DTAPIPV, VARCEL
Symptoms: Drug administered at inappropriate site, Hypersensitivity, Injection site cellulitis
Clinical narrative: This case was reported by a physician, via a sales representative, and described the occurrence of injection site cellulitis of the left thigh in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), varicella virus vaccine (non-gsk). On 10 July 2012 the subject received a dose of KINRIX (unknown, left thigh), 2nd dose of Varicella virus vaccine (Non-GSK) (unknown) and experienced vaccine administered at inappropriate site with KINRIX. The preferred site of administration for KINRIX is the deltoid muscle of the upper arm. On 10 July 2012, 2 days after vaccination with KINRIX and Varicella virus vaccine (Non-GSK), the subject experienced injection site cellulitis of the left thigh. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. The physician considered the events were probably related to vaccination with KINRIX and Varicella virus vaccine (Non-GSK). The physician reported another case with KINRIX via a sales representative. See A0990325A for details on the other case. The vaccine was received through vaccines for children. According to the sales representative, the physician had already reported both cases to VAERS.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, VARCEL, DTAPIPV, VARCEL
Symptoms: Drug administered at inappropriate site, Injection site cellulitis
Clinical narrative: This case was reported by a physician, via a sales representative, and described the occurrence of injection site cellulitis of the left thigh in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), varicella virus vaccine (non-gsk). On 10 July 2012 the subject received a dose of KINRIX (unknown, left thigh), 2nd dose of Varicella virus vaccine (Non-GSK) (unknown) and experienced vaccine administered at inappropriate site with KINRIX. The preferred site of administration for KINRIX is the deltoid muscle of the upper arm. On 10 July 2012, 2 days after vaccination with KINRIX and Varicella virus vaccine (Non-GSK), the subject experienced injection site cellulitis of the left thigh. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. The physician considered the events were probably related to vaccination with KINRIX and Varicella virus vaccine (Non-GSK). The physician reported another case with KINRIX via a sales representative. See A0990325A for details on the other case. The vaccine was received through vaccines for children. According to the sales representative, the physician had already reported both cases to VAERS.
Age: 0.16
Sex: M
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: C-reactive protein increased, Echocardiogram abnormal, Kawasaki's disease
Clinical narrative: Case was received from the Health Authorities on 08-Aug-2012 (reference number PEI2012025507). Case is medically confirmed. An 3-months-old male patient (weight: 7 kg; height: 62 cm) received a dose of ROTATEQ (lot-no. 0300AA), a dose of INFANRIX HEXA (GSK, lot-no. AR1CB158A) and a dose of PREVENAR 13 (Pfizer, lot-no. F40144) on 24-Jan-2012. Seven weeks later, on 13-Mar-2012, he developed an atypical Kawasaki's disease leading to hospitalisation for an unspecified time. No details were reported. On 18-Mar-2012 CRP was 17.4 mg/dl (no reference values reported) and echocardiography showed borderline width of left coronary artery. During the further course findings normalised. The patient was treated unsuccessfully with antibiotics. He then received IV PRIVIGEN and acetylsalicylic acid. He completely recovered after 13 days. According to the reporter, the reaction was considered to be life threatening and related to all vaccines.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Anaemia, C-reactive protein increased, Coronary artery dilatation, Echocardiogram abnormal, Electrocardiogram normal
Clinical narrative: High fever developed (103 degrees F), with extreme fussiness and irritability; this continued for 5 days, then a rash developed on his torso. Fever continued, other symptoms indicative of Kawasaki Disease appeared. Diagnosed with Kawasaki's Disease. He was admitted to the hospital and received IVIG and high dose ASA. Hospitalization lasted 3 days. We are following up with echocardiogram's which showed an ectasia of the left coronary artery.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Immunoglobulin therapy, Irritability, Kawasaki's disease, Platelet count increased, Pyrexia
Clinical narrative: High fever developed (103 degrees F), with extreme fussiness and irritability; this continued for 5 days, then a rash developed on his torso. Fever continued, other symptoms indicative of Kawasaki Disease appeared. Diagnosed with Kawasaki's Disease. He was admitted to the hospital and received IVIG and high dose ASA. Hospitalization lasted 3 days. We are following up with echocardiogram's which showed an ectasia of the left coronary artery.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Rash, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: High fever developed (103 degrees F), with extreme fussiness and irritability; this continued for 5 days, then a rash developed on his torso. Fever continued, other symptoms indicative of Kawasaki Disease appeared. Diagnosed with Kawasaki's Disease. He was admitted to the hospital and received IVIG and high dose ASA. Hospitalization lasted 3 days. We are following up with echocardiogram's which showed an ectasia of the left coronary artery.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Patient says rash developed about 20 minutes after immunizations were given. Hives to face, back, trunk, arms, upper thigh. No respiratory distress. Oral BENADRYL was given and rash faded after 20-30 minutes. (record attached)
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Barium enema abnormal, Enema administration, Haematochezia, Intussusception, Vomiting
Clinical narrative: Intussusception diagnosed at hospital 8/12/12. Reduced by barium enema at hospital. S/p vomiting & bloody stools.
Age: 37.0
Sex: F
Vaccine: HEPAB
Symptoms: Throat tightness
Clinical narrative: The patient walked in to the office today 10 minutes after receiving TWINRIX vaccine here as ordered. She c/o throat tightness. NO wheezing, coughing, or sob. No hx of adverse vaccine reactions in the past. She did start the VIVOTIF Rx last night, tolerated that well.
Age: 1.35
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Haemolytic uraemic syndrome, Pneumococcal infection, Pneumonia streptococcal
Clinical narrative: This is a spontaneous report from a contactable consumer and contactable nurse. A 2 years old male patient received a dose of PREVNAR 13 (Lot # E57642, Expiration date: 11/2011) at 0.5 ml single dose at 3 month on 26Jul2010 (Lot n. E57642, exp. Date Nov2011), at 5 months on 29Sep2010 (Lot n. E80082, exp. Date Dec2011), at 7 months on 22Nov2010 (Lot n. E82385, exp. Date 23Aug2011) and at 16 months on 23Aug2011 (Lot n. E70195, exp. Date 31Jul2012), intramuscularly. The patient also received HIB vaccine on 26Jul2010 (Lot n. UH045AB, exp. Date 09Jun2012), on 29Sep2010 (Lot n. UH158AA, exp. Date Sep2012), on 22Nov2010 (Lot n. UH166AA, exp. Date Oct2012) and on 23Aug2011 (Lot n. UH318AA, exp. Date Mar2013), intramuscularly. The patient had no known drug allergies. Relevant medical history and concomitant medications were not reported. On 10May2012 the patient had a severe pneumococcal infection and was hospitalized. The nurse stated that patient was seen in ER (Emergency Room) on 10May2012 then was seen in Primary Care Office on 15May2012 and 16May2012 and sent directly to hospital with subsequent transfer to another hospital. Patient was diagnosed with Streptococcal Pneumonia related Hemolytic Uremic Syndrome and was admitted on 17May2012 and discharged on 26May2012. At the time of this report, therapeutic measure taken in response to the event was unknown. The patient was recovered from the event. Follow-up attempts completed. No further information expected. Follow-up (26Jun2012): New information received from a female Nurse includes: lot # confirmation. Follow-up (16Aug2012): New information received includes patient's demographic, vaccinations and events details. Hemolytic Uremic Syndrome was added as adverse event.
Age: 1.02
Sex: F
Vaccine: PNC13
Symptoms: Vomiting projectile
Clinical narrative: 8-20-12 PM projectile vomiting, "few times".
Sex: U
Vaccine: H5N1
Symptoms: CSF protein increased, Electromyogram normal, Guillain-Barre syndrome, Immunoglobulin therapy, Miller Fisher syndrome
Clinical narrative: Initial report was received on 13 August 2012 via a search of the scientific literature. The following is verbatim per the literature citation: "Introduction: Guillain-Barre syndrome (GBS) is the most feared consequence of influenza vaccination. GBS was reported with the swine influenza vaccine in 1976, affecting approximately 1/100,000 (5-10 times the prevalence rate). Objective: During the fall of 2010, the authors saw four patients who developed GBS as a consequence of swine influenza vaccination. Methods/Results: The patients received vaccination between 10 and 30 days before onset of the first symptom. Two patients had predominantly sensory ataxia, areflexia, extremity and oropharyngeal numbness and paresthesia, and extremity pain. One patient had typical Miller-Fisher variant of GBS and the other developed perianal, groin, and limb numbness; oropharyngeal paresthesias; bowel incontinence; and urinary retention. The latter patient rapidly progressed into quadriparesis, right facial palsy, and areflexia. All patients had elevated cerebrospinal fluid protein. Three patients had sural sparing on nerve conduction studies, and one had absent F waves with abundant A waves; the patient with Miller-Fisher syndrome had normal needle electromyography. All patients were treated with intravenous immunoglobulin (IVIg). Three had excellent recovery within a few months; however, the patient who relapsed had an evidence of axonal loss in the legs, needed a repeat 5-day course of IVIg, and had a slow improvement. Conclusion: GBS may follow the contemporary swine influenza vaccination and may manifest atypically with predominant ataxia, sphincteric disturbance, or Miller-Fisher syndrome. Studies with larger cohorts are necessary to determine the incidence of this consequence of influenza vaccine." Documents held by sender: none.
Age: 1.34
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 14 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a four-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had previously received 4 doses of DAPTACEL; lot number C2657AA received on 06 September 2007, C2749BA received on 06 November 2007, C2760AA received on 04 January 2008 and C2955BA received on 03 November 2008 (routes and sites of administration not reported). The subject developed a cough on 01 July 2012, approximately three years and 8 months after the last dose. On 02 July 2012, he developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 01 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 02 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 17 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.34
Sex: M
Vaccine: DTAP
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 14 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a four-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had previously received 4 doses of DAPTACEL; lot number C2657AA received on 06 September 2007, C2749BA received on 06 November 2007, C2760AA received on 04 January 2008 and C2955BA received on 03 November 2008 (routes and sites of administration not reported). The subject developed a cough on 01 July 2012, approximately three years and 8 months after the last dose. On 02 July 2012, he developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 01 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 02 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 17 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.34
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 14 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a four-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received a dose of DAPTACEL; lot number C2934BA received on 27 June 2008, 2 doses of PENTACEL; lot number C3176AA received on 25 August 2008 and lot number C3227AA received on 20 January 2009, and a dose of DAPTACEL; lot number C3084AA received on 25 August 2009 (routes and sites of administration not reported). The subject developed a paroxysmal cough with a whoop on 06 July 2012, approximately three years after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 12 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 12 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 03 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: 1.34
Sex: M
Vaccine: DTAP
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 14 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a four-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received a dose of DAPTACEL; lot number C2934BA received on 27 June 2008, 2 doses of PENTACEL; lot number C3176AA received on 25 August 2008 and lot number C3227AA received on 20 January 2009, and a dose of DAPTACEL; lot number C3084AA received on 25 August 2009 (routes and sites of administration not reported). The subject developed a paroxysmal cough with a whoop on 06 July 2012, approximately three years after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 12 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 12 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 03 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: 0.64
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 14 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; received on 03 November 2011, 12 January 2012 and 13 February 2012 (lot numbers, routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 19 July 2012, approximately 5 months after the last dose. On 23 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 25 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 09 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.64
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 14 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; received on 03 November 2011, 12 January 2012 and 13 February 2012 (lot numbers, routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 19 July 2012, approximately 5 months after the last dose. On 23 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 25 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 09 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 14 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 14-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3783AA received on 21 July 2011, C3912AA received on 22 September 2011 and C3818AA received on 22 November 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 21 July 2012, approximately 8 months after the last dose. On 23 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 24 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 24 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 14 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 14-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3783AA received on 21 July 2011, C3912AA received on 22 September 2011 and C3818AA received on 22 November 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 21 July 2012, approximately 8 months after the last dose. On 23 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 24 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 24 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Hypokinesia, Insomnia, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Initial report was received 15 August 2012 from a consumer via the manufacturer's company sponsored website. A patient (gender, age and date of birth not reported) had received FLUZONE, lot number UT433AA on 20 October 2011. The day after vaccination, the patient began to experience increasing pain in the left shoulder and was unable to move their arm by that evening. They presented to the emergency room due to the pain and had an x-ray was performed (results not reported). The patient was prescribed unspecified pain killers and was advised to see Orthopedics. The patient had an orthopedic visit "a couple of days" after their orthopedic visit. A MRI was ordered and showed "adhesive capsulitis etc.". The patient performed intense exercise for a couple of weeks with little relief, and could not sleep many nights due to intense pain. After many months of home therapy, the patient continued to have pain on certain movements and during the night. Outcome was not recovered. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Periarthritis, X-ray limb
Clinical narrative: Initial report was received 15 August 2012 from a consumer via the manufacturer's company sponsored website. A patient (gender, age and date of birth not reported) had received FLUZONE, lot number UT433AA on 20 October 2011. The day after vaccination, the patient began to experience increasing pain in the left shoulder and was unable to move their arm by that evening. They presented to the emergency room due to the pain and had an x-ray was performed (results not reported). The patient was prescribed unspecified pain killers and was advised to see Orthopedics. The patient had an orthopedic visit "a couple of days" after their orthopedic visit. A MRI was ordered and showed "adhesive capsulitis etc.". The patient performed intense exercise for a couple of weeks with little relief, and could not sleep many nights due to intense pain. After many months of home therapy, the patient continued to have pain on certain movements and during the night. Outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Diarrhoea, Hypersensitivity, Lip swelling, Oedema peripheral
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 16 August 2012. A female patient (age and date of birth not reported) had received a dose of INFLUENZA VACCINE with PANDEMIC INFLUENZA VACCINE (manufacturer, lot number, route, site and exact date of administration not reported) in October of 2010. The next day, the patient had an allergic reaction. She got sick to her stomach, lips, throat and hands swelled up and she got severe diarrhea for days. The patient had influenza vaccines for years with no problems and was not allergic to eggs. The patient's outcome was not reported. The patient also experienced another adverse event which was captured in case number 2012-07679. Documents held by sender: None.
Sex: F
Vaccine: FLUX
Symptoms: Pharyngeal oedema
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 16 August 2012. A female patient (age and date of birth not reported) had received a dose of INFLUENZA VACCINE with PANDEMIC INFLUENZA VACCINE (manufacturer, lot number, route, site and exact date of administration not reported) in October of 2010. The next day, the patient had an allergic reaction. She got sick to her stomach, lips, throat and hands swelled up and she got severe diarrhea for days. The patient had influenza vaccines for years with no problems and was not allergic to eggs. The patient's outcome was not reported. The patient also experienced another adverse event which was captured in case number 2012-07679. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Diarrhoea, Feeling abnormal, Food intolerance, Hypersensitivity
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 16 August 2012. A female patient (age and date of birth not reported) had received a dose of FLUZONE, Sanofi Pasteur Inc, lot number UH455AC on 30 September 2011. A day and a half later, the patient had the same allergic reaction she experienced after a previous influenza vaccine with pandemic influenza except it was twice as bad. She thought she was going to die. At the time of the report, the patient could not eat certain foods due to a delicate stomach. The patient experienced an allergic reaction where she got sick to her stomach, lips, throat and hands swelled up and she got severe diarrhea from an Influenza vaccine with Pandemic Influenza vaccine in October of 2010. This reaction was captured in case number 2012-07678. The patient received influenza vaccines for years prior to this reaction with no problem and was not allergic to eggs. The patient's outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Oedema peripheral, Pharyngeal oedema, Similar reaction on previous exposure to drug
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 16 August 2012. A female patient (age and date of birth not reported) had received a dose of FLUZONE, Sanofi Pasteur Inc, lot number UH455AC on 30 September 2011. A day and a half later, the patient had the same allergic reaction she experienced after a previous influenza vaccine with pandemic influenza except it was twice as bad. She thought she was going to die. At the time of the report, the patient could not eat certain foods due to a delicate stomach. The patient experienced an allergic reaction where she got sick to her stomach, lips, throat and hands swelled up and she got severe diarrhea from an Influenza vaccine with Pandemic Influenza vaccine in October of 2010. This reaction was captured in case number 2012-07678. The patient received influenza vaccines for years prior to this reaction with no problem and was not allergic to eggs. The patient's outcome was not recovered. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Sensory disturbance
Clinical narrative: I received my Vaccinations of ZOSTAVAX on 10/06/2012. Lot #H009779 expDte 23 MAR 2013. On Monday 10/07/2012 I experienced a sensation on my right arm above the biflex...the vaccination was given in my left arm. By Tuesday 10/08/2012 I had a number of blisters forming on my right arm like a Herpes Virus blister. On Wednesday I called the pharmacy and asked if I could take the medication for Herpes and they said not for 14 days after the vaccination. By Saturday a large area on my upper arm was covered with painful blisters. On Monday I attended the physician who prescribed the vaccination and she said she had never seen this kind of reaction to the ZOSTAVAX and stated that it looked as though it was spreading more and could possibly got infected so she had put me on antibiotics and pain medication. I have a location on my leg that breaks out in Herpes if I get too much exposure to the Sun and I know how to treat it...none of this treatment antibiotic salve and bandages works on this outbreak on my arm.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Glioma, Rash maculo-papular, Urticaria
Clinical narrative: The patient is a 5 year old male with a recurrent desmoplastic infantile ganglioglioma who began treatment on study to evaluate the effects of vaccinations with HLA-A2-restricted glioma antigen-peptides in combinations with Poly-ICLCfl on 7/16/2012. The patient developed a macula-papular rash on his legs within 4 days of receiving his first set of injections on 7/16/12, which waxed and waned. The day after he received his 2nd vaccine on 8/9/2012, he developed widespread urticaria -grade 2-. He was seen at the emergency department of hospital on 8/10/2012 where he was treated with po BENADRYL and ZYRTEC. He was sent home on BENADRYL and ZYRTEC and the hives resolved over the next few days.
Age: 29.0
Sex: M
Vaccine: TYP
Symptoms: Fall, Grunting, Loss of consciousness, Malaise, Musculoskeletal stiffness
Clinical narrative: Patient recieved PPD placement ansd then received typhoid in left arm. Patient then stated he didn't feel well and went unconscious.  Patient fell back on an exam table and sustained zero injuries.  Patient began to grunt and became very tense.  Overhead Code Blue was initiated.  0.3ml Epi Auto Injector was administered Immediately into Left medial lateral thigh and held in place for 10 seconds.  Patient woke up 10-15 seconds after auto injector was given.  Patient stated he did not remember anything.  Patient was placed on NRB at 15lpm.  Initial vitals where taken and recorded.  Patient was assessed by Dr.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives on stomach, chest, back, not itchy. Smaller than penny. No SOB, no tongue numbness or swelling. No other symptoms. Advised to take antihistamine, go to ER if any SOB, tongue swelling.
Age: 19.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dyskinesia, Fall, Hyperhidrosis, Hypotonia, Loss of consciousness
Clinical narrative: Patient was seated to receive vaccines: Varicella, Tdap (left arm) & Menactra (right arm), in that sequence.  Within seconds of the last injection, patient lost consciousness. Symptoms included: pale diaphoretic skin, gurgling sound, head extension, limp body, several jerking movements of head and arms, slump to the right, and slow fall to the floor in face down position. He continued breathing though was unresponsive to loud voice or touch. Duration of loss of consciousness was approx. 60 secs. He regained consciousness spontaneously and was immediately alert and oriented x3. Vitals during LOC: 134/78, P 60, R 14. Vitals at 2:55 pm 124/82, P 68, R 12.
Age: 19.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pallor, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Patient was seated to receive vaccines: Varicella, Tdap (left arm) & Menactra (right arm), in that sequence.  Within seconds of the last injection, patient lost consciousness. Symptoms included: pale diaphoretic skin, gurgling sound, head extension, limp body, several jerking movements of head and arms, slump to the right, and slow fall to the floor in face down position. He continued breathing though was unresponsive to loud voice or touch. Duration of loss of consciousness was approx. 60 secs. He regained consciousness spontaneously and was immediately alert and oriented x3. Vitals during LOC: 134/78, P 60, R 14. Vitals at 2:55 pm 124/82, P 68, R 12.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV4, MEN
Symptoms: Dyskinesia, Musculoskeletal stiffness, Syncope
Clinical narrative: Fainted, went stiff, jerking movements.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: HOT, ITCHY, 2 INCHES IN DIAMETER, SWOLLEN. NO TREATMENT.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: CLIENT RECEIVED PEDIATRIC FORMULATION OF HEPATITIS B VACCINE INSTEAD OF ADULT.  ERROR NOTED ON QA AUDIT ON 8/22/12.  ADULT FORMULATION OF VACCINE ADMINSITERED ON 8/22/12 WITH EXPLANATION TO CLIENT.
Age: 22.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Local reaction, Oedema peripheral, Skin warm
Clinical narrative: Localized reaction to back of right arm 5cm by 4cm raised hot to touch and red.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash pustular
Clinical narrative: Generalized skin rash legs, arms, trunk with dried pustules and fine rash on trunk.
Age: 0.57
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: NO ADVERSE EVENT.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Visual impairment
Clinical narrative: Dizziness x 1 month, visual changes only for a few seconds, difficulty ambulating for few seconds.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site rash
Clinical narrative: Large rash at vaccination site about 4 inches in diameter. Other patient's receiving this lot also reported rashes.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Dizziness, Dyspnoea, Headache, Musculoskeletal stiffness
Clinical narrative: Patient reported on 8/21/12 that after receiving Tdap on 8/17/12 in (Lt) Deltoid pt reports on 8/18/12 had a fever of 102.9, headache body aches, nausea, dizziness, cough, sore throat, stiffness, and hard time breathing. Reports all symptoms went away within 48 hours after onset.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Patient reported on 8/21/12 that after receiving Tdap on 8/17/12 in (Lt) Deltoid pt reports on 8/18/12 had a fever of 102.9, headache body aches, nausea, dizziness, cough, sore throat, stiffness, and hard time breathing. Reports all symptoms went away within 48 hours after onset.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Oedema, Pain, Rash, Swelling
Clinical narrative: On 8/13/12 patient receive 2 vaccinations, GARDASIL in right deltoid at 4:30 pm. Increasing edema redness & pain developed 24 hours after. Returned to MD off 8/15/12 am. Size of swelling - 13 x 14 cms with redness/spots. Tx cool compresses and BENADRYL. Visit 8/17/12 - improved redness/edema now 7 x 8 cms.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Hot flush, Injection site erythema, Injection site induration, Swelling
Clinical narrative: ZOSTAVAX given (L) arm 8/3, swelling noted next day. By 8/8, noted "hot flashes" without fever.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Body temperature increased
Clinical narrative: Dad reported temperature of 103 degrees after vaccine administration.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Depression, Eating disorder
Clinical narrative: After the 3rd GARDASIL vaccination my daughter stopped getting her monthly menses. She had been regular up to that point. She is now suffering from depression and an eating disorder. Are there any other reported cases of girls/woman having the GARDASIL treatment and experiencing the same side effects?
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles - I took the shingles shot Nov. 19th 2008. Now I have a case of shingles extending from middle of back around the left side to the middle of my navel, now taking VALTREX or the generic Valacyclovir 1 gram and Hydrocodone for pain.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash pruritic, Rash vesicular, Viral titre increased
Clinical narrative: She broke out in a rash that appears as if to be chicken pox. Blistering and pruritic. This occurred despite verifying previous infection with a titer.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Blood test, Computerised tomogram, Headache, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: Patient initial began with a severe headache and neckache.  He then proceeded to have several days of severe fever and vomiting.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient initial began with a severe headache and neckache.  He then proceeded to have several days of severe fever and vomiting.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Patient describes "horrible shooting" pain down arm when moved. Vaccine administered 8-15-12 complaint 8-17-12.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash
Clinical narrative: Pt received ZOSTAVAX vaccine 2 hours after developed rash on both arms & a headache. Resolved w/i 1 day. No problems now.
Age: 27.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Chest discomfort, Dyspnoea, Nasal congestion, Pain
Clinical narrative: Aches, nasal congestion, feeling of heaviness on chest, difficult to take deep breaths.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Experienced syncopal episode approx. 5 minutes after receiving vaccines.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Head injury, Hyperhidrosis, Loss of consciousness
Clinical narrative: Client passed out at checkout window, fell backwards and bumped his head on a closed door, opened eyes when on floor and was covered in sweat, BP:80/60 P:96 regular. Legs where elevated and patient was monitored for 30 minutes. Followed up next morning by phone, and he stated that he was doing fine. No headache, bleeding or bruising.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Oedema peripheral
Clinical narrative: L arm started swelling around 7:30 08/21/12 a.m.  Swollen to the size of silver dollar.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Arm swelling and painful, continued to swell and pain increased throughout the night. Applied ice and took ibuprofen 800 mg. Minimal pain relief and minimal decrease in swelling the following day.
Age: 63.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Neck pain, Rash
Clinical narrative: Developed a sore neck and rash 12 days after administration of vaccine.
Age: 14.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Headache (1 week), Fever 102.5 (1.5 weeks), rash, nausea (5 weeks), dizziness (5 weeks), extreme fatigue (still experiencing at 7 weeks), swollen face.
Age: 14.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Swelling face
Clinical narrative: Headache (1 week), Fever 102.5 (1.5 weeks), rash, nausea (5 weeks), dizziness (5 weeks), extreme fatigue (still experiencing at 7 weeks), swollen face.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Pain, Pyrexia, Swelling, Vomiting
Clinical narrative: Fever and swelling and vomiting and body aches.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Tenderness erythema and swelling at the injection site.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV1
Symptoms: Urticaria
Clinical narrative: Hives- back, upper shoulder, chest.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Musculoskeletal pain, Musculoskeletal stiffness, Pain
Clinical narrative: Generalized pain and stiffness around the Left shoulder particularly with movement. Also chills, and shakes later that evening along with a tired feeling. Shoulder is still stiff and sore this AM though a hot shower temporarily eased both stiffness and pain with motion. That is coming back however. There is no longer a feverish/shaky feeling.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Generalized pain and stiffness around the Left shoulder particularly with movement. Also chills, and shakes later that evening along with a tired feeling. Shoulder is still stiff and sore this AM though a hot shower temporarily eased both stiffness and pain with motion. That is coming back however. There is no longer a feverish/shaky feeling.
Age: 33.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Itching, red, painful raised rash over the right upper arm just distal to IM injection site.
Age: 1.75
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Ataxia, CSF culture negative, CSF glucose decreased, CSF protein increased
Clinical narrative: Guillain-Barre syndrome-- pt developed weakness, ataxia, and difficulty walking.  Was treated with IVIG x 5 days.  Clinically improved prior to d/c from hospital on 08/22/2012.  Now receiving PT services as outpatient.
Age: 1.75
Sex: F
Vaccine: HEPA
Symptoms: Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillain-Barre syndrome-- pt developed weakness, ataxia, and difficulty walking.  Was treated with IVIG x 5 days.  Clinically improved prior to d/c from hospital on 08/22/2012.  Now receiving PT services as outpatient.
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Abdominal pain lower, Blood test abnormal, Dehydration, Drug intolerance, Gastroenteritis
Clinical narrative: Fever, malaise, nausea, vomiting and lower abdominal pain. Could not tolerate anti nausea / fever reducer medications. Returned to pediatrician on 08/18. Received IV fluids for dehydration on 08/19. Admitted to hospital on 08/20. Received IV fluids and blood tests showing inflammation of the liver. Released 08/22 at 2:00 PM with discharge diagnosis of acute gastroenteritis.
Age: 10.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Inflammation, Malaise, Nausea, Pyrexia, Urine analysis
Clinical narrative: Fever, malaise, nausea, vomiting and lower abdominal pain. Could not tolerate anti nausea / fever reducer medications. Returned to pediatrician on 08/18. Received IV fluids for dehydration on 08/19. Admitted to hospital on 08/20. Received IV fluids and blood tests showing inflammation of the liver. Released 08/22 at 2:00 PM with discharge diagnosis of acute gastroenteritis.