chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Red area about 3 inches long and 2 inches wide about 1/8 inch below injection site. Very itchy, hot, and painful.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chest discomfort, Dizziness, Heart rate increased, Throat tightness
Clinical narrative: First throat felt tight & heart sped up. Then felt dizzy & weak. Returned to clinic for evaluation, felt like passing out, dizzy again. Symptoms came and went - dizzy, weakness, tightness in chest. Went to ER for evaluation. No treatment. (All within 3 hours of vaccination).
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy bone marrow normal, Blood test abnormal, Condition aggravated, Haemoglobin decreased, Haemolytic anaemia
Clinical narrative: I was having advanced edema in my legs and went to the ER clinic in my neighborhood when it was determined my hemaglobin was 4.2 and I was taken to the ER where after 5 days was diagnosed with hemolytic anemia brought on by a foreign virus in my blood.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Viral infection, Viral test positive
Clinical narrative: I was having advanced edema in my legs and went to the ER clinic in my neighborhood when it was determined my hemaglobin was 4.2 and I was taken to the ER where after 5 days was diagnosed with hemolytic anemia brought on by a foreign virus in my blood.
Age: 57.0
Sex: M
Vaccine: ANTH
Symptoms: Administration site pain
Clinical narrative: Pain at the administered site.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Computerised tomogram, Decreased appetite, Diplegia, Headache, Hypoaesthesia
Clinical narrative: Initial report was received from a health care professional on 31 January 2012. An 18-year-old female patient had received an injection of MENACTRA, sanofi pasteur Inc. (lot number, site and route of administration not reported) on 03 December 2011. On 12 December 2011, the patient experienced severe headaches, tremors, paralysis to the lower extremities and was diagnosed by a physician to have transverse myelitis. The patient was hospitalized for 14 days and fully recovered. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Ileus paralytic, Laboratory test, Lumbar puncture, Neurogenic bladder, Nuclear magnetic resonance imaging
Clinical narrative: Initial report was received from a health care professional on 31 January 2012. An 18-year-old female patient had received an injection of MENACTRA, sanofi pasteur Inc. (lot number, site and route of administration not reported) on 03 December 2011. On 12 December 2011, the patient experienced severe headaches, tremors, paralysis to the lower extremities and was diagnosed by a physician to have transverse myelitis. The patient was hospitalized for 14 days and fully recovered. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Paralysis, Pyrexia, Tremor, Urine analysis, X-ray
Clinical narrative: Initial report was received from a health care professional on 31 January 2012. An 18-year-old female patient had received an injection of MENACTRA, sanofi pasteur Inc. (lot number, site and route of administration not reported) on 03 December 2011. On 12 December 2011, the patient experienced severe headaches, tremors, paralysis to the lower extremities and was diagnosed by a physician to have transverse myelitis. The patient was hospitalized for 14 days and fully recovered. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Diplegia, Headache, Myelitis transverse, Tremor
Clinical narrative: Initial report was received from a health care professional on 31 January 2012. An 18-year-old female patient had received an injection of MENACTRA, sanofi pasteur Inc. (lot number, site and route of administration not reported) on 03 December 2011. On 12 December 2011, the patient experienced severe headaches, tremors, paralysis to the lower extremities and was diagnosed by a physician to have transverse myelitis. The patient was hospitalized for 14 days and fully recovered. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Bone pain, Erythema, Skin hypertrophy
Clinical narrative: Information has been received from a 68 year old male reporting on himself, with no drug reactions/allergies, who on 05-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck), subdermally (dose not reported) (lot # reported as "01404" is not valid for ZOSTAVAX (Merck). Concomitant therapy included levothyroxine Na, omeprazole, CRESTOR, metformin, lisinopril-HCTZ (manufacturer unknown), carvedilol and "Clomazean". The patient reported that on 05-OCT-2011 he had back fused. The patient also reported that on 18-JAN-2012 he started with pain in back, then developed bumps on back and right side (blisters), his physician diagnosed as shingles. Following treatment was prescribed for an AE: acyclovir, "gabaedentin", citalopram. At the time of the report the patient's outcome was unknown. On 24-JAN-2012 the patient had colonoscopy and gastroscopy performed. Upon internal review, spinal fusion surgery was considered to be an other important medical event. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back disorder, Back pain, Blister, Colonoscopy, Endoscopy upper gastrointestinal tract
Clinical narrative: Information has been received from a 68 year old male reporting on himself, with no drug reactions/allergies, who on 05-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck), subdermally (dose not reported) (lot # reported as "01404" is not valid for ZOSTAVAX (Merck). Concomitant therapy included levothyroxine Na, omeprazole, CRESTOR, metformin, lisinopril-HCTZ (manufacturer unknown), carvedilol and "Clomazean". The patient reported that on 05-OCT-2011 he had back fused. The patient also reported that on 18-JAN-2012 he started with pain in back, then developed bumps on back and right side (blisters), his physician diagnosed as shingles. Following treatment was prescribed for an AE: acyclovir, "gabaedentin", citalopram. At the time of the report the patient's outcome was unknown. On 24-JAN-2012 the patient had colonoscopy and gastroscopy performed. Upon internal review, spinal fusion surgery was considered to be an other important medical event. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Spinal fusion surgery
Clinical narrative: Information has been received from a 68 year old male reporting on himself, with no drug reactions/allergies, who on 05-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck), subdermally (dose not reported) (lot # reported as "01404" is not valid for ZOSTAVAX (Merck). Concomitant therapy included levothyroxine Na, omeprazole, CRESTOR, metformin, lisinopril-HCTZ (manufacturer unknown), carvedilol and "Clomazean". The patient reported that on 05-OCT-2011 he had back fused. The patient also reported that on 18-JAN-2012 he started with pain in back, then developed bumps on back and right side (blisters), his physician diagnosed as shingles. Following treatment was prescribed for an AE: acyclovir, "gabaedentin", citalopram. At the time of the report the patient's outcome was unknown. On 24-JAN-2012 the patient had colonoscopy and gastroscopy performed. Upon internal review, spinal fusion surgery was considered to be an other important medical event. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: FLUX, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: C-reactive protein increased, Culture urine negative, Eye infection, Liver function test normal, Pharyngitis
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 02-Feb-2012) concerns a 5-year-old female patient. At the time of vaccination (prior to administration) the patient complained of dysuria and was found to have hematuria on UA (urinalysis). The patient was given cephalexin on the same day for presumptive UTI (urinary tract infection). Urine culture was negative and cephalexin was discontinued after 4 days. On 24-Jan-2012 the patient received INFLUENZA vaccine. Concomitant vaccines included MMR and VARIVAX. The patient then developed a fever (about 5 days after vaccination) and a red maculopapular rash (about 7 days after vaccination). The patient also had exudative pharyngitis and palpebral conjunctival 'injection'. On 01-Feb-2012 the patient was hospitalised. Renal ultrasound, liver and renal function tests were normal. The patient had elevated CRP and ESR (erythrocyte sedimentation rate). The patient remained hospitalised as of 02-Feb-2012. W/U (work-up) was pending.
Age: 5.0
Sex: F
Vaccine: FLUX, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash maculo-papular, Red blood cell sedimentation rate increased, Renal function test normal
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 02-Feb-2012) concerns a 5-year-old female patient. At the time of vaccination (prior to administration) the patient complained of dysuria and was found to have hematuria on UA (urinalysis). The patient was given cephalexin on the same day for presumptive UTI (urinary tract infection). Urine culture was negative and cephalexin was discontinued after 4 days. On 24-Jan-2012 the patient received INFLUENZA vaccine. Concomitant vaccines included MMR and VARIVAX. The patient then developed a fever (about 5 days after vaccination) and a red maculopapular rash (about 7 days after vaccination). The patient also had exudative pharyngitis and palpebral conjunctival 'injection'. On 01-Feb-2012 the patient was hospitalised. Renal ultrasound, liver and renal function tests were normal. The patient had elevated CRP and ESR (erythrocyte sedimentation rate). The patient remained hospitalised as of 02-Feb-2012. W/U (work-up) was pending.
Age: 5.0
Sex: F
Vaccine: FLUX, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: Ultrasound kidney normal
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 02-Feb-2012) concerns a 5-year-old female patient. At the time of vaccination (prior to administration) the patient complained of dysuria and was found to have hematuria on UA (urinalysis). The patient was given cephalexin on the same day for presumptive UTI (urinary tract infection). Urine culture was negative and cephalexin was discontinued after 4 days. On 24-Jan-2012 the patient received INFLUENZA vaccine. Concomitant vaccines included MMR and VARIVAX. The patient then developed a fever (about 5 days after vaccination) and a red maculopapular rash (about 7 days after vaccination). The patient also had exudative pharyngitis and palpebral conjunctival 'injection'. On 01-Feb-2012 the patient was hospitalised. Renal ultrasound, liver and renal function tests were normal. The patient had elevated CRP and ESR (erythrocyte sedimentation rate). The patient remained hospitalised as of 02-Feb-2012. W/U (work-up) was pending.
Age: 5.0
Sex: F
Vaccine: FLUX, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: C-reactive protein increased, Conjunctivitis infective, Culture urine negative, Liver function test normal, Pharyngitis
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 02-Feb-2012) concerns a 5-year-old female patient. At the time of vaccination (prior to administration) the patient complained of dysuria and was found to have hematuria on UA (urinalysis). The patient was given cephalexin on the same day for presumptive UTI (urinary tract infection). Urine culture was negative and cephalexin was discontinued after 4 days. On 24-Jan-2012 the patient received INFLUENZA vaccine. Concomitant vaccines included MMR and VARIVAX. The patient then developed a fever (about 5 days after vaccination) and a red maculopapular rash (about 7 days after vaccination). The patient also had exudative pharyngitis and palpebral conjunctival 'injection'. On 01-Feb-2012 the patient was hospitalised. Renal ultrasound, liver and renal function tests were normal. The patient had elevated CRP and ESR (erythrocyte sedimentation rate). The patient remained hospitalised as of 02-Feb-2012. W/U (work-up) was pending.
Age: 5.0
Sex: F
Vaccine: FLUX, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: Ultrasound kidney normal, Urine analysis abnormal
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 02-Feb-2012) concerns a 5-year-old female patient. At the time of vaccination (prior to administration) the patient complained of dysuria and was found to have hematuria on UA (urinalysis). The patient was given cephalexin on the same day for presumptive UTI (urinary tract infection). Urine culture was negative and cephalexin was discontinued after 4 days. On 24-Jan-2012 the patient received INFLUENZA vaccine. Concomitant vaccines included MMR and VARIVAX. The patient then developed a fever (about 5 days after vaccination) and a red maculopapular rash (about 7 days after vaccination). The patient also had exudative pharyngitis and palpebral conjunctival 'injection'. On 01-Feb-2012 the patient was hospitalised. Renal ultrasound, liver and renal function tests were normal. The patient had elevated CRP and ESR (erythrocyte sedimentation rate). The patient remained hospitalised as of 02-Feb-2012. W/U (work-up) was pending.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Activities of daily living impaired, Asthenia, Blood test, Hypersomnia, Injection site erythema
Clinical narrative: This medically confirmed spontaneous report (initially received on 31-Jan-2012) concerns a 14 year old male patient with a medical history of a penicillin allergy. On 22-Dec-2011, at night, the patient received a flu shot. On the same day, the patient received co-suspect drug GARDASIL vaccine by injection. The indication was 'HPV vaccine'. Approximately 1 week after the injection, the patient developed asthenia and a red spot at the injection site. The patient had missed a month of school because of the reaction. The nurse reported that the patient was still having difficulties. He was sleeping up to 20 hours a day. The patient only had 1 dose of GARDASIL. The patient was not given any treatment for the events. Blood tests were performed. The event outcome was not recovered. Follow-up (03-Feb-2012): case was upgraded to serious, case was medically confirmed by a nurse, event summary description.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Per mother, pt. developed hives all over 1 hour after vaccination. No fever, no SOB, no vomiting. Pt. was seen at clinic and was given BENADRYL. Rashes resolved after 3 days.
Age: 1.37
Sex: F
Vaccine: DTAP, FLU3, PNC13, VARCEL
Symptoms: Balance disorder, Dyspnoea, Gaze palsy, Hypopnoea, Hypotonia
Clinical narrative: Reported event took place approximately 45 minutes after child received four immunizations.  Child received DTaP, Varicella, Prevnar, and Fluzone.  MOP had taken child home and was feeding her lunch in her high chair.  MOP states child's eyes rolled back, she became stiff and then her head fell forward. MOP removed her from the high chair and stated that the child was completely limp and respirations were shallow.  MOP states that child was probably unconscious for 30 seconds and then gasped for air and became conscious again. MOP also stated that the child was lethargic immediately after regaining consciousness.  The child then wanted to be put down so MOP let her down and she stated that the child was unsteady on her feet but after a few minutes she was completely back to normal.
Age: 1.37
Sex: F
Vaccine: DTAP, FLU3, PNC13, VARCEL
Symptoms: Lethargy, Loss of consciousness, Musculoskeletal stiffness, Posture abnormal
Clinical narrative: Reported event took place approximately 45 minutes after child received four immunizations.  Child received DTaP, Varicella, Prevnar, and Fluzone.  MOP had taken child home and was feeding her lunch in her high chair.  MOP states child's eyes rolled back, she became stiff and then her head fell forward. MOP removed her from the high chair and stated that the child was completely limp and respirations were shallow.  MOP states that child was probably unconscious for 30 seconds and then gasped for air and became conscious again. MOP also stated that the child was lethargic immediately after regaining consciousness.  The child then wanted to be put down so MOP let her down and she stated that the child was unsteady on her feet but after a few minutes she was completely back to normal.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: PREVNAR 13 given when should have been IPOL. Client still in clinic when error realized. IPOL given. Client left with parent in no distress. No reactions reported.
Age: 1.18
Sex: F
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Borrelia test negative, Red blood cell sedimentation rate normal, VIth nerve paralysis
Clinical narrative: Possible adverse events from receiving the vaccines: INFLUENZA, MMR, varicella and PREVNAR 13. Pt. developed 6th optic nerve palsy affecting (L) eye. Pt. received the above vaccines on 12-9-11.
Age: 0.74
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever (low grade fever) 8-9 hours after receiving vaccines on 1-31-12.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Joint range of motion decreased, Pain of skin, Skin warm
Clinical narrative: One day after injection noted to have 5 cm area of warm, red very tender area at upper deltoid along with 2 large finger like red streaks extending into left axillae. ROM limited to 70 degree extension. Tender to palpation. Treated with prednisone x 14 days.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Injection site erythema, Injection site swelling, Screaming
Clinical narrative: (R) thigh (PENTACEL) very swollen, red knee to thigh. Child screaming inconsolably w/ acetaminophen. Advised cool compress and visit to ER due to reaction at child's age.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Epistaxis, Headache, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Received Tdap 1-31-12 (Tues.) Called employee health 2-2-12 (Thurs.) complained of fever, headache, muscle aches. Swelling & pain at injection site. Nose bleed. Nausea.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Received Tdap 1-31-12 (Tues.) Called employee health 2-2-12 (Thurs.) complained of fever, headache, muscle aches. Swelling & pain at injection site. Nose bleed. Nausea.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood culture negative, Full blood count normal, Pyrexia
Clinical narrative: 6 days with fever.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Feeling of body temperature change, Injection site cellulitis, Injection site inflammation, Injection site scab
Clinical narrative: Inflammatory reaction at site of vaccine treated as cellulitis. Small scab remained until physically dislodged in office. Pt is left with some temperature sensation changes in that arm & likely a scar similar to smallpox.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Heart rate increased, Nausea, Rash, Urticaria
Clinical narrative: Hives - anterior chest/neck - 3 hrs after rcving INFLUENZA vaccine nausea & vomiting; Elevated HR slightly swollen eyes. Rash resolved within 2 hrs. No treatment.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Hives - anterior chest/neck - 3 hrs after rcving INFLUENZA vaccine nausea & vomiting; Elevated HR slightly swollen eyes. Rash resolved within 2 hrs. No treatment.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Seen 2/3/12 for headache & delayed immunizations. Received flu vaccine ((L) upper arm), HPV vaccine ((R) upper arm superior aspect) & varicella vaccine ((R) upper middle area). Within 10 - 20 minutes felt itching by varicella vaccine & swelling. Swelling has slightly decreased & itchiness has decreased. Area is not painful except for with palpation. Has not used any meds except for topical hydrocortisone, slightly helpful.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt received an HPV #2. Pt got dizzy & passed out. Was laid down then woke up. Pt was seen and eval by provider and sent home.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Vaccination complication
Clinical narrative: 1 cm x 2 cm vaccine reaction.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Joint range of motion decreased, Skin warm, Swelling
Clinical narrative: Pt developed redness with mild swelling & hot to touch with decrease range of motion secondary to immunization. Pt given KEFLEX 250mg per tsp. 1 tsp QID x 7 days.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Blood test abnormal, Contusion, Diarrhoea, Nausea, Platelet count decreased
Clinical narrative: Mother called today 2-6-12 states son had shots flu & hep A on 1-25-12. Next day had nausea/vomiting diarrhea over last week has rash on neck, chest & back bruises on shins, knees top of feet elbows & hands appt made with clinic to see dr today.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Rash, Vomiting
Clinical narrative: Mother called today 2-6-12 states son had shots flu & hep A on 1-25-12. Next day had nausea/vomiting diarrhea over last week has rash on neck, chest & back bruises on shins, knees top of feet elbows & hands appt made with clinic to see dr today.
Age: 16.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: Dr ordered varicella & pt was given ZOSTAVAX in error. Pt experienced swelling & redness at injection site per mother on 2/1/12. Pt's reaction is resolved and he will follow up as needed. Employee was let go. Pt's sx have resolved.
Age: 0.15
Sex: M
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Autopsy, Blood culture positive, Culture urine positive, Death, Dyspnoea
Clinical narrative: Within hours of vaccination (night of vaccination day) infant became febrile. At approximately 2:00AM on 1/26/2012, he was taken to hospital because of breathing difficulty. Infant was resuscitated at hospital but expired on 1/27/2012.
Age: 0.15
Sex: M
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Lung infiltration, Pyrexia, Resuscitation, Streptococcus test positive
Clinical narrative: Within hours of vaccination (night of vaccination day) infant became febrile. At approximately 2:00AM on 1/26/2012, he was taken to hospital because of breathing difficulty. Infant was resuscitated at hospital but expired on 1/27/2012.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Blood pressure decreased, Face injury, Heart rate decreased, Loss of consciousness, Syncope
Clinical narrative: Initial report was received from a health care professional on 31 January 2012. A 12-year-old male patient had received an intramuscular injection of MENACTRA, sanofi pasteur Inc., lot number U4271AA (site not reported) on 30 January 2012 and within minutes the patient fainted and loss consciousness for approximately two seconds. The patient's blood pressure and pulse dropped but then recovered. The patient fainted in the shower and hit his face. The patient was going to the office for evaluation. The reporter denied the patient had any illness at the time of vaccination, any pre-existing medical conditions, took any concomitant medications, had any other vaccinations within four weeks of MENACTRA and had any adverse events following prior vaccinations. The patient had no known allergies (NKA). No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 31 January 2012 from the investigator under the reference number M5A16. A case of pertussis disease in a 12-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had previously received 3 doses of PENTACEL on the following dates: 21 January 2011, 21 March 2011 (lot number not reported) and lot number C3872AB on 23 May 2011 (route and site of administration not reported). The subject developed a cough on 11 December 2011, approximately 7 months after the last dose. On 24 December 2011, the subject developed a paroxysmal cough with posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 11 January 2012. Chest x-rays findings were negative for pneumonia. Corrective treatments consisted of azithromycin for 5 days starting on 11 January 2012. The subject was not hospitalized. At the time of final contact on 18 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 38 days. As per protocol, no causality assessment provided by investigator. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 31 January 2012 from the investigator under the reference number M5A16. A case of pertussis disease in a 12-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had previously received 3 doses of PENTACEL on the following dates: 21 January 2011, 21 March 2011 (lot number not reported) and lot number C3872AB on 23 May 2011 (route and site of administration not reported). The subject developed a cough on 11 December 2011, approximately 7 months after the last dose. On 24 December 2011, the subject developed a paroxysmal cough with posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 11 January 2012. Chest x-rays findings were negative for pneumonia. Corrective treatments consisted of azithromycin for 5 days starting on 11 January 2012. The subject was not hospitalized. At the time of final contact on 18 January 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 38 days. As per protocol, no causality assessment provided by investigator. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema multiforme, Injection site erythema, Injection site rash, Skin lesion
Clinical narrative: Initial report was received from a health care professional on 01 February 2012. A 4-year-old male patient had received a first dose of DTaP, sanofi pasteur Inc. (lot number, route and site not reported) on 29 December 2009. Five to six days after the vaccination, the patient developed a rash, which only involved the arm where he received the vaccination. It was described by the patient's mother as "red, flat, non-pruritic, coming and going (but not hives), with multiple red lesions that did not all look alike." The lesions did not itch and the patient did not have eye or mucus membrane changes. The patient was seen the next day (also reported as 05 January 2010) by his pediatrician who thought the rash was consistent with (c/w) erythema multiforme. The pediatrician described the rash as 5-7 irregular oval and circular lesions with red peripheral edges and clearing in the center. The rash resolved within 24 to 48 hours. No additional treatment was offered. At the time of vaccination, the patient was completing a course of amoxicillin for "? sinus infection." The patient was also on treatment with PROVENTIL, albuterol, FLOVENT and mometasone for "? reactive airway disease." The patient's 5-year-old sibling had autism. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Pt. immunized on 2/4/12 with 0.65mL dose of ZOSTAVAX. Pt was monitored for 10 minutes post dose w/o incident. Returned on 2/7/12 with redness, irritation, swelling, itching from injection site to left elbow. Also complained of fever. Pt. referred to MD.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Bordetella test positive, Cough
Clinical narrative: Pt received Tdap vaccine on 6/25/09. Was seen in the office on 1/31/12 for persistent cough for 12 days. Pertussis swab was sent off. Swab (+) for pertussis. Treated w/ azithromycin x5d. Pt. had also received 5 doses of DTaP.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: Redness, itchiness, hot, hard. Was given Benadryl and hardness went down.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Idiopathic thrombocytopenic purpura, Mouth haemorrhage, Petechiae
Clinical narrative: Petechiae on arms, legs and face. Oral bleeding.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Pt described fatigue Friday evening thru Saturday. Adverse event-pt describes having teeth chattering, possible sz in the late night/early morning of Sat/Sun. The remainder of Sunday pt describes feeling achey and having a low grade fever. As of Monday 2/13/2012 pt is feeling "better". Recommended making an appt with PCP.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Local swelling, Pruritus
Clinical narrative: Patient reported area swollen, red, itchy and she felt off over the weekend. There was no action taken. She reports improvement.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling hot, Induration, Injection site erythema
Clinical narrative: Noticed arm sore and hard knot under injection site. Took Tylenol. Had fever/chills all that night. Large red hard area about 3 in around injection site. Started taking Aleve 2 every 8 hours. Blisters began appearing around injection site by Friday morning.  Felt achy and feverish all day.  By Saturday morning entire upper back half of arm extremely red, swollen, hot and most of area hard.  Nurse practicioner prescribed Valtrex 1gm tid x 7 days and Keflex 500mg bid x 7 days.  Large blisters started leaking on Sunday and much more improved with only blister area and about 2 in red area remaining.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site vesicles, Local swelling, Nodule, Pain
Clinical narrative: Noticed arm sore and hard knot under injection site. Took Tylenol. Had fever/chills all that night. Large red hard area about 3 in around injection site. Started taking Aleve 2 every 8 hours. Blisters began appearing around injection site by Friday morning.  Felt achy and feverish all day.  By Saturday morning entire upper back half of arm extremely red, swollen, hot and most of area hard.  Nurse practicioner prescribed Valtrex 1gm tid x 7 days and Keflex 500mg bid x 7 days.  Large blisters started leaking on Sunday and much more improved with only blister area and about 2 in red area remaining.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Noticed arm sore and hard knot under injection site. Took Tylenol. Had fever/chills all that night. Large red hard area about 3 in around injection site. Started taking Aleve 2 every 8 hours. Blisters began appearing around injection site by Friday morning.  Felt achy and feverish all day.  By Saturday morning entire upper back half of arm extremely red, swollen, hot and most of area hard.  Nurse practicioner prescribed Valtrex 1gm tid x 7 days and Keflex 500mg bid x 7 days.  Large blisters started leaking on Sunday and much more improved with only blister area and about 2 in red area remaining.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Warm, red, indurated area on right upper arm lasting 4-5 days; no fever or rash.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Localized red /hot area at vaccination site saw Dr. 2/8/2012 treated with topical steroid cream.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: Headache.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: Red/swollen.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Myalgia, Pain, Pain in extremity, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old female patient with none pertinent medical history and none drug allergies, who on 09-DEC-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# 671662/1160AA) (exp. 18-OCT-2012). Concomitant therapy included hormones (unspecified). On 13-DEC-2011, the patient developed a burning pain (described as a sunburn like pain, no rash) in her left thigh and back (kidney area) following vaccination with ZOSTAVAX (Merck). The patient contact with the pharmacy on 14-DEC-2011, about the burning pain. The burning pain developed in the evening of 13-DEC-2011, in the left thigh area. On 14-DEC-2011, the burning pain seemed to get slightly better, but on 15-DEC-2011, the burning pain had spread to the left lower back (kidney area). The burning pain was still present in the left thigh on 15-DEC-2011. No treatment was given for adverse events. The patient contacted the pharmacist. At the time of the report the patient's status was not recovered. Follow up information has been received from a pharmacist concerning a patient, professor, with allergy (seasonal only), no illness at time of vaccination and no adverse events following prior vaccinations, who on 09-DEC-2011 at 2:45 PM, was vaccinated with a first dose of ZOSTAVAX (Merck) (SC, left deltoid, dose not reported) (Lot# 671139/1265AA). The pharmacist reported that on 11-DEC-2011 at 4:00 PM, the patient developed sciatic on left leg involving from hip to left ankle, deep muscle pain, and surface burning sensation. Duration until 20-JAN-2012. The patient was treated with OTC analgesic. The pharmacist reported that the patient still have burning in shin area and the rash still not resolved. The pharmacist stated that the patient visited her physician. The pharmacist considered reported adverse experiences to be disabling. At the time of the report the outcome of the patient was not recovered. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Sciatica
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old female patient with none pertinent medical history and none drug allergies, who on 09-DEC-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# 671662/1160AA) (exp. 18-OCT-2012). Concomitant therapy included hormones (unspecified). On 13-DEC-2011, the patient developed a burning pain (described as a sunburn like pain, no rash) in her left thigh and back (kidney area) following vaccination with ZOSTAVAX (Merck). The patient contact with the pharmacy on 14-DEC-2011, about the burning pain. The burning pain developed in the evening of 13-DEC-2011, in the left thigh area. On 14-DEC-2011, the burning pain seemed to get slightly better, but on 15-DEC-2011, the burning pain had spread to the left lower back (kidney area). The burning pain was still present in the left thigh on 15-DEC-2011. No treatment was given for adverse events. The patient contacted the pharmacist. At the time of the report the patient's status was not recovered. Follow up information has been received from a pharmacist concerning a patient, professor, with allergy (seasonal only), no illness at time of vaccination and no adverse events following prior vaccinations, who on 09-DEC-2011 at 2:45 PM, was vaccinated with a first dose of ZOSTAVAX (Merck) (SC, left deltoid, dose not reported) (Lot# 671139/1265AA). The pharmacist reported that on 11-DEC-2011 at 4:00 PM, the patient developed sciatic on left leg involving from hip to left ankle, deep muscle pain, and surface burning sensation. Duration until 20-JAN-2012. The patient was treated with OTC analgesic. The pharmacist reported that the patient still have burning in shin area and the rash still not resolved. The pharmacist stated that the patient visited her physician. The pharmacist considered reported adverse experiences to be disabling. At the time of the report the outcome of the patient was not recovered. Additional information has been requested.
Age: 0.88
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Ear infection, Erythema, Injection site reaction, Rash erythematous
Clinical narrative: Pt saw Dr on Sat 2-11-12. Dr reported events to me today. Bright red rash encircled injection site on RT, went up thigh to groin area, also had large red patch on neck and axilla.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Pt developed itching and hives within minutes of receiving TDAP/BOOSTRIX vaccine in (L) deltoid. Hives around eyes and at injection site. Pt was given 2 tsp of BENADRYL in office and within 20 minutes hives improved with minimal itching. Pt was sent home.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Body temperature increased, Malaise, Myalgia, Rash erythematous
Clinical narrative: Malaise today following vaccine. Temp 103-104 degrees F days 2 and after vaccine with myalgia, arthralgia and rash with erythema, pruritic papules over left shoulder and left upper area above scapular appears to be improved today.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Malaise today following vaccine. Temp 103-104 degrees F days 2 and after vaccine with myalgia, arthralgia and rash with erythema, pruritic papules over left shoulder and left upper area above scapular appears to be improved today.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Body temperature increased, Pain in extremity
Clinical narrative: Pain in both legs. Temperature of 100 degrees F.
Age: 18.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis RUE deltoid where received PNVX. Required change of antibiotic to KEFLEX from Amoxicillin for sinus infection treated prior.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and itching at the injection site to an area of 10 x 10 cms in diameter. Patient c/o pain on pressure to the area.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Muscular weakness, Myelitis transverse
Clinical narrative: Patient states she began experiencing leg and knee weakness.  Initially saw orthopedist who administered a cortisone shot.  When symptoms did not go away, she was referred to a neurologist who diagnosed transverse myelitis.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Blood test normal, Fatigue, Gait disturbance
Clinical narrative: Arm joint area where vaccine needle given weakened and sore - almost unable to use.  Pain in knees-going from one knee to the other where I was unable to walk far.  Body seems weak and I am very fatigue.  Another doctor was recommended.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: Arm joint area where vaccine needle given weakened and sore - almost unable to use.  Pain in knees-going from one knee to the other where I was unable to walk far.  Body seems weak and I am very fatigue.  Another doctor was recommended.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Softball sized area of redness centered at vaccination site and pt complains of pruritis starting 2/11/12 and continuing today (2/13/12).  Pt has been icing intermittently.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching; developed hives; took Benadryl.
Age: 18.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Decreased appetite, Escherichia test positive, Malaise, Pain, Pyrexia
Clinical narrative: Pt presented to the clinic on 02/06 with complaints of generalized aching, malaise, and poor appetite. Returned to clinic on 02/07 with same symptoms, WBC 22,000, started on Levaquin and Flagyl. On 02/08 reported fever the night before of 101, WBC 24,000 and was admitted to hospital. Pt did have a urinary tract infection, as well.
Age: 18.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urinary tract infection, White blood cell count increased
Clinical narrative: Pt presented to the clinic on 02/06 with complaints of generalized aching, malaise, and poor appetite. Returned to clinic on 02/07 with same symptoms, WBC 22,000, started on Levaquin and Flagyl. On 02/08 reported fever the night before of 101, WBC 24,000 and was admitted to hospital. Pt did have a urinary tract infection, as well.
Age: 0.18
Sex: F
Vaccine: 6VAX-F, RVX
Symptoms: Crying
Clinical narrative: Uncontrollable crying for 4 hours.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: High fever (105 degrees), febrile seizure.
Age: 0.16
Sex: M
Vaccine: 6VAX-F, OPV, PPV, RV1
Symptoms: Abnormal behaviour, Childhood disintegrative disorder, Crying, Decreased eye contact, Emotional distress
Clinical narrative: High pitch scream different cry than usual, very restless, unable to be consoled, regressed from progress made, lack of head control, throwing back head abruptly while screaming, extreme side to side movement, very lethargic, does not engage in eyes contact or engage verbally when spoken to, was cooing, and babbling with parents but seems like a different baby, has not slept more than 3 hours since 02/13/2012. Does not seem to be satisfied after feeding, wakes up in the middle of the night with a shrill scream about every hour and half, sometimes 45 minutes. Baby has changed since vaccinations.
Age: 0.16
Sex: M
Vaccine: 6VAX-F, OPV, PPV, RV1
Symptoms: Immediate post-injection reaction, Insomnia, Irritability, Lethargy, Middle insomnia
Clinical narrative: High pitch scream different cry than usual, very restless, unable to be consoled, regressed from progress made, lack of head control, throwing back head abruptly while screaming, extreme side to side movement, very lethargic, does not engage in eyes contact or engage verbally when spoken to, was cooing, and babbling with parents but seems like a different baby, has not slept more than 3 hours since 02/13/2012. Does not seem to be satisfied after feeding, wakes up in the middle of the night with a shrill scream about every hour and half, sometimes 45 minutes. Baby has changed since vaccinations.
Age: 0.16
Sex: M
Vaccine: 6VAX-F, OPV, PPV, RV1
Symptoms: Movement disorder, Posture abnormal, Restlessness, Screaming, Unresponsive to stimuli
Clinical narrative: High pitch scream different cry than usual, very restless, unable to be consoled, regressed from progress made, lack of head control, throwing back head abruptly while screaming, extreme side to side movement, very lethargic, does not engage in eyes contact or engage verbally when spoken to, was cooing, and babbling with parents but seems like a different baby, has not slept more than 3 hours since 02/13/2012. Does not seem to be satisfied after feeding, wakes up in the middle of the night with a shrill scream about every hour and half, sometimes 45 minutes. Baby has changed since vaccinations.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Gaze palsy, Heart rate decreased, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Within 2 days of getting the vaccines client's eyes rolled back. He slumped over was unresponsive for a few mins. Client then pale, diaphoretic, low heart beat 58. BP 120/60. Client remained sleepy and appeared to be going in and out of consciousness. Client vomited. After 10 mins the EMS was called. Client taken to ER for further evaluation.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Somnolence, Unresponsive to stimuli, Vomiting
Clinical narrative: Within 2 days of getting the vaccines client's eyes rolled back. He slumped over was unresponsive for a few mins. Client then pale, diaphoretic, low heart beat 58. BP 120/60. Client remained sleepy and appeared to be going in and out of consciousness. Client vomited. After 10 mins the EMS was called. Client taken to ER for further evaluation.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Erythema, Hypersensitivity
Clinical narrative: C/O intermittent shortness of breath after receiving flu vaccine. Mild erythema seen in Ed. Treated with steroids, BENADRYL. Last year had mild itching at site NKA. Also reported chest pain had (-) EKG transferred to ED for eval.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: C/O intermittent shortness of breath after receiving flu vaccine. Mild erythema seen in Ed. Treated with steroids, BENADRYL. Last year had mild itching at site NKA. Also reported chest pain had (-) EKG transferred to ED for eval.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Fever, injection sites are red and hard 3 cm bilateral painful indurated areas of anterior thighs.
Age: 17.0
Sex: M
Vaccine: FLU3, HEP, HEPA, HPV4, MMR, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Rash maculo-papular
Clinical narrative: FEVER 4 DAYS, MACRO-PAPULAR RASH ON TRUNK, REDNESS AND SWELLING AT VACCINE SITE (LEFT ARM).
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Child developed "hives" on his head and neck.  Was taken to family physician who described hives as "atypical".  Given steroids.  One day later after seeing MD (02/09/2012) hives had spread to waist and trunk of body.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Hypersensitivity, Papule, Swelling face
Clinical narrative: FACIAL REDNESS, FACIAL SWELLING, FINE RED FACIAL PAPULES AND FINE RED UPPER EXTREMITY PAPULES WITHIN 5 MINUTES OF ADMINISTERING MMR, Dtap and IPV IMMUNIZATIONS.
Age: 58.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site induration, Lymphadenitis, Lymphadenopathy
Clinical narrative: Developed erythema on L deltoid injection site with induration. Lymph glands in axilla swollen and tender. Did not seek medical treatment. Today (02/13/2012) is not worsening, but still present.
Age: 42.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site pain, Oedema, Pruritus, Skin discolouration
Clinical narrative: Soreness at injection site; edema (size of a palm/hand); itchy; skin discoloration.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Pink swelling and itchy around injection area. Other than that patient feels fine overall.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Agitation, Crying, Lip swelling, Pruritus, Tachycardia
Clinical narrative: About 30 minutes after receiving 5 vaccines and ibuprofen, developed small welts on face, legs, arms, trunk, very, very itchy. Agitated tachycardia, lower lip swelled, crying.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: About 30 minutes after receiving 5 vaccines and ibuprofen, developed small welts on face, legs, arms, trunk, very, very itchy. Agitated tachycardia, lower lip swelled, crying.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Soreness, moderate to severe itching, raised dark pink 2" x 3" arm around injection site starting 24 hrs after injection. Patient applied hydrocortisone lotion to arm 48 hr post injection and again 72 hr post injection w/ improvement.