chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, VARCEL, MMR
Symptoms: Abdominal discomfort, Body temperature increased, Feeling abnormal, Feeling hot, Rash
Clinical narrative: Last night my daughter complained of an upset stomach that she felt "queasy" she felt hot, I took her temperature and it was 101.6 Tylenol was given. When she woke up this morning I took temp and it was normal at 6:00am 98.6 but when we started to get dressed I noticed a rash on her shoulders, back and under her arms. Temp rose to a low grade today of 99.3.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, VARCEL, MMR
Symptoms: Oropharyngeal pain, Pyrexia, Rash generalised
Clinical narrative: Last night my daughter complained of an upset stomach that she felt "queasy" she felt hot, I took her temperature and it was 101.6 Tylenol was given. When she woke up this morning I took temp and it was normal at 6:00am 98.6 but when we started to get dressed I noticed a rash on her shoulders, back and under her arms. Temp rose to a low grade today of 99.3.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Right arm extremely achy for several days (4) after the event without improving.  I have never had a shot be so sore and so severely for so many days following an immunization.  I would rate the pain as a "6" on a scale of 1-10.  The pain was so severe it would wake me up in the middle on the night several times when the ibuprofen would wear off.  My range of motion stayed intact.  I recognize a sore arm is an expected side effect, but this seemed very severe.
Age: 1.14
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Blood culture negative, CSF culture negative, Computerised tomogram head, Computerised tomogram normal, Convulsion
Clinical narrative: Child was napping, when mom heard her cry.  Went into room and child was having a seizure.  EMS was activated after 4-5 mins of seizure activity.  Child was sent to ER via Air Med.  While in ER child had 2 prolonged tonic-clonic seizures.  Was admitted to PICU x 2 days while awaiting septic workup, then was placed on Pediatric Floor until 3/29/2011.  Neurology was consulted on child.
Age: 1.14
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Culture throat negative, Culture urine negative, Epstein-Barr virus antibody negative, Full blood count abnormal, Grand mal convulsion
Clinical narrative: Child was napping, when mom heard her cry.  Went into room and child was having a seizure.  EMS was activated after 4-5 mins of seizure activity.  Child was sent to ER via Air Med.  While in ER child had 2 prolonged tonic-clonic seizures.  Was admitted to PICU x 2 days while awaiting septic workup, then was placed on Pediatric Floor until 3/29/2011.  Neurology was consulted on child.
Age: 1.14
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Intensive care, Mononucleosis heterophile test negative, Streptococcus test, Streptococcus test negative, White blood cell count decreased
Clinical narrative: Child was napping, when mom heard her cry.  Went into room and child was having a seizure.  EMS was activated after 4-5 mins of seizure activity.  Child was sent to ER via Air Med.  While in ER child had 2 prolonged tonic-clonic seizures.  Was admitted to PICU x 2 days while awaiting septic workup, then was placed on Pediatric Floor until 3/29/2011.  Neurology was consulted on child.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Dyskinesia, Hyperhidrosis, Posture abnormal, Vomiting
Clinical narrative: At 1:30 PM, patient received an IM of Boostrix to his Left Deltoid.  When he moved to the observation area and was seated in a student desk (within 1 - 2 minutes after IM) he slumped to his right side braced by a crossbar on the desk with his head/arms dangling.  He had jerking movements in the trunk of his body for about 10 seconds.  He was repositioned with his head and arms on the desktop and rested.  He began vomiting small amounts of clear liquid and was sweating.  He fully recovered within ~ 3 minutes.  Stated he hadn't eaten that day.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: prolonged deltoid muscle pain-present at least 12 days after immunization
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea, Irritability, Pain, Pyrexia, Rash
Clinical narrative: Vomiting, diarrhea, fever, rash, fatigue, irritability, body aches and pains
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Vomiting, diarrhea, fever, rash, fatigue, irritability, body aches and pains
Age: 1.04
Sex: F
Vaccine: HEP, MMRV, PNC13
Symptoms: Body temperature increased, Full blood count normal, Petechiae, Platelet count normal, Rash
Clinical narrative: 12 days after MMR-V - measles rash - confluent, red raised face, trunk, extremities including palms & soles. (not just scattered pink spots!). No occipital nodes. No splenomegaly. No mucous membrane involvement. No cough. Slight runny nose. T=101 degrees-102 degrees x 48 hrs. Patient is ex-premature infant 31 weeks gestation, otherwise well. Rash became petechial, but no ecchymosis. CBC was normal with nl. platelet ct. Rash faded after 1 week.
Age: 1.04
Sex: F
Vaccine: HEP, MMRV, PNC13
Symptoms: Rash erythematous, Rash morbilliform, Rhinorrhoea
Clinical narrative: 12 days after MMR-V - measles rash - confluent, red raised face, trunk, extremities including palms & soles. (not just scattered pink spots!). No occipital nodes. No splenomegaly. No mucous membrane involvement. No cough. Slight runny nose. T=101 degrees-102 degrees x 48 hrs. Patient is ex-premature infant 31 weeks gestation, otherwise well. Rash became petechial, but no ecchymosis. CBC was normal with nl. platelet ct. Rash faded after 1 week.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Induration
Clinical narrative: Local significant indurated reaction 5 x 5 cm.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Received Hep B vaccine on 6/30/11. She called Dr. office on 7/2/11 stating that she was experiencing numbness and tingling from elbow to wrist in injection arm. She denied any other symptoms.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Arm swollen & red 4cm x 4cm (L) deltoid area - around spot where shot was given - swelling and tenderness noted.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Injected Thurs. afternoon by Friday night experienced Flu-like symptoms. Low grade fever, muscle aches, joint aches, fatigue & chills. Took TYLENOL. 6/29 - feeling better.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Injected Thurs. afternoon by Friday night experienced Flu-like symptoms. Low grade fever, muscle aches, joint aches, fatigue & chills. Took TYLENOL. 6/29 - feeling better.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Injection site erythema, Skin lesion, Vaccination site inflammation, Vaccination site pain
Clinical narrative: Pt woke with a large red, painful inflamed lesion at vaccine site that was given yesterday 6-28-11. The raised site measured approx 3 inches in length and 2 inches in width. No fever or shortness of breath noted.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Adverse reaction, Cellulitis, Injection site oedema, Injection site warmth
Clinical narrative: (L) deltoid muscle warm, mild edema 15 in length by 14 in width. Cellulitis vs reaction / antibiotic given.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Pt passed out 15 minutes after vax. Hit head during fall. Recovered.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Passed out 15 minutes after vaccine. Hit head on fall. Recovered.
Age: 1.89
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL, DTAPIPVHIB, MMR, VARCEL
Symptoms: Musculoskeletal stiffness
Clinical narrative: Initial report was received from a health care professional on 06 April 2011. A 22 month-old (reported as 18 months) male with no report past medical history had received on 10 January 2011 a first dose of PENTACEL (lot number, route and site of administration not reported), a first dose of MMR (Merck lot number, route and site of administration not reported) and a first dose of VARIVAX (Merck lot number, route and site of administration not reported). On 18 January 2011, the patient developed a blank stare and stiffness lasting a few seconds. The reporter states the Mother questioned whether it was a seizure. The patient received subsequent vaccines of DAPTACEL, IPOL and PREVNAR on 09 February 2011 and DAPTACEL, IPOL and Hep B on 08 March 2011 without incident. Treatments and concomitant medications were not reported. Illness at the time of vaccination was denied and the patient had no other vaccinations within four weeks prior of the suspect vaccines. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 1.89
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL, DTAPIPVHIB, MMR, VARCEL
Symptoms: Musculoskeletal stiffness, Staring
Clinical narrative: Initial report was received from a health care professional on 06 April 2011. A 22 month-old (reported as 18 months) male with no report past medical history had received on 10 January 2011 a first dose of PENTACEL (lot number, route and site of administration not reported), a first dose of MMR (Merck lot number, route and site of administration not reported) and a first dose of VARIVAX (Merck lot number, route and site of administration not reported). On 18 January 2011, the patient developed a blank stare and stiffness lasting a few seconds. The reporter states the Mother questioned whether it was a seizure. The patient received subsequent vaccines of DAPTACEL, IPOL and PREVNAR on 09 February 2011 and DAPTACEL, IPOL and Hep B on 08 March 2011 without incident. Treatments and concomitant medications were not reported. Illness at the time of vaccination was denied and the patient had no other vaccinations within four weeks prior of the suspect vaccines. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB
Symptoms: Endotracheal intubation, Haemophilus test positive, Intensive care, Malaise, Respiratory distress
Clinical narrative: Initial report was received from a health care professional on 23 February 2011. A six month-old male patient who had received 2 previous doses of PENTACEL on the proper schedule (lot number, route, site and dates of administration not reported), became very sick. The patient was reported to be in severe respiratory distress. He was intubated and hospitalized in the intensive care unit (dates not reported). Laboratory studies were positive for Haemophilus B - Biotype III. Treatments were not reported. The patient had no illness at the time of prior vaccinations and it was unknown if he had any adverse events following the prior vaccinations. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 22 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 11 month old female subject (initials not collected) was identified by the investigator based on review of data the Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and on 08 February 2011 approximately five months after the last dose, developed a cough. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, although PCR was negative on 28 February 2011, this case was epidemiologically linked to laboratory confirmed case (twin sibling captured in case number 2011-01491). Investigator causality assessment is not required as per protocol. Documents held by sender: None
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 22 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 11 month old female subject (initials not collected) was identified by the investigator based on review of data the Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and on 08 February 2011 approximately five months after the last dose, developed a cough. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, although PCR was negative on 28 February 2011, this case was epidemiologically linked to laboratory confirmed case (twin sibling captured in case number 2011-01491). Investigator causality assessment is not required as per protocol. Documents held by sender: None
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test normal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 22 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 11 month old female subject (initials not collected) was identified by the investigator based on review of data the Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and on 08 February 2011 approximately five months after the last dose, developed a cough. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, although PCR was negative on 28 February 2011, this case was epidemiologically linked to laboratory confirmed case (twin sibling captured in case number 2011-01491). Investigator causality assessment is not required as per protocol. Documents held by sender: None
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 22 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 11 month old female subject (initials not collected) was identified by the investigator based on review of data the Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and on 08 February 2011 approximately five months after the last dose, developed a cough. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, although PCR was negative on 28 February 2011, this case was epidemiologically linked to laboratory confirmed case (twin sibling captured in case number 2011-01491). Investigator causality assessment is not required as per protocol. Documents held by sender: None
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sick relative, Sleep disorder
Clinical narrative: Initial report received on 22 March 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an 11 month old female subject (initials not collected) was identified by the investigator based on review of data the Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL; lot number C3552AA/C3670AA received on 08 September 2010, lot number C3512AA received on 08 July 2010 and lot number C3421AA/C3554AA received on 04 May 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms (date not reported), and on 08 February 2011 approximately five months after the last dose, developed a cough. On 26 February 2011, the subject developed a paroxysmal cough without whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 01 March 2011 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 01 March 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, although PCR was negative on 28 February 2011, this case was epidemiologically linked to laboratory confirmed case (twin sibling captured in case number 2011-01491). Investigator causality assessment is not required as per protocol. Documents held by sender: None
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain, Abdominal pain lower, Culture stool negative, Guillain-Barre syndrome, Helicobacter test negative
Clinical narrative: Numbness, tingling in hands, feet. Weakness in lower body. Headache 1st day. Severe pain in lower rt abdomen. Severe pain in legs and knees. Unable to walk. Diagnosed w/Guillain Barre.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Numbness, tingling in hands, feet. Weakness in lower body. Headache 1st day. Severe pain in lower rt abdomen. Severe pain in legs and knees. Unable to walk. Diagnosed w/Guillain Barre.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abasia, Abdominal pain lower, Arthralgia, Asthenia, Guillain-Barre syndrome
Clinical narrative: Numbness, tingling in hands, feet. Weakness in lower body. Headache 1st day. Severe pain in lower rt abdomen. Severe pain in legs and knees. Unable to walk. Diagnosed w/Guillain Barre.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Headache, Hypoaesthesia, Lumbar puncture, Pain in extremity, Paraesthesia
Clinical narrative: Numbness, tingling in hands, feet. Weakness in lower body. Headache 1st day. Severe pain in lower rt abdomen. Severe pain in legs and knees. Unable to walk. Diagnosed w/Guillain Barre.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abasia, Abdominal pain lower, Areflexia, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Numbness, tingling in hands, feet. Weakness in lower body. Headache 1st day. Severe pain in lower rt abdomen. Severe pain in legs and knees. Unable to walk. Diagnosed w/Guillain Barre.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Lumbar puncture abnormal, White blood cell count increased
Clinical narrative: Numbness, tingling in hands, feet. Weakness in lower body. Headache 1st day. Severe pain in lower rt abdomen. Severe pain in legs and knees. Unable to walk. Diagnosed w/Guillain Barre.
Age: 58.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Body temperature increased, Rash
Clinical narrative: Information has been received from a 58 year old female physical therapist reporting on herself with hypothyroidism, arrhythmia, orthostatic hypotension and fibromyalgia, rubella titers less than 5 (4.47) meaning that she had no immunity and titers for mumps were (5.41) very high so she had resistance and no drug reactions or allergies who on 13-JUN-2011, was vaccinated with a dose of MMR II (lot number 666685/0742Z rHA, expire date 19-MAY-2012). Concomitant therapy included natural medicine for thyroid, VALTREX, gabapentin, "MESTININ", labetalol HC1, clonidine, amlodipine and EFFEXOR. On 24-JUN-2011, the therapist began to felt "achy in her hips and shoulders" (more than she normally experienced with fibromyalgia). On 24-JUN-2011, the therapist took a nap and when she woke up she had a fever of 101.4F. The therapist called out of work for the next day because she worked in a hospital. On Saturday 25-JUN-2011, the therapist woke up with a body rash. The rash "covered all areas" of her body, except the soles of her feet and palms of hands. It had been on her face and even her scalp had been itchy. The rash had been on neck and trunk and all limbs. She reported no sores in her mouth. The therapist reported that her eyes were "bloodshot". She reported no vesicles and no fluid discharge. The therapist described the rash as "flat" resembling "goose-bumps". The therapist reported swollen glands in her neck and headache. On 26-JUN-2011, the therapist visited a clinic they gave her no treatment for the event. No laboratories were performed. On 27-JUN-2011, the fever had gone down to 99F. On 28-JUN-2011, the therapist had been having more swollen glands and joint pain. At the time of the report the patient had not recovered. The patient's achy in her hips and shoulders, fever, the body rash in all areas of her body, the itchy scalp, the bloodshot in her eyes, the swollen glands in her neck and the headache were considered to be disabling by the physical therapist. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Headache, Impaired work ability, Lymphadenopathy, Mumps antibody test positive
Clinical narrative: Information has been received from a 58 year old female physical therapist reporting on herself with hypothyroidism, arrhythmia, orthostatic hypotension and fibromyalgia, rubella titers less than 5 (4.47) meaning that she had no immunity and titers for mumps were (5.41) very high so she had resistance and no drug reactions or allergies who on 13-JUN-2011, was vaccinated with a dose of MMR II (lot number 666685/0742Z rHA, expire date 19-MAY-2012). Concomitant therapy included natural medicine for thyroid, VALTREX, gabapentin, "MESTININ", labetalol HC1, clonidine, amlodipine and EFFEXOR. On 24-JUN-2011, the therapist began to felt "achy in her hips and shoulders" (more than she normally experienced with fibromyalgia). On 24-JUN-2011, the therapist took a nap and when she woke up she had a fever of 101.4F. The therapist called out of work for the next day because she worked in a hospital. On Saturday 25-JUN-2011, the therapist woke up with a body rash. The rash "covered all areas" of her body, except the soles of her feet and palms of hands. It had been on her face and even her scalp had been itchy. The rash had been on neck and trunk and all limbs. She reported no sores in her mouth. The therapist reported that her eyes were "bloodshot". She reported no vesicles and no fluid discharge. The therapist described the rash as "flat" resembling "goose-bumps". The therapist reported swollen glands in her neck and headache. On 26-JUN-2011, the therapist visited a clinic they gave her no treatment for the event. No laboratories were performed. On 27-JUN-2011, the fever had gone down to 99F. On 28-JUN-2011, the therapist had been having more swollen glands and joint pain. At the time of the report the patient had not recovered. The patient's achy in her hips and shoulders, fever, the body rash in all areas of her body, the itchy scalp, the bloodshot in her eyes, the swollen glands in her neck and the headache were considered to be disabling by the physical therapist. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Musculoskeletal pain, Ocular hyperaemia, Piloerection, Pruritus, Pyrexia
Clinical narrative: Information has been received from a 58 year old female physical therapist reporting on herself with hypothyroidism, arrhythmia, orthostatic hypotension and fibromyalgia, rubella titers less than 5 (4.47) meaning that she had no immunity and titers for mumps were (5.41) very high so she had resistance and no drug reactions or allergies who on 13-JUN-2011, was vaccinated with a dose of MMR II (lot number 666685/0742Z rHA, expire date 19-MAY-2012). Concomitant therapy included natural medicine for thyroid, VALTREX, gabapentin, "MESTININ", labetalol HC1, clonidine, amlodipine and EFFEXOR. On 24-JUN-2011, the therapist began to felt "achy in her hips and shoulders" (more than she normally experienced with fibromyalgia). On 24-JUN-2011, the therapist took a nap and when she woke up she had a fever of 101.4F. The therapist called out of work for the next day because she worked in a hospital. On Saturday 25-JUN-2011, the therapist woke up with a body rash. The rash "covered all areas" of her body, except the soles of her feet and palms of hands. It had been on her face and even her scalp had been itchy. The rash had been on neck and trunk and all limbs. She reported no sores in her mouth. The therapist reported that her eyes were "bloodshot". She reported no vesicles and no fluid discharge. The therapist described the rash as "flat" resembling "goose-bumps". The therapist reported swollen glands in her neck and headache. On 26-JUN-2011, the therapist visited a clinic they gave her no treatment for the event. No laboratories were performed. On 27-JUN-2011, the fever had gone down to 99F. On 28-JUN-2011, the therapist had been having more swollen glands and joint pain. At the time of the report the patient had not recovered. The patient's achy in her hips and shoulders, fever, the body rash in all areas of her body, the itchy scalp, the bloodshot in her eyes, the swollen glands in her neck and the headache were considered to be disabling by the physical therapist. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Rash generalised, Rubella antibody negative
Clinical narrative: Information has been received from a 58 year old female physical therapist reporting on herself with hypothyroidism, arrhythmia, orthostatic hypotension and fibromyalgia, rubella titers less than 5 (4.47) meaning that she had no immunity and titers for mumps were (5.41) very high so she had resistance and no drug reactions or allergies who on 13-JUN-2011, was vaccinated with a dose of MMR II (lot number 666685/0742Z rHA, expire date 19-MAY-2012). Concomitant therapy included natural medicine for thyroid, VALTREX, gabapentin, "MESTININ", labetalol HC1, clonidine, amlodipine and EFFEXOR. On 24-JUN-2011, the therapist began to felt "achy in her hips and shoulders" (more than she normally experienced with fibromyalgia). On 24-JUN-2011, the therapist took a nap and when she woke up she had a fever of 101.4F. The therapist called out of work for the next day because she worked in a hospital. On Saturday 25-JUN-2011, the therapist woke up with a body rash. The rash "covered all areas" of her body, except the soles of her feet and palms of hands. It had been on her face and even her scalp had been itchy. The rash had been on neck and trunk and all limbs. She reported no sores in her mouth. The therapist reported that her eyes were "bloodshot". She reported no vesicles and no fluid discharge. The therapist described the rash as "flat" resembling "goose-bumps". The therapist reported swollen glands in her neck and headache. On 26-JUN-2011, the therapist visited a clinic they gave her no treatment for the event. No laboratories were performed. On 27-JUN-2011, the fever had gone down to 99F. On 28-JUN-2011, the therapist had been having more swollen glands and joint pain. At the time of the report the patient had not recovered. The patient's achy in her hips and shoulders, fever, the body rash in all areas of her body, the itchy scalp, the bloodshot in her eyes, the swollen glands in her neck and the headache were considered to be disabling by the physical therapist. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: MMR, TD, MMR, TDAP
Symptoms: Erythema, Hypersensitivity, Swelling face
Clinical narrative: Facial swelling & redness. Treated with BENADRYL.
Age: 45.0
Sex: M
Vaccine: MMR, TD, MMR, TDAP
Symptoms: Erythema, Swelling face
Clinical narrative: Facial swelling & redness. Treated with BENADRYL.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Local reaction for 1 wk duration 10x10 cm erythema/induration OTC Ibuprofen.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Dysphonia, Electrocardiogram normal, Palpitations, Throat irritation
Clinical narrative: C/o heart racing and "thickness in throat" within 1/2 hr of vaccine.  Seen in ED HR 70s, BP 163/83 RR20 SpO2 100% on RA.  NSR on ECG. Treated with Prednisone 40mg po and Pepcid 40mg po.  D/c home on Benadryl po and Prednisone PO @ 4:40pm. 7/7/11 c/o diarrhea 4 hours after vaccine, now resolved.  Continues to c/o hoarseness and "lump in chest".
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: 2" diameter reddened area at injection site.
Age: 35.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Abdominal pain upper, Chills, Headache, Influenza like illness, Nausea
Clinical narrative: Head Ache, Nausea, abdominal stomach pain, flu like symptoms, Chills and fever, night sweats. Motrin was given to treat symptoms also Ultram and Tylenol.
Age: 35.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Night sweats, Pyrexia, Urine analysis
Clinical narrative: Head Ache, Nausea, abdominal stomach pain, flu like symptoms, Chills and fever, night sweats. Motrin was given to treat symptoms also Ultram and Tylenol.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash all over body, fever (T Max 99.5) - Benadryl was given in office and pt referred to allergy/immunology clinic. Follow up for eval and call if symptoms are worse.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Swelling, fever 104, within 24 hrs, hospitalized 2 days given Abx.
Age: 1.62
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Allergy test negative, Urticaria
Clinical narrative: Seen in office 6/27/11 for evaluation of urticaria. Mild and gradually worsening past 2 days. Multiple exposures for the first time including peanut butter and almonds. Immunization for hepA and DTaP day before hives developed. Skin with diffuse, red, raised urticarial lesions. Eyes/mouth normal. No other sx.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Shots given 6-8-11. Several seizures beginning 6-11-11 --> 6-15-11. No fever noted. Hospitalized 6-11-11 --> 6-15-11.
Age: 0.18
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: After receiving the rotavirus vaccine, on 4-28-2011 the patient experienced diarrhea for 7 days.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Lightheaded, pale, sweaty - about 5 minutes after vaccines given. Pt. was helped to a bed, feet elevated, and fluids. Mom in room at all times. Gradually sat up, then stood. Escorted out  by mom. Episode lasted 15 minutes.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Rash macular, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Red, warm, blotchy to vaccine site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin burning sensation, Vaccination site rash
Clinical narrative: Pt experienced burning under arm 1-2 days after vaccine was administered and vaccine rash appeared 5 days after administration. Recommended pt contact family physician. Pt saw family physician and they ruled it as a mild case of shingles. No tx.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying
Clinical narrative: Uncontrollable crying for hours after vaccines were given.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Oedema peripheral, Pain in extremity
Clinical narrative: 6/30/11 Received call from pt. She stated her entire arm and hand was swollen and very painful, started yesterday. There was an area of redness from injection site to elbow. Went to Urgent Care. Prescribed BACTRIM and apply cold compress.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash
Clinical narrative: Rash on (L) thigh with mild severity & gradual onset x 2 days.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Emotional distress, Screaming
Clinical narrative: Screaming, inconsolable, total time greater than or equal to 8 hours.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Allergy test, Allergy test positive, Immunology test abnormal, Injection site urticaria, Latex allergy
Clinical narrative: 24 hours after vaccines administered child broke out in hives on legs only. She also had fever of 101. Signs & symptoms resolved after about 2 hours with the use of BENADRYL 1/2 tsp. The rash resumed the next day of abdomen, face & right upper arm. BENADRYL given again.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: 24 hours after vaccines administered child broke out in hives on legs only. She also had fever of 101. Signs & symptoms resolved after about 2 hours with the use of BENADRYL 1/2 tsp. The rash resumed the next day of abdomen, face & right upper arm. BENADRYL given again.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Ear pain, Headache, Herpes zoster, Neck pain
Clinical narrative: Developed shingles on back of head - right side - severe headache, earache, neck, blisters.
Sex: M
Vaccine: FLUX
Symptoms: Decreased immune responsiveness, Dyspnoea, Malaise, Ocular hyperaemia, Pertussis
Clinical narrative: Initial case received from a consumer on 27 June 2011. A male patient, who was 36 years old at the time of the report, received an influenza vaccine (manufacturer and lot not reported) approximately 2 years ago. He reacted adversely to the event, and noted that his immunity had gone "down a lot" since vaccination. He was subsequently exposed to large groups of children, many of whom had symptoms of coughing, and also became ill. He presented to his physician with struggle of breath and redness of eyes, and was diagnosed with pertussis. Treatment included Z-PAK. Outcome was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Initial case received from a consumer on 27 June 2011. A male patient, who was 36 years old at the time of the report, received an influenza vaccine (manufacturer and lot not reported) approximately 2 years ago. He reacted adversely to the event, and noted that his immunity had gone "down a lot" since vaccination. He was subsequently exposed to large groups of children, many of whom had symptoms of coughing, and also became ill. He presented to his physician with struggle of breath and redness of eyes, and was diagnosed with pertussis. Treatment included Z-PAK. Outcome was not reported.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Immediate post-injection reaction, Local reaction, Pain
Clinical narrative: Immediate local reaction - redness, warmth, no pruritus reported. Soreness, swelling. Advised cold pack, BENADRYL if needed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Immediate local reaction - redness, warmth, no pruritus reported. Soreness, swelling. Advised cold pack, BENADRYL if needed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Pruritus, Rash
Clinical narrative: Vaccine on 5-26-11 -> severe dizziness on 5-28-11. Noted - redness, rash, & itching by 5-31-11 -> only on each breast & still has this problem as of 6-28-11 - used OTC DRAMAMINE.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site redness, heat, slight swelling at site approx 2" diameter.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash papular, Skin lesion
Clinical narrative: Hive-like lesion (R) thigh 5" x 4 1/2" tiny lesions back of thigh & front of thigh papules (L) wrist x 14 days face & back of knees.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 5.5 cm red, round, slightly raised area at site (R)MT of injection. No pain.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Swelling, Tenderness
Clinical narrative: Tdap administered on 7/5/11. Seen on 7/6/11 for 2-3cm area of swelling. Mildly tender to palpation.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, itching & discomfort at injection site. Warmth & increasing symptoms 2nd day - initiated antibiotic & Hydrocortisone cream topically.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site redness, heat slight swelling at site approx 3 1/2" diameter.
Age: 27.0
Sex: U
Vaccine: YF
Symptoms: Erythema, Injection site swelling, Pruritus
Clinical narrative: Swelling at injection site, redness, and itchy arm.
Age: 45.0
Sex: M
Vaccine: IPV, JEV1, MMR, MNQ
Symptoms: Erythema, Immediate post-injection reaction, Urticaria
Clinical narrative: Immediately after MMR#2 given - small welt above injection site - about size of dime. Within 20 mins or less area about 2" around reddened. Only dime area raised. Encouraged BENADRYL which client took before left office. Marked redness area so client could keep eye on it - is physician. Checked on client at 4:45pm - as soon as home welt & redness gone - fine.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Colonoscopy, Endoscopy, Irritable bowel syndrome, Laboratory test
Clinical narrative: Information has been received from a pediatric gastroenterologist concerning a 14 year old female patient with no pertinent medical history, and allergy to horse hair, who in December 2010, was vaccinated with the first dose of GARDASIL (lot #, dose and route not reported) at another physician's office. There was no concomitant medication. Physician reported that two to three days after receiving her first dose of GARDASIL, the patient developed a rash from head to toe. On 10-JAN-2011 the patient developed rectal bleeding and abdominal pain and on an unknown date was hospitalized (duration unknown by the physician). The patient's rectal pain and abdominal pain improved but the patient had not recovered. Physician reported that patient also went to the emergency room twice (dates unknown). Physician stated that patient had been seen by multiple physicians and had been evaluated in hospitals. On unknown dates, patient has had unspecified laboratory tests and diagnostic studies, including endoscopy and colonoscopy (results not provided). Physician stated that the patient's diagnosis was not conclusive but that the patient may have had irritable bowel syndrome. Physician reported that patient probably would be scheduled for an endoscopy (date not reported). At the time of the report, patient was improving but continued to have rectal bleeding about every three weeks. Physician also added the patient did not take ZOLOFT, as reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Rectal haemorrhage
Clinical narrative: Information has been received from a pediatric gastroenterologist concerning a 14 year old female patient with no pertinent medical history, and allergy to horse hair, who in December 2010, was vaccinated with the first dose of GARDASIL (lot #, dose and route not reported) at another physician's office. There was no concomitant medication. Physician reported that two to three days after receiving her first dose of GARDASIL, the patient developed a rash from head to toe. On 10-JAN-2011 the patient developed rectal bleeding and abdominal pain and on an unknown date was hospitalized (duration unknown by the physician). The patient's rectal pain and abdominal pain improved but the patient had not recovered. Physician reported that patient also went to the emergency room twice (dates unknown). Physician stated that patient had been seen by multiple physicians and had been evaluated in hospitals. On unknown dates, patient has had unspecified laboratory tests and diagnostic studies, including endoscopy and colonoscopy (results not provided). Physician stated that the patient's diagnosis was not conclusive but that the patient may have had irritable bowel syndrome. Physician reported that patient probably would be scheduled for an endoscopy (date not reported). At the time of the report, patient was improving but continued to have rectal bleeding about every three weeks. Physician also added the patient did not take ZOLOFT, as reported. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Rt. arm swollen, red & warm at injection site softball size. Slowly resolving.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Red hot swollen upper arm 8 x 10 cm. Very red center 4.5 x 5cm gradually resolved.
Age: 43.0
Sex: F
Vaccine: HEPAB
Symptoms: Urticaria
Clinical narrative: Pt came to nurse 10 min after receiving 2nd TWINRIX vaccine with hives over bilateral arms & abdomen.
Age: 1.06
Sex: M
Vaccine: DTAP
Symptoms: Abasia, Weight bearing difficulty
Clinical narrative: Patient was unable to walk. Left leg did not function properly, could not bear weight. No pain or fever. Symptoms began 1 hour after injection and lasted for 1 hour. Patient recovered.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: About 2 weeks after vaccination, patient complained of hives/itching. Symptoms resolved after antihistamine administered.
Age: 28.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure, Activities of daily living impaired, Blindness, Dizziness, Eye disorder
Clinical narrative: Information has been received from a 28 year old male doctor of pharmacy reporting on himself with a history of chickenpox as a child who on 09-JUN-2011, was preparing a dose of ZOSTAVAX (Merck) (lot number 669639/0613AA, Exp: 30-JUN-2012) while the pharmacist was "knocking out air bubbles, the vaccine splashed" into his right eye. The right eye "tingled and was blurry". The eye was flushed with water but had been still "not normal". The pharmacist did not seek medical attention. At the time of the report the outcome of the patient was unknown. Follow up information has been received from a 28 year old male doctor of pharmacy reporting on himself who stated that he was still experiencing daily problem from the eye splash he was experiencing nausea and dizziness. Also the pharmacist said that the vision in his right eye went from 20/20 to 20/40. The pharmacist said that he felt that this was a pretty severe issue and was not clearing up. He stated that he had lost vision and it had been a pretty life changing event. He had seen his family doctor, an "eye doctor" and was scheduled to see a neurologist. He was currently taking ZOFRAN, meclizine and ibuprofen "just to me it through the day". This has had a major negative impact on his daily life. The doctor of pharmacist also reported that she went to an eye specialist who told him that there was damage to his eye, but that it will better. He also said his nausea and dizziness were improving as of today and he did not need to take any of the medicines (today) he was taking for these symptoms. At the time of the report the patient had not recovered from the other symptoms. He would schedule to see a neurologist. Upon internal review, lost vision was determined to be an other important medical event. No further information is available.
Age: 28.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye injury, Eye irrigation, Nausea, Paraesthesia, Vision blurred
Clinical narrative: Information has been received from a 28 year old male doctor of pharmacy reporting on himself with a history of chickenpox as a child who on 09-JUN-2011, was preparing a dose of ZOSTAVAX (Merck) (lot number 669639/0613AA, Exp: 30-JUN-2012) while the pharmacist was "knocking out air bubbles, the vaccine splashed" into his right eye. The right eye "tingled and was blurry". The eye was flushed with water but had been still "not normal". The pharmacist did not seek medical attention. At the time of the report the outcome of the patient was unknown. Follow up information has been received from a 28 year old male doctor of pharmacy reporting on himself who stated that he was still experiencing daily problem from the eye splash he was experiencing nausea and dizziness. Also the pharmacist said that the vision in his right eye went from 20/20 to 20/40. The pharmacist said that he felt that this was a pretty severe issue and was not clearing up. He stated that he had lost vision and it had been a pretty life changing event. He had seen his family doctor, an "eye doctor" and was scheduled to see a neurologist. He was currently taking ZOFRAN, meclizine and ibuprofen "just to me it through the day". This has had a major negative impact on his daily life. The doctor of pharmacist also reported that she went to an eye specialist who told him that there was damage to his eye, but that it will better. He also said his nausea and dizziness were improving as of today and he did not need to take any of the medicines (today) he was taking for these symptoms. At the time of the report the patient had not recovered from the other symptoms. He would schedule to see a neurologist. Upon internal review, lost vision was determined to be an other important medical event. No further information is available.