chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP, IPV, PNC
Symptoms: Rhinorrhoea, Sinusitis, Strabismus, Urinary tract infection
Clinical narrative: This case was reported by a lawyer and described the occurrence of afebrile seizure in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PREVNAR. A physician or other health care professional has not verified this report. Concurrent vaccination included hepatitis B recombinant (manufacturer unspecified) and inactivated poliomyelitis virus vaccine (manufacturer unspecified) both given on 26 August 2005. On 26 August 2005 at 10:00 the subject received 3rd dose of PEDIARIX (unknown). Also on 26 August 2005 the subject received 2nd dose of PREVNAR (unknown). Within 24 hours to three days, the subject developed fever and afebrile seizures. The subject was seen at the physician's office, however, it was unknown if she was hospitalized. On 07 September 2005, medical records reportedly indicated that the subject had a fever for one and a half weeks and was diagnosed with otitis media. In the following months, the subject experienced runny nose, cough, congestion, sinus infection and a urinary tract infection. An MRI performed in approximately January 2006 showed isotropia, clarified by the reporter as crossing eyes and developmental concerns. The subject reportedly has experienced permanent effects fur to the events experienced including immune problems, microcephaly, clarified by the reporter as small head, and she had been diagnosed with Autism. Immune problems were reported as unresolved. The outcome of the other events was not known. This case was assessed as medically serious by GSK. The reporter remarked that the suspect medications were PEDIARIX and PREVNAR or the combination together. He also reported that the subject received the Aventis vaccine for the previous series of PEDIARIX. 60 day Follow-up Information 15-AUG-2006: Microcephly!! Nurological disorders - verbal disturbances - motor & coordination disturbances. No walking - left hand & arm weakness - Heavy metals. We demand compensation! We have statements from other people & doctors - movies - and all medical records - she was fine when she was born !!!!! Her head stopped growing at about 8-9 months when major problems began. Murderers - taking the lives of healthy childrens and flushing it away
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV, DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). There were no concomitant medications and no relevant medical history. On 14 April 2009 at 11:00 the subject received 1st dose of KINRIX (0.5 ml, intramuscular, left arm). On 16 April 2009, 2 days after vaccination with KINRIX, the subject experienced injection site redness and "baseball-sized" bump at injection site. At the time of reporting the outcome of the events were was unspecified. Follow-up received from the healthcare professional 04 May 2009: Previous vaccinations included 4 doses of DTaP (unknown manufacturer) administered on unspecified dates. The subject had not experienced adverse events following previous vaccinations. There were no concomitant vaccinations. The onset date of the events was changed to 15 April 2009, 1 day after vaccination with KINRIX. The diagnosis was reported as localized reaction to immunization with associated signs/symptoms of injection site redness and bump at injection site. The subject was seen in the reporters office on 16 April 2009. The healthcare professional considered it "doubtful" that the events could have been associated with suspected transmission of an infectious agent via a medicinal product. The subject was treated with BENADRYL. On 21 April 2009, the events were resolved. The healthcare professional considered the events possibly related to vaccination with KINRIX. The healthcare professional had reported this case to the Regulatory Agency (reference number 344296).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV, DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). There were no concomitant medications and no relevant medical history. On 14 April 2009 at 11:00 the subject received 1st dose of KINRIX (0.5 ml, intramuscular, left arm). On 16 April 2009, 2 days after vaccination with KINRIX, the subject experienced injection site redness and "baseball-sized" bump at injection site. At the time of reporting the outcome of the events were was unspecified. Follow-up received from the healthcare professional 04 May 2009: Previous vaccinations included 4 doses of DTaP (unknown manufacturer) administered on unspecified dates. The subject had not experienced adverse events following previous vaccinations. There were no concomitant vaccinations. The onset date of the events was changed to 15 April 2009, 1 day after vaccination with KINRIX. The diagnosis was reported as localized reaction to immunization with associated signs/symptoms of injection site redness and bump at injection site. The subject was seen in the reporters office on 16 April 2009. The healthcare professional considered it "doubtful" that the events could have been associated with suspected transmission of an infectious agent via a medicinal product. The subject was treated with BENADRYL. On 21 April 2009, the events were resolved. The healthcare professional considered the events possibly related to vaccination with KINRIX. The healthcare professional had reported this case to the Regulatory Agency (reference number 344296).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV, DTAPIPV
Symptoms: Injection site mass, Injection site swelling, Local reaction, No reaction on previous exposure to drug
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). There were no concomitant medications and no relevant medical history. On 14 April 2009 at 11:00 the subject received 1st dose of KINRIX (0.5 ml, intramuscular, left arm). On 16 April 2009, 2 days after vaccination with KINRIX, the subject experienced injection site redness and "baseball-sized" bump at injection site. At the time of reporting the outcome of the events were was unspecified. Follow-up received from the healthcare professional 04 May 2009: Previous vaccinations included 4 doses of DTaP (unknown manufacturer) administered on unspecified dates. The subject had not experienced adverse events following previous vaccinations. There were no concomitant vaccinations. The onset date of the events was changed to 15 April 2009, 1 day after vaccination with KINRIX. The diagnosis was reported as localized reaction to immunization with associated signs/symptoms of injection site redness and bump at injection site. The subject was seen in the reporters office on 16 April 2009. The healthcare professional considered it "doubtful" that the events could have been associated with suspected transmission of an infectious agent via a medicinal product. The subject was treated with BENADRYL. On 21 April 2009, the events were resolved. The healthcare professional considered the events possibly related to vaccination with KINRIX. The healthcare professional had reported this case to the Regulatory Agency (reference number 344296).
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, C-reactive protein, Chest pain, Dizziness, Dyspnoea
Clinical narrative: She received the first GARDASIL injection on 4/23/2009. Symptoms began developing on 4/24/2009. Initially, she was only dizzy and nauseous. As time progressed she has become sicker. She began having headaches, back pain, chest pain, abdominal pain, muscle weakness, numbness and tingling to feet, nerve pain, near fainting, visual disturbances, back pain, muscle cramps, constant thirst, chronic fatigue. She has been diagnosed with peripheral neuropathy. There are over 15,000 VAERS reports regarding this vaccine and that is only current since April 30. And that number is not accurate. There are many, many more that have not made the connection of their illness being caused by the GARDASIL. How many girls need to be injured and killed by this vaccine before the FDA pulls it from the market? This is the organization that we depend upon to protect us - you have completely failed my once healthy daughter! She is now "one less" healthy teenager!
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Epstein-Barr virus test, Fatigue, Full blood count, Headache, Lymphadenopathy
Clinical narrative: She received the first GARDASIL injection on 4/23/2009. Symptoms began developing on 4/24/2009. Initially, she was only dizzy and nauseous. As time progressed she has become sicker. She began having headaches, back pain, chest pain, abdominal pain, muscle weakness, numbness and tingling to feet, nerve pain, near fainting, visual disturbances, back pain, muscle cramps, constant thirst, chronic fatigue. She has been diagnosed with peripheral neuropathy. There are over 15,000 VAERS reports regarding this vaccine and that is only current since April 30. And that number is not accurate. There are many, many more that have not made the connection of their illness being caused by the GARDASIL. How many girls need to be injured and killed by this vaccine before the FDA pulls it from the market? This is the organization that we depend upon to protect us - you have completely failed my once healthy daughter! She is now "one less" healthy teenager!
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Metabolic function test, Muscular weakness, Nausea, Neuralgia, Neurological examination abnormal
Clinical narrative: She received the first GARDASIL injection on 4/23/2009. Symptoms began developing on 4/24/2009. Initially, she was only dizzy and nauseous. As time progressed she has become sicker. She began having headaches, back pain, chest pain, abdominal pain, muscle weakness, numbness and tingling to feet, nerve pain, near fainting, visual disturbances, back pain, muscle cramps, constant thirst, chronic fatigue. She has been diagnosed with peripheral neuropathy. There are over 15,000 VAERS reports regarding this vaccine and that is only current since April 30. And that number is not accurate. There are many, many more that have not made the connection of their illness being caused by the GARDASIL. How many girls need to be injured and killed by this vaccine before the FDA pulls it from the market? This is the organization that we depend upon to protect us - you have completely failed my once healthy daughter! She is now "one less" healthy teenager!
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Neuropathy peripheral, Paraesthesia, Platelet count, Red blood cell sedimentation rate, Skin burning sensation
Clinical narrative: She received the first GARDASIL injection on 4/23/2009. Symptoms began developing on 4/24/2009. Initially, she was only dizzy and nauseous. As time progressed she has become sicker. She began having headaches, back pain, chest pain, abdominal pain, muscle weakness, numbness and tingling to feet, nerve pain, near fainting, visual disturbances, back pain, muscle cramps, constant thirst, chronic fatigue. She has been diagnosed with peripheral neuropathy. There are over 15,000 VAERS reports regarding this vaccine and that is only current since April 30. And that number is not accurate. There are many, many more that have not made the connection of their illness being caused by the GARDASIL. How many girls need to be injured and killed by this vaccine before the FDA pulls it from the market? This is the organization that we depend upon to protect us - you have completely failed my once healthy daughter! She is now "one less" healthy teenager!
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vaccination complication
Clinical narrative: She received the first GARDASIL injection on 4/23/2009. Symptoms began developing on 4/24/2009. Initially, she was only dizzy and nauseous. As time progressed she has become sicker. She began having headaches, back pain, chest pain, abdominal pain, muscle weakness, numbness and tingling to feet, nerve pain, near fainting, visual disturbances, back pain, muscle cramps, constant thirst, chronic fatigue. She has been diagnosed with peripheral neuropathy. There are over 15,000 VAERS reports regarding this vaccine and that is only current since April 30. And that number is not accurate. There are many, many more that have not made the connection of their illness being caused by the GARDASIL. How many girls need to be injured and killed by this vaccine before the FDA pulls it from the market? This is the organization that we depend upon to protect us - you have completely failed my once healthy daughter! She is now "one less" healthy teenager!
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Back pain, Blood electrolytes, C-reactive protein, Chest X-ray
Clinical narrative: She received the first GARDASIL injection on 4/23/2009. Symptoms began developing on 4/24/2009. Initially, she was only dizzy and nauseous. As time progressed she has become sicker. She began having headaches, back pain, chest pain, abdominal pain, muscle weakness, numbness and tingling to feet, nerve pain, near fainting, visual disturbances, back pain, muscle cramps, constant thirst, chronic fatigue. She has been diagnosed with peripheral neuropathy. There are over 15,000 VAERS reports regarding this vaccine and that is only current since April 30. And that number is not accurate. There are many, many more that have not made the connection of their illness being caused by the GARDASIL. How many girls need to be injured and killed by this vaccine before the FDA pulls it from the market? This is the organization that we depend upon to protect us - you have completely failed my once healthy daughter! She is now "one less" healthy teenager!
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Dizziness, Electrocardiogram, Epstein-Barr virus test, Fatigue
Clinical narrative: She received the first GARDASIL injection on 4/23/2009. Symptoms began developing on 4/24/2009. Initially, she was only dizzy and nauseous. As time progressed she has become sicker. She began having headaches, back pain, chest pain, abdominal pain, muscle weakness, numbness and tingling to feet, nerve pain, near fainting, visual disturbances, back pain, muscle cramps, constant thirst, chronic fatigue. She has been diagnosed with peripheral neuropathy. There are over 15,000 VAERS reports regarding this vaccine and that is only current since April 30. And that number is not accurate. There are many, many more that have not made the connection of their illness being caused by the GARDASIL. How many girls need to be injured and killed by this vaccine before the FDA pulls it from the market? This is the organization that we depend upon to protect us - you have completely failed my once healthy daughter! She is now "one less" healthy teenager!
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Full blood count, Headache, Hypoaesthesia, Laboratory test, Muscle spasms
Clinical narrative: She received the first GARDASIL injection on 4/23/2009. Symptoms began developing on 4/24/2009. Initially, she was only dizzy and nauseous. As time progressed she has become sicker. She began having headaches, back pain, chest pain, abdominal pain, muscle weakness, numbness and tingling to feet, nerve pain, near fainting, visual disturbances, back pain, muscle cramps, constant thirst, chronic fatigue. She has been diagnosed with peripheral neuropathy. There are over 15,000 VAERS reports regarding this vaccine and that is only current since April 30. And that number is not accurate. There are many, many more that have not made the connection of their illness being caused by the GARDASIL. How many girls need to be injured and killed by this vaccine before the FDA pulls it from the market? This is the organization that we depend upon to protect us - you have completely failed my once healthy daughter! She is now "one less" healthy teenager!
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Nausea, Neuralgia, Neuropathy peripheral, Paraesthesia
Clinical narrative: She received the first GARDASIL injection on 4/23/2009. Symptoms began developing on 4/24/2009. Initially, she was only dizzy and nauseous. As time progressed she has become sicker. She began having headaches, back pain, chest pain, abdominal pain, muscle weakness, numbness and tingling to feet, nerve pain, near fainting, visual disturbances, back pain, muscle cramps, constant thirst, chronic fatigue. She has been diagnosed with peripheral neuropathy. There are over 15,000 VAERS reports regarding this vaccine and that is only current since April 30. And that number is not accurate. There are many, many more that have not made the connection of their illness being caused by the GARDASIL. How many girls need to be injured and killed by this vaccine before the FDA pulls it from the market? This is the organization that we depend upon to protect us - you have completely failed my once healthy daughter! She is now "one less" healthy teenager!
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Presyncope, Red blood cell sedimentation rate, Thirst, Thyroid function test, Visual impairment
Clinical narrative: She received the first GARDASIL injection on 4/23/2009. Symptoms began developing on 4/24/2009. Initially, she was only dizzy and nauseous. As time progressed she has become sicker. She began having headaches, back pain, chest pain, abdominal pain, muscle weakness, numbness and tingling to feet, nerve pain, near fainting, visual disturbances, back pain, muscle cramps, constant thirst, chronic fatigue. She has been diagnosed with peripheral neuropathy. There are over 15,000 VAERS reports regarding this vaccine and that is only current since April 30. And that number is not accurate. There are many, many more that have not made the connection of their illness being caused by the GARDASIL. How many girls need to be injured and killed by this vaccine before the FDA pulls it from the market? This is the organization that we depend upon to protect us - you have completely failed my once healthy daughter! She is now "one less" healthy teenager!
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vitamin B12
Clinical narrative: She received the first GARDASIL injection on 4/23/2009. Symptoms began developing on 4/24/2009. Initially, she was only dizzy and nauseous. As time progressed she has become sicker. She began having headaches, back pain, chest pain, abdominal pain, muscle weakness, numbness and tingling to feet, nerve pain, near fainting, visual disturbances, back pain, muscle cramps, constant thirst, chronic fatigue. She has been diagnosed with peripheral neuropathy. There are over 15,000 VAERS reports regarding this vaccine and that is only current since April 30. And that number is not accurate. There are many, many more that have not made the connection of their illness being caused by the GARDASIL. How many girls need to be injured and killed by this vaccine before the FDA pulls it from the market? This is the organization that we depend upon to protect us - you have completely failed my once healthy daughter! She is now "one less" healthy teenager!
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: The varicella vaccination administered to the patient has resulted in chickenpox.  At this time, I could not determine how severe the effect on a one year old kid. So far, he might have approximately have 125 bumps all over the body which does not seem like a mild case.
Age: 1.4
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure 3:38 am after vaccine admin previous day.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse concerning a "12 year old" female who was vaccinated with her 1st dose of GARDASIL, 0.5ml, IM.  The patient also received another 4 different vaccines (unspecified) and a few hours later the mother called and reported her daughter had a seizure.  The patient had sought medical attention.  The outcome was unknown.  Upon internal review, seizure was determined to be an other important medical event.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chest pain, Herpes zoster, Neuralgia, Pain
Clinical narrative: Information has been received from a 72 year old female, who on an unspecified date "couple of months ago", was vaccinated with a single dose of ZOSTAVAX (Merck).  After getting ZOSTAVAX (Merck) the patient experienced  shingles with complications.  She did not have blisters but experienced the nerve pain.  She visited multiple doctors before she was diagnosed.  In follow up received on 02-JUL-2009, the patient stated that she was hospitalized four times due to the severe chest pain that she was experiencing.  At no time, did she get a rash and felt that it made it harder for the physicians to diagnose her with shingles.  She had taken VALTREX and steroids but was still experiencing pain.  She stated it felt like "a hot blow torch on my stomach".  X-rays were performed (results not reported).  The patient was upset that she was not properly informed about the effectiveness of ZOSTAVAX (Merck) for her age group.  No further information is available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: Information has been received from a 72 year old female, who on an unspecified date "couple of months ago", was vaccinated with a single dose of ZOSTAVAX (Merck).  After getting ZOSTAVAX (Merck) the patient experienced  shingles with complications.  She did not have blisters but experienced the nerve pain.  She visited multiple doctors before she was diagnosed.  In follow up received on 02-JUL-2009, the patient stated that she was hospitalized four times due to the severe chest pain that she was experiencing.  At no time, did she get a rash and felt that it made it harder for the physicians to diagnose her with shingles.  She had taken VALTREX and steroids but was still experiencing pain.  She stated it felt like "a hot blow torch on my stomach".  X-rays were performed (results not reported).  The patient was upset that she was not properly informed about the effectiveness of ZOSTAVAX (Merck) for her age group.  No further information is available.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Information has been received from a physician concerning a 65 year old male patient with diabetes, gastrooesophageal reflux disease (GERD), allergies to IV contrast dye and a history of esophageal cancer surgery 6-8 months ago who on 23-JUN-2009 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (lot#663893/0128Y) subcutaneously in right arm.  Concomitant therapy included NEXIUM and an unspecified oral medication for diabetes.  On 04-JUL-2009, the patient experienced shingles like nerve pain on the left side of his body after receiving vaccine.  The patient was evaluated in an unspecified emergency room on 04-JUL-2009, diagnosed with "pre-shingles" and treated with an antiviral medication.  The patient was seen in a follow up visit with the physician on 06-JUL-2009.  The patient had no rash or lesions.  At the time of report, the patient did not recover.  Pre-shingles was considered to be disabling by the reporter.  Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Herpes zoster, Pain
Clinical narrative: Information has been received from an 89 year old female patient with arthritis who was vaccinated with ZOSTAVAX (Merck) one year ago approximately in July 2008. Concomitant therapy included CELEBREX. 6 months ago on approximately 06-JAN-2009 the patient developed a full blown shingles, her left butt was covered with shingles and it got up to vagina. The patient was bed ridden for 2 months because of the pain and she couldn't sit. She was healthy until she got the shingles. The patient had sought physician for medical attention and had not recovered. The patient's bed ridden for 2 months was considered to be disabling. No further information is available.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Chest discomfort, Dyspnoea, Urticaria
Clinical narrative: Anaphylaxis - Vaccine given @ 1:45 pt went home started @ 5:00 pm with hives then 7:00 pm chest tightness, SOB then went to ER. Pt went home from ER symptoms next day returned and is currently admitted to ER.  7/23/09 Received ER medical records of 7/9/09. FINAL DX: anaphylactic reaction Records reveal patient experienced malaise, scattered red hive rash, itching, facial swelling, abdominal pain & nausea, SOB, difficulty swallowing.  Had been seen in ER on 7/8 for same symptoms, tx w/Epi & d/c to home.  Symptoms recurred on 7/9 & epi pen had been given by parent prior to ER.  Tx w/IV antihistamine, steroids.   Stabilized & d/c to home.
Age: 0.73
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Computerised tomogram normal, Febrile convulsion, Otitis media acute, Pyrexia, White blood cell count increased
Clinical narrative: Immunizations followed about 4-5 hours by fever and febrile sz witnessed lasting about 10 10 min. Pt also with (L) otitis media. No sequelae.  10/20/09:  Hospital records and discharge summary received for dates of service 7/09/09 to 7/12/09. Dx:  Febrile seizure, cleared, left otitis media, improved. Assessment:  Presented to ER after 10 to 15 minute seizure with rhythmic clenching and relaxing in left arm and leg, initially alert then became lethargic and unresponsive.  Eyes jerked and jerking motions were noted in both arms and both legs.  Febrile upon admission to ER with left otitis media and leukocytosis.  Started on IV Rocephin, Tylenol and Motrin then switched to oral Omnicef. Child has had mild cough and runny nose over last 2-3 days.  Chest X-Ray clear, CT of head was normal.  At the time of discharge patient was active, alert, taking feedings and medications well and was afebrile.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: patient developed approx 12 raised blistered. very puritic. no treatment necessary.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Pruritus
Clinical narrative: Immunization given on 6/30/09. Parent called 7/01/09 to report child had no problems on 6/30/09 but when he awakened on 7/01/09 he complained of itching to back of neck and hairline X 1 hr. No other symptoms. Parent called Peditrician and the doctor told her to call us to report symptoms and fill out VAERS.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Nausea, Retching
Clinical narrative: Patient feeling nausea and dry heaves in beginning, then dizzy and diaphoretic. Mat brought in and patient assisted to floor and blood pressure taken 100/70 pulse 62. After 5 minutes Client states "I am feeling better" Blood pressure 100/70. Client up to sitting postion and not diaphoretic anymore. Client up in chair drinking and eating granola bar and juice. Client to sit for 10 minutes before leaving.
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed a bright red, irregular shaped, warm, slightly itchy, bumpy, firm and slightly raised area around her second Varicella vaccine, about 2 in X 1 inch. I called the nurse on call, since it was 2230 at night when my daughter discovered the area--2 days after the vaccine was given.  She suggested we mix up a solution of 1 quart warm water and 2 Tbsp salt.  Soak a washcloth in the solution and apply it to the irritated area for 15 min. then apply an antibiotic ointment.  We did this and by morning, the site did look better.  The mark was a pink color, but still present.  We followed up with Dr. that morning who said we were doing the right things since the site was looking better.  It is now the 4th day after the vaccine and the mark is still present but light pink and not as firm. We continue to put the salt water solution and antibiotic ointment on twice a day.  She also complained of a stuffy nose at the onset of the inflammed area.
Age: 15.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Nasal congestion
Clinical narrative: Patient developed a bright red, irregular shaped, warm, slightly itchy, bumpy, firm and slightly raised area around her second Varicella vaccine, about 2 in X 1 inch. I called the nurse on call, since it was 2230 at night when my daughter discovered the area--2 days after the vaccine was given.  She suggested we mix up a solution of 1 quart warm water and 2 Tbsp salt.  Soak a washcloth in the solution and apply it to the irritated area for 15 min. then apply an antibiotic ointment.  We did this and by morning, the site did look better.  The mark was a pink color, but still present.  We followed up with Dr. that morning who said we were doing the right things since the site was looking better.  It is now the 4th day after the vaccine and the mark is still present but light pink and not as firm. We continue to put the salt water solution and antibiotic ointment on twice a day.  She also complained of a stuffy nose at the onset of the inflammed area.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Burning sensation, Headache, Myalgia, Nausea
Clinical narrative: extreme burning & itching, extensive swelling elbow to neck, pounding headache, muscle pain, joint pain, low fever, nauseous.  Treatment:  tylenol, benedryl, ice, naproxen. symptoms subsided somewhat after 3 days. at 5 days can use arm.  At 7 days still headache and itching, continue with tylenol, applying Lanacane As of this date, 8/24/09, the injection site continues to throb and is painful to the touch.  I also continue to have muscle cramping and headaches.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pruritus, Pyrexia
Clinical narrative: extreme burning & itching, extensive swelling elbow to neck, pounding headache, muscle pain, joint pain, low fever, nauseous.  Treatment:  tylenol, benedryl, ice, naproxen. symptoms subsided somewhat after 3 days. at 5 days can use arm.  At 7 days still headache and itching, continue with tylenol, applying Lanacane As of this date, 8/24/09, the injection site continues to throb and is painful to the touch.  I also continue to have muscle cramping and headaches.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: soreness, redness and swelling left arm ~ 12 hrs after receiving pneumovax     taking Motrin with effect
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: SORENESS AND SWELLING, SLIGHT REDNESS LEFT ARM FROM ELBOW TO SHOULDER ~12 HRS AFTER RECEIVING PNEUMOVAX         IBUPROFEN AND COOL COMPRESS RECOMMENDED, CALL md IF SXS WORSEN
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cold sweat, Fall, Head injury, Nausea, Unresponsive to stimuli
Clinical narrative: After vaccine administration the pt was standing waiting w. his mother for the vaccine record, he fall backward hit the wall w. his head and slide down the wall, he was no immediately responsive, but in a few secs he resonded to his name, pt was clammy and nauseated, pt assessed by Dr, pt stayed about another 15 mins until he felt better. Pt had not eaten breakfast that am only had a granola bar. Pt had requested the injections in his thighs becaue he had a swim meet the next morning.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Gaze palsy, Musculoskeletal stiffness, Screaming, Unresponsive to stimuli
Clinical narrative: Patient rec'd vaccines 7/8/09 and on 7/9/09 had an event that starting with high pitched scream then patient went stiff and eyes rolled back and remained stiff and unresponsive for 5-10 minutes.
Age: 26.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Dermatitis, Muscular weakness, Musculoskeletal pain, Skin exfoliation
Clinical narrative: Diffuse Musculostreleted pain and weakness. Skin desquamation @ fingers; Dermatitis @ head.  7/23/09 Received hospital medical records for 7/4-7/10/2009. FINAL DX: myalgias & muscle stiffness, etiology unknown, possible reaction to anthrax vaccine or Augmentin, possible stiff person syndrome; small splenic infarcts, unkown cause, nonalcoholic hepatic steatosis w/bridging fibrosis. Records reveal patient had several recent illnesses w/hospitalizations.  Initial symptoms had occurred approx 2 weeks s/p anthrax vaccine having flu-like symptoms of fever, myalgias, arthralgias, swelling of right submandibular area, SOB & pleuritic chest pain.  Ttx w/Augmentinfor presumed salivary gland infection, initially improved then worsened.  Admitted to outlying hospital for approx 2 wks w/extensive w/u which revealed pulmonary effusions & splenic infarcts all thought to be related to Augmentin allergy.  Tx w/IV antibiotics & antivirals & improved. D/C on 7/1 w/o clear diagnosis.   After d/c, patient developed fever, chills, fatigue, diffuse musculoskeletal pain, stiffness & weakness, difficulty walking, peeling skin on fingers, continued vesicular itchy scalp rash, loss of appetite, 20# weight loss in 2 weeks, diarrhea x 3 wks while on antibiotics, icteric.  ID & Derm consults done.  Exam revealed scalp & fingernail rash.  Proximal more than distal muscle weakness.  C. diff tx w/oral antibiotic.  Splenic infarcts tx w/anticoagulant therapy.  Remained stable but still symptomatic at d/c to home w/PCP, Neuro & Hepatology referrals.  10/13/09 Received hospital medical records and discharge summary for dates of service 6/22/09-7/1/09.  Dx:  Acute febrile illness of unknown cause associated with sialadenitis, diffuse pulmonary infiltrates with hypoxia, elevated liver function tests, thrombocytopenia.  Possible atypical viral infection.  Possible adverse drug reaction to clavulanic acid. Possible adverse reaction to anthrax vaccine.  Possible bilateral lower lobe pulmonary emboli.  Small splenic infarctions of undetermined cause.  Assessment:  Pt. developed swollen submandibular gland or lymph node 4 days prior to admission with fevers to 102 degrees.  He was treated with Augmentin by his PCP and initially improved for 2 days, then developed recurrent high fever.  In the ED he was tachypnic and tachycardic, with an O2 sat of 89% on room air, hypoxemia.  Given supplemental O2.  Leukocytosis, anemia and thrombocytopenia present at admission.  The pts. main symptoms were breathlessness and pleuritic chest pain over the course of the hospitalization. Treated with low molecular weight heparin and started on warfarin for pulmonary emboli. Patient discharged home in a stable, weakened condition.  ICD 9 Codes:  780.60, 415.19, 584.9, 527.2, 289.59, 287.5, 511.9, 571.8, 401.9, 518.0, 053.9, 780.6.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Heart rate decreased, Hyperhidrosis, Hypoventilation, Immediate post-injection reaction
Clinical narrative: 2:53 P.M. 18 y.o w/m administered a Tdap IM:(lt)Deltoid (Boostrix)Glaxo-Smith-Kline:lot Number AC52B039BA Immediately after injection pt. became dizzy, diaphoretic,(sweating profusely)and breathing slow and shallow as to be holding his breath. 2:54: RN BSN summoned RN MSN Nurse Manager to come to clinic room next door. Upon arrival pt. was sweating profusely head to toe: (soaking wet.) Pt. visually assessed.2:55 p.m. B/P 92/42 left arm pulse 44- reg. resp: 16. Pt. still sitting in chair. 911 EMS called.  3:00 P.M Pt. placed in trendelenburg position on the floor, B/p 112/70, pulse 45- reg. resp. 24.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Respiratory rate decreased
Clinical narrative: 2:53 P.M. 18 y.o w/m administered a Tdap IM:(lt)Deltoid (Boostrix)Glaxo-Smith-Kline:lot Number AC52B039BA Immediately after injection pt. became dizzy, diaphoretic,(sweating profusely)and breathing slow and shallow as to be holding his breath. 2:54: RN BSN summoned RN MSN Nurse Manager to come to clinic room next door. Upon arrival pt. was sweating profusely head to toe: (soaking wet.) Pt. visually assessed.2:55 p.m. B/P 92/42 left arm pulse 44- reg. resp: 16. Pt. still sitting in chair. 911 EMS called.  3:00 P.M Pt. placed in trendelenburg position on the floor, B/p 112/70, pulse 45- reg. resp. 24.
Age: 1.0
Sex: M
Vaccine: HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Vaccination error
Clinical narrative: Spoke with Mother who has noticed no difference in the childs behavior or in the injection site. Informed mom of error and told her that she might notice more redness at the site and child may be more drowsy than normal. Mom hasn't noticed either of those at this time. I told the mom not to hesitate to call if she notices anything.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Injection site inflammation
Clinical narrative: Inflamation around the smallpox site. With a diameter of 8cm. With No fever, No chills, No chest pain, No nausea, No vomting, No night sweats, No headaches, Pt admits on scratching around the wound site and tapping it.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Diarrhoea, Gastritis, Rotavirus test, Stool analysis
Clinical narrative: Diarrhea 4 days after Rotateq (6/26/09). Change in formula before vaccine to Prosobee. Seen for gastritis 6/30/09-diarrea x 3d.
Age: 56.0
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented with redness, warmth, swelling and pain of right arm surrounding injection site in area measuring 12 cm x 7 cm. Treated for possible development of cellulitis with Keflex 500mg PO TID x 10 days, prednisone 60mg daily x 5 days, and zyrtec 10mg daily until inflammation subsided.
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Respiratory tract congestion
Clinical narrative: The second evening after patient received the Varicella vaccine, my husband called me at work to tell me patient told him to look at his arm because it itched.  My husband, noticed a large, bright red, raised, bumpy, warm, irregular shaped reaction around the vaccination site.  This reaction sounded very similar to my daughters reaction just after she received her second varicella vaccination 2 days prior to my son receiving his, only my sons was larger--about 4 in X 3 in.  My husband treated it the same way we were told to treat my daughters reaction.  He mixed 1 quart of warm salt water with 2 Tbsp salt, soaked a washcloth in the solution and applied it for 15 minutes, then applied an antibiotic ointment.  When I got home that morning, my husband noted it did not look as red, but I could see it was raised, dark pink in the middle, white around the edges, bumpy towards the center and warm to the touch.  My son said it did not itch anymore or hurt. We continued to treat it with the solution and antibiotic ointment twice a day.  This evening it looks slightly less red and warm, but is still swollen, bumpy and looks as if there was a reation.  We contacted Dr. to alert her of patient's reaction since we had taked his sister in for the same reason, just the day before.  We will continue to monitor the site, treat as we stated earlier and pray for its total resolvement.
Age: 37.0
Sex: M
Vaccine: ANTH, TDAP
Symptoms: Asthenia, Back pain, Fatigue, Gait disturbance, Influenza like illness
Clinical narrative: Received AVA #3 and Tdap on 6/29/09 as routine vac update. (He denied any recent or current URI symptoms.) That evening he noted onset of fatigue, generalized body aches, left arm pain and tenderness (at vac sites). He also c/o night sweats with his wife reporting he was moaning and seemed restless. Pt awoke fatigued, reported to work noting increased pain, swelling, redness to left deltoid/upper arm, and generalized body aches to knees, hips, back, with "flu like s/s". He denied any rhinorrhea, congestion, sore throat, HA, fever, n/v/d, sob, cp, paresthesia, or rashes. He took TYLENOL ES and MOTRIN 800 mg with minimal relief of s/s (muscle/body aches). Later that day (Tues) he was unable to move Left arm due to pain with no restriction to grip and no paresthesia. His pain was 10/10 unrelieved with meds resulting in a poor nights sleep. His s/s continued thru Wed with easing of pain, decrease in swelling, redness, and generalized body discomforts with use of MOTRIN 800 mg BID. He did note a "stumbling gait" Wed morning reporting no energy to get out of bed or walk. He denied any further gait disturbance since. He also c/o fatigue since receipt of above 2 vaccinations Monday: had difficult time sleeping. Pt reports feeling exhausted and required naps after 8 hours work Tuesday. He complained of a poor nights sleep Tues evening; however was less fatigued Wed not requiring a nap but still tired. He had been taking MOTRIN for pain/swelling which did allow him to sleep Wed night. He reported feeling better today (Thursday 7/2/09) with fatigue level now 1-2/10 from 10/10 a few days ago. 7/2/2009 evaluation noted left deltoid/upper arm with 2 well healing puncture marks to central deltoid region (pt stated AVA was anterior w/Tdap site posterior). There is at 0.5 inch circular erythema surrounding each puncture site with extending "reversed L" shaped erythema extending down the left upper arm then anteriorly (5 inch height vs 1-3 inch width.) Left arm circumference is 15.5 inches with right arm 14.5 inches. Pt is right handed. No axillary lymphadenopathy, no pain to shoulder girdle or left elbow with palpation. Erythemic area's area warm to touch. Musculoskeletal system was intact with c/o pain with shoulder at 90 angle but could push thru and extend arm upright over head. Full ROM right shoulder w/o limitations and to neck. Grips left = right with no weakness or sensory loss. Cap refill <2 sec bilaterally. Skin warm and dry. Radial, brachial pulses = bilaterally regular rate and rhythms 76.
Age: 37.0
Sex: M
Vaccine: ANTH, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth, Moaning
Clinical narrative: Received AVA #3 and Tdap on 6/29/09 as routine vac update. (He denied any recent or current URI symptoms.) That evening he noted onset of fatigue, generalized body aches, left arm pain and tenderness (at vac sites). He also c/o night sweats with his wife reporting he was moaning and seemed restless. Pt awoke fatigued, reported to work noting increased pain, swelling, redness to left deltoid/upper arm, and generalized body aches to knees, hips, back, with "flu like s/s". He denied any rhinorrhea, congestion, sore throat, HA, fever, n/v/d, sob, cp, paresthesia, or rashes. He took TYLENOL ES and MOTRIN 800 mg with minimal relief of s/s (muscle/body aches). Later that day (Tues) he was unable to move Left arm due to pain with no restriction to grip and no paresthesia. His pain was 10/10 unrelieved with meds resulting in a poor nights sleep. His s/s continued thru Wed with easing of pain, decrease in swelling, redness, and generalized body discomforts with use of MOTRIN 800 mg BID. He did note a "stumbling gait" Wed morning reporting no energy to get out of bed or walk. He denied any further gait disturbance since. He also c/o fatigue since receipt of above 2 vaccinations Monday: had difficult time sleeping. Pt reports feeling exhausted and required naps after 8 hours work Tuesday. He complained of a poor nights sleep Tues evening; however was less fatigued Wed not requiring a nap but still tired. He had been taking MOTRIN for pain/swelling which did allow him to sleep Wed night. He reported feeling better today (Thursday 7/2/09) with fatigue level now 1-2/10 from 10/10 a few days ago. 7/2/2009 evaluation noted left deltoid/upper arm with 2 well healing puncture marks to central deltoid region (pt stated AVA was anterior w/Tdap site posterior). There is at 0.5 inch circular erythema surrounding each puncture site with extending "reversed L" shaped erythema extending down the left upper arm then anteriorly (5 inch height vs 1-3 inch width.) Left arm circumference is 15.5 inches with right arm 14.5 inches. Pt is right handed. No axillary lymphadenopathy, no pain to shoulder girdle or left elbow with palpation. Erythemic area's area warm to touch. Musculoskeletal system was intact with c/o pain with shoulder at 90 angle but could push thru and extend arm upright over head. Full ROM right shoulder w/o limitations and to neck. Grips left = right with no weakness or sensory loss. Cap refill <2 sec bilaterally. Skin warm and dry. Radial, brachial pulses = bilaterally regular rate and rhythms 76.
Age: 37.0
Sex: M
Vaccine: ANTH, TDAP
Symptoms: Myalgia, Night sweats, Pain, Poor quality sleep, Restlessness
Clinical narrative: Received AVA #3 and Tdap on 6/29/09 as routine vac update. (He denied any recent or current URI symptoms.) That evening he noted onset of fatigue, generalized body aches, left arm pain and tenderness (at vac sites). He also c/o night sweats with his wife reporting he was moaning and seemed restless. Pt awoke fatigued, reported to work noting increased pain, swelling, redness to left deltoid/upper arm, and generalized body aches to knees, hips, back, with "flu like s/s". He denied any rhinorrhea, congestion, sore throat, HA, fever, n/v/d, sob, cp, paresthesia, or rashes. He took TYLENOL ES and MOTRIN 800 mg with minimal relief of s/s (muscle/body aches). Later that day (Tues) he was unable to move Left arm due to pain with no restriction to grip and no paresthesia. His pain was 10/10 unrelieved with meds resulting in a poor nights sleep. His s/s continued thru Wed with easing of pain, decrease in swelling, redness, and generalized body discomforts with use of MOTRIN 800 mg BID. He did note a "stumbling gait" Wed morning reporting no energy to get out of bed or walk. He denied any further gait disturbance since. He also c/o fatigue since receipt of above 2 vaccinations Monday: had difficult time sleeping. Pt reports feeling exhausted and required naps after 8 hours work Tuesday. He complained of a poor nights sleep Tues evening; however was less fatigued Wed not requiring a nap but still tired. He had been taking MOTRIN for pain/swelling which did allow him to sleep Wed night. He reported feeling better today (Thursday 7/2/09) with fatigue level now 1-2/10 from 10/10 a few days ago. 7/2/2009 evaluation noted left deltoid/upper arm with 2 well healing puncture marks to central deltoid region (pt stated AVA was anterior w/Tdap site posterior). There is at 0.5 inch circular erythema surrounding each puncture site with extending "reversed L" shaped erythema extending down the left upper arm then anteriorly (5 inch height vs 1-3 inch width.) Left arm circumference is 15.5 inches with right arm 14.5 inches. Pt is right handed. No axillary lymphadenopathy, no pain to shoulder girdle or left elbow with palpation. Erythemic area's area warm to touch. Musculoskeletal system was intact with c/o pain with shoulder at 90 angle but could push thru and extend arm upright over head. Full ROM right shoulder w/o limitations and to neck. Grips left = right with no weakness or sensory loss. Cap refill <2 sec bilaterally. Skin warm and dry. Radial, brachial pulses = bilaterally regular rate and rhythms 76.
Age: 19.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: No adverse event/pregnancy outcome report of vaccines inadvertently administered during pregnancy AVA and TYPHOID VICPs administered on 14 Aug 2008.  EDC: 24 April 200 Pregnancy Outcome: Delivery Date: 4/26/09 healthy infant girl, APGARS 8/9, birth weight 3065 See supplemental information for AVA in pregnancy (attached)
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Aphthous stomatitis, Bacterial culture, Virus culture
Clinical narrative: Received 2m vaccination with oral Rotavirus on 6/30/09. Aphthous ulcer - onset  5 days after ROTATEQ.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: 4 hours after receiving vaccine pt c/o H/A dizziness and nausea that lasted 5 hours.