chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described an adult subject of unspecified gender who had a decreased response to vaccination with hepatitis B vaccine, manufacturer unspecified) for prophylaxis. On an unspecified date several years before 9/20/2005, the subject received a dose of hepatitis B vaccine, dose number not provided. several years later on or before 9/2/2005, a hepatitis B surface antibody titer was less than 3 mIU/ml.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described an adult subject of unspecified gender who had a decreased response to vaccination with hepatitis B vaccine, manufacture unspecified for prophylaxis. On an unspecified date several years before Sept 2 2005, the subject received a dose of hepatitis B vaccine, dose number not provided. Several years later, on or before 9/2/2005, a hepatitis B surface antibody titer was less than 4 mIU/ml.
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: This case was reported by a physician and described the occurrence of sore arm in an adult female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. On 8/08/2005 the subject received the 1st dose of Engerix B (Lot number not specified) 20 mcg, to an unspecified arm. On the same day as vaccination with Engerix B, the subject experienced a sore arm. At the time of reporting, on 9/07/2005, the event was unresolved.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a nurse and described the occurrence of rash in a 60 year old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. On 08/29/2005 the subject received 1st dose of Engerix B in the left arm (lot AHBVB135AB). On Sept 4 2005, 6 days after vaccination with Engerix B, the subject experienced a body rash. The subject was seen at a physicians office. The vaccination course with Engerix B was discontinued. The body rash resolved on 9/7/2005. The nurse considered the body rash to possibly be related to vaccination with Engerix B.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacist and described an adult subject of unspecified gender who did not respond to the hepatitis B vaccine recombinant Engerix B, immunization series. The pharmacist reported that two individuals are non responders to the Engerix B series, however, subject identifiers were not provided. On an unspecified date before 9/12/2005, the subject received a dose of Engerix B (dose number not provided). At an unspecified time following the administration of Engerix B, on an unspecified date on or before Sept 12 2005, a hepatitis B surface antibody titer was negative.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis
Clinical narrative: This case was reported by a physician and described an adult subject of unspecified gender who did not respond to vaccination with hepatitis B vaccine recombinant (Engerix B). On an unspecified date before 9/23/2005, the subject completed the first series of Engerix B. At an unspecified time following the completion of the first series of Engerix B, on an unspecified date before 9/23/2005, a hepatitis B surface antibody titer was negative. On an unspecified date before 9/23/2005, the second series of Engerix B was completed. At an unspecified time following receipt of the 6 dose of Engerix B, on an unspecified date on or before 9/23/2005, a hepatitis B surface antibody titer was negative.
Sex: U
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergy attack possibly due to latex in a subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine recombinant for prophylaxis.  The healthcare professional reported that, some subjects experienced an allergy attack possibly due to latex following the receipt of Engerix-B, however, subject identifiers were not provided.   The healthcare professional reported that the subject, had previously been established as being allergic to latex before the vaccine was administered. On an unspecified date on or before 09/26/2005, the subject received a dose of Engerix-B, in the 20 mcg, single-dose prefilled syringe.  The outcome of the allergic reaction was not reported.  The healthcare professional considered the allergic reaction to probably be related to vaccination with Engerix-B.
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of numbness in a female subject aged between 40 and 49 years old who was vaccinated with Hepatitis B vaccine for prophylaxis.  The reporting healthcare professional is the subject.   On an unspecified date years ago, the subject received 1st dose of Engerix B.  At an unspecified time after vaccination with Engerix-B, the subject experienced numbness of the hand and other areas, and hand tingling.  At an unspecified time later, the events resolved.  On an unspecified date later, the subject received the second dose of Engerix-B and the events reocurred.  At the time of reporting the events were resolved.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 33 year old male subject who did not respond to immunization to the hepatitis B vaccine recombinant immunization series.  There were no concurrent medications.   On 02/08/2005 the subject received the 1st dose of Engerix-B.  On 03/17/2005 the subject received the 2nd dose of Engerix-B.  On 08/09/2005, the subject received the 3rd dose of Engerix-B.  On 09/16/2005, a hepatitis B surface antibody titer was less than 2 mIU/ml.
Sex: U
Vaccine: HEP
Symptoms: Pain
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of injection site stinging in an adult subject of unspecified gender who was vaccinated with hepatitis B vaccine recombinant for prophylaxis.  The nurse reported to the sales representative that, "85 percent of the subjects that received Engerix-B from the pre-filled syringe have complained of stinging at the injection site," however, subject identifiers were not provided. On an unspecified date on or after "mid" September 2005 and on or before 10/12/2005, the subject received unspecified dose of Engerix-B.  At an unspecified time following the administration of Engerix-B, on an unspecified date on or after "mid" September 2005 and on or before 10/12/2005, less than one month after vaccination with Engerix-B, the subject experienced injection site stinging.  The outcome of the injection site stinging was not reported.  The nurse reported to the sales representative that she, "is hearing more complaints of injection site stinging with Engerix-B prefilled syringes.  The office switched over to the Engerix-B prefilled syringe in mid September 2005."  The nurse also reported that the office, "also has hepatitis A inactivated and hepatitis B recombinant vaccine prefilled syringes but are not hearing any complaints of stinging with those."
Sex: F
Vaccine: HEP
Symptoms: Injection site swelling, Rash erythematous
Clinical narrative: This case was reported by a nurse and described the occurrence of red rash on arm in a female subject aged between 30 and 39 years old who was vaccinated with hepatitis B vaccine recombinant for prophylaxis.  The nurse reported that the subject has no known allergies.  On 10/10/2005 the subject received 2nd dose of Engerix-B in her right arm.  On 10/18/20005, 8 days after vaccination with Engerix-B, the subject experienced a red rash around the injection site and on the other arm as well.  The subject was seen at a physician's office.  At the time of initial reporting, 10/19/2005, the events were ongoing.
Sex: M
Vaccine: HEP
Symptoms: Pain
Clinical narrative: This case was reported by a nurse and described the occurrence of sore arm in an adult male subject who was vaccinated with hepatitis B vaccine recombinant for prophylaxis.   On 10/07/2005 the subject received 3rd dose of Engerix-B in the arm.  At an unspecified time following the 3rd dose of Engerix-B, on or after 10/07/2005 and on or before 10/21/2005, the subject experienced soreness in the arm.  At the time of initial reporting, 10/21/2005, the arm soreness was ongoing.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described a subject of unspecified age and gender who tested positive for hepatitis B surface antigen following vaccination with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. On an unspecified date before Oct 20 2005, the subject received a dose of Engerix B (dose number and lot number not provided). Approximately tow to three weeks after vaccination with Engerix B, on an unspecified date on or before Oct 20 2005, the subject tested positive for hepatitis B surface antigen. The outcome of the event was not reported.
Sex: M
Vaccine: HEP
Symptoms: Arthralgia
Clinical narrative: This case was reported by a nurse and described the occurrence of bilateral knee pain in an adult male subject who was vaccinated with hepatitis B vaccine recombinant Engerix B for prophylaxis. On 10/20/2005 the subject received 1st dose of Engerix B (lot AHBVB004BA. On 10/20/2005, less than one day after vaccination with Engerix B, the subject experienced bilateral knee pain. The outcome of the bilateral knee pain was not reported.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Medication error
Clinical narrative: This case was reported by a nurse and described a 54 year old male subject who did not respond to immunization with hepatitis B vaccine recombinant Engerix B for prophylaxis. The subjects medical history included hypertension, asthma and social alcohol consumption. On 11/10/2004 the subject received 1st dose of Engerix B. On 12/10/2005, the subject received 2nd dose of Engerix B. On 6/8/2005, the subject received 3rd dose of Engerix B (lot AHBVB125AA). The represents an interval of seven months between the 1st and 3rd doses of Engerix B which is longer than the recommended interval of six months between the 1st and 3rd doses. On 08/24/2005, 77 days after vaccination with the 3rd dose of Engerix B, a hepatitis B surface antibody titer was negative. The nurse considered the negative antibody titer to possibly be related to vaccination with Engerix B.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a subject of unspecified age and gender who did not respond to immunization to hepatitis B vaccine recombinant (Engerix B) for prophylaxis. On an unspecified date on  or before 9/27/2005, the subject received a dose of Engerix B. The dose number was nor provided, however, the nurse reported that, the patient received a series of Engerix B. At an unspecified time following the last dose of the Engerix B series, the nurse reported that, the patient failed to seroconvert. The subject was seen at a physicians office. Report received via manufacturer. Follow up will not be available.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Dysgeusia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse and described the occurrence of taste abnormality in a 34 year old male subject who was vaccinated with hepatitis B vaccine recombinant Engerix B. Medical history included smoker, allergy to prednisone, anaphylactic reaction bee sting, codeine allergy, Tequin allergy. On 9/7/2005 the subject received the 1st dose of Engerix B (lot AHBVB033BA0, the 1st dose of hepatitis A vaccine inactivated Havrix (lot AHAVB021AA) and a booster dose of tetanus toxoid. At an unspecified time following receipt of the immunizations, on 09/07/2005, the subject experienced a medicine taste in his mouth. The event resolved on an unspecified date on or after 9/7/2005 and before 11/1/2005. On 11/1/2005, the subject received a 2nd dose of Engerix B (lot AHBV171AA incorrect lot number). This is longer than the recommended interval of one month between the 1st and 2nd doses of Engerix B. Almost immediately following the administration of the 2nd dose of Engerix B, on 11/1/2005, the subject, again experienced a medicine taste that evolved to a rusty taste. The event resolved on 11/1/2005. The nurse considered the events to possibly be related to vaccination with Engerix B.
Age: 0.11
Sex: F
Vaccine: HEP
Symptoms: Hair disorder, Laboratory test abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of abnormal hair mercury level in a female subject born on 3/30/2004 who was vaccinated with hepatitis B vaccine Engerix B for prophylaxis. The subject received two doses of Engerix B vaccine, given on 04/08/2004 and 05/11/2004 respectively. At an unspecified time after vaccination with Engerix B, the subjects hair mercury level was abnormal. No one else in the subjects family had an elevated mercury level.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, erythema and swelling of L deltoid area about 24 hrs after vaccine administration in that area.  12.5 x 12.5 cm on 1/21/06.
Age: 1.02
Sex: M
Vaccine: FLU3, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Sudden infant death syndrome
Clinical narrative: My son died in his crib 5 days after his one year immunizations and flu shot without warning.
Age: 1.02
Sex: M
Vaccine: FLU3, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: My son died in his crib 5 days after his one year immunizations and flu shot without warning.
Age: 1.34
Sex: F
Vaccine: HIBV, MMR
Symptoms: Oral intake reduced, Pyrexia, Rash morbilliform, Sleep disorder
Clinical narrative: MMR admin. 01-10-06......Measles like rash over enter body 01-20-06......low grade fever....trip to hospital 01-21-06.....not eating normally...not sleeping normaly........emergency room suggested antihistamine if nessary.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea
Clinical narrative: Woke at 7 AM this morning with severe diarrhea.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Fever, Cellulitis
Age: 17.0
Sex: M
Vaccine: HEP, VARCEL, HEP, VARCEL
Symptoms: Coma, Convulsion, Cough, Dizziness, Loss of consciousness
Clinical narrative: Voiced fear of needles. Skin warm and dry, no resp. distress. Kept head down eyes closed until asked to open. No speech deficit. Stated felt "funny" Insisted on leaving HD. On way home according to LRMC. Pt's arm went stiff, had possible seizure, father called ambulance. Per LRMC, pt treated and released.
Age: 17.0
Sex: M
Vaccine: HEP, VARCEL, HEP, VARCEL
Symptoms: Musculoskeletal stiffness
Clinical narrative: Voiced fear of needles. Skin warm and dry, no resp. distress. Kept head down eyes closed until asked to open. No speech deficit. Stated felt "funny" Insisted on leaving HD. On way home according to LRMC. Pt's arm went stiff, had possible seizure, father called ambulance. Per LRMC, pt treated and released.
Age: 17.0
Sex: M
Vaccine: HEP, VARCEL, HEP, VARCEL
Symptoms: Convulsion, Malaise, Musculoskeletal stiffness
Clinical narrative: Voiced fear of needles. Skin warm and dry, no resp. distress. Kept head down eyes closed until asked to open. No speech deficit. Stated felt "funny" Insisted on leaving HD. On way home according to LRMC. Pt's arm went stiff, had possible seizure, father called ambulance. Per LRMC, pt treated and released.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Cyanosis
Clinical narrative: Initial report received on 17/Jan/2006 from a physician. A four month old male patient with a port wine stain (site not reported) and no history of seizure had received his second administration (route not reported) of ACTHIB, manufacturer, lot number UE782AA (Y0802-2) in the right thigh, a second administration (route and site not reported) of Pediarix, manufacturer lot number AC21B047AA and a second administration (route and site not reported) of Prevnar, manufacturer lot number A252969H, on 06/Jan/2006. Five days later, the patient experienced "bicycling of the lower extremities" and "wind milling of the arms." During this episode, the patient had difficulty breathing but was afebrile. Relevant diagnostic test performed was an MRI (date and result not reported). It was reported that the patient had received previous vaccines (vaccine information not reported) at two months of age. Per the reporter, it is unknown if the patient recover from these events at the time of this report.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Dyspnoea, Movement disorder
Clinical narrative: Initial report received on 17/Jan/2006 from a physician. A four month old male patient with a port wine stain (site not reported) and no history of seizure had received his second administration (route not reported) of ACTHIB, manufacturer, lot number UE782AA (Y0802-2) in the right thigh, a second administration (route and site not reported) of Pediarix, manufacturer lot number AC21B047AA and a second administration (route and site not reported) of Prevnar, manufacturer lot number A252969H, on 06/Jan/2006. Five days later, the patient experienced "bicycling of the lower extremities" and "wind milling of the arms." During this episode, the patient had difficulty breathing but was afebrile. Relevant diagnostic test performed was an MRI (date and result not reported). It was reported that the patient had received previous vaccines (vaccine information not reported) at two months of age. Per the reporter, it is unknown if the patient recover from these events at the time of this report.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal behaviour, Convulsion, Dyspnoea, Erythema, Skin discolouration
Clinical narrative: Initial report received on 17/Jan/2006 from a physician. A four month old male patient with a port wine stain (site not reported) and no history of seizure had received his second administration (route not reported) of ACTHIB, manufacturer, lot number UE782AA (Y0802-2) in the right thigh, a second administration (route and site not reported) of Pediarix, manufacturer lot number AC21B047AA and a second administration (route and site not reported) of Prevnar, manufacturer lot number A252969H, on 06/Jan/2006. Five days later, the patient experienced "bicycling of the lower extremities" and "wind milling of the arms." During this episode, the patient had difficulty breathing but was afebrile. Relevant diagnostic test performed was an MRI (date and result not reported). It was reported that the patient had received previous vaccines (vaccine information not reported) at two months of age. Per the reporter, it is unknown if the patient recover from these events at the time of this report.
Age: 0.2
Sex: M
Vaccine: DTAPH, IPV, PNC
Symptoms: Fontanelle bulging, Irritability, Meningitis, Pain, Pyrexia
Clinical narrative: By mom's report pt admitted to hospital 2 weeks after 2 mo 04/06/2005 and 4mo 06/01/2005 immunization. With high fever, fussy, aching, firm fontanelle, DX with viral meningitis both times. No Hib or PCV7 given with 3rd set.
Age: 0.2
Sex: M
Vaccine: DTAPH, IPV, PNC
Symptoms: Vaccine positive rechallenge
Clinical narrative: By mom's report pt admitted to hospital 2 weeks after 2 mo 04/06/2005 and 4mo 06/01/2005 immunization. With high fever, fussy, aching, firm fontanelle, DX with viral meningitis both times. No Hib or PCV7 given with 3rd set.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abdominal pain, Crying, Irritability, Screaming
Clinical narrative: Mother states high pitch dry for 2 days, very fussy, and never happened before according to mother. Dr diagnosed patient on 01/18/06 with abdominal colic, Dr didn't find any other abnormal findings on office visit.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Eye movement disorder, Loss of consciousness
Clinical narrative: After patient received vaccine 2 hours later in wal mart passed out x2, first time eyes rolled back in head, out for approx 1 min. Spouse states pt hadn't had anything to eat the night before and ate a huge buffet meal around 1:00 pm.
Age: 40.0
Sex: F
Vaccine: TYP, YF
Symptoms: Musculoskeletal stiffness, Myalgia, Neck pain, Pain
Clinical narrative: Started approx 50 hours after immunizations neck pain - sore to touch, hurts to turn head, stiff neck. 1/10/06 Pt saw MD, no treatment given.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Amnesia, Anaemia, Anxiety, Arthralgia
Clinical narrative: Insomnia, Anemia, dizziness, imbalance, nervousness, reflux, depression, anxiety, pain and abdominal cramps, arthritis, erectile dysfunction, loss of memory, pain and swelling on both knees and back, difficulty breathing, skin eruptions/rash, fungal infection on skin and feet. Medical records received from VA which reveal patient w/hx of low back pain, depression, anemia, left knee joint effusion, IBS, patellar tendinitis, left toen medial meniscus, GERD, overweight.  Received multiple rounds of PT w/o relief for back pain.  Old MRI showed L5-S1 degenerative disc disease w/bulging disc w/o radiculopathy.  Epidural blocks in 2004 provided temporary relief.  Has antalgic gait & uses single point cane.  Muscle spasms of the LS & TL spine regions.  Also being w/u for anemia to r/o hemoglobinopathy./ss
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Arthritis, Back pain, Balance disorder, Depression, Dizziness
Clinical narrative: Insomnia, Anemia, dizziness, imbalance, nervousness, reflux, depression, anxiety, pain and abdominal cramps, arthritis, erectile dysfunction, loss of memory, pain and swelling on both knees and back, difficulty breathing, skin eruptions/rash, fungal infection on skin and feet. Medical records received from VA which reveal patient w/hx of low back pain, depression, anemia, left knee joint effusion, IBS, patellar tendinitis, left toen medial meniscus, GERD, overweight.  Received multiple rounds of PT w/o relief for back pain.  Old MRI showed L5-S1 degenerative disc disease w/bulging disc w/o radiculopathy.  Epidural blocks in 2004 provided temporary relief.  Has antalgic gait & uses single point cane.  Muscle spasms of the LS & TL spine regions.  Also being w/u for anemia to r/o hemoglobinopathy./ss
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Dyspnoea, Erectile dysfunction, Fungal infection, Gastrooesophageal reflux disease, Insomnia
Clinical narrative: Insomnia, Anemia, dizziness, imbalance, nervousness, reflux, depression, anxiety, pain and abdominal cramps, arthritis, erectile dysfunction, loss of memory, pain and swelling on both knees and back, difficulty breathing, skin eruptions/rash, fungal infection on skin and feet. Medical records received from VA which reveal patient w/hx of low back pain, depression, anemia, left knee joint effusion, IBS, patellar tendinitis, left toen medial meniscus, GERD, overweight.  Received multiple rounds of PT w/o relief for back pain.  Old MRI showed L5-S1 degenerative disc disease w/bulging disc w/o radiculopathy.  Epidural blocks in 2004 provided temporary relief.  Has antalgic gait & uses single point cane.  Muscle spasms of the LS & TL spine regions.  Also being w/u for anemia to r/o hemoglobinopathy./ss
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Nervousness, Oedema, Pain, Rash, Skin disorder
Clinical narrative: Insomnia, Anemia, dizziness, imbalance, nervousness, reflux, depression, anxiety, pain and abdominal cramps, arthritis, erectile dysfunction, loss of memory, pain and swelling on both knees and back, difficulty breathing, skin eruptions/rash, fungal infection on skin and feet. Medical records received from VA which reveal patient w/hx of low back pain, depression, anemia, left knee joint effusion, IBS, patellar tendinitis, left toen medial meniscus, GERD, overweight.  Received multiple rounds of PT w/o relief for back pain.  Old MRI showed L5-S1 degenerative disc disease w/bulging disc w/o radiculopathy.  Epidural blocks in 2004 provided temporary relief.  Has antalgic gait & uses single point cane.  Muscle spasms of the LS & TL spine regions.  Also being w/u for anemia to r/o hemoglobinopathy./ss
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Movement disorder, Pain, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 46 year old female who on 09-Jan-2006 was vaccinated intramuscularly in the right arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). Later that same day on 09-Jan-2006, the patient developed redness, pain, swelling, and hardness to her right arm. On 10-Jan-2006, the patient contracted the office to report the symptoms and that she could not lift her right arm. The physician started the patient on therapy with prednisone 50 mg. The nurse confirmed that the patient received no other treatment. At the time of this report, the patient had not contacted the office again, and it was unknown if the patient had recovered. The patient's redness, pain, swelling and hardness of her right arm, and decreased mobility of right arm were considered to be disabling and other medical events (OMIC). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer, who is also the mother of a four year old son who was vaccinated with measles vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live and then developed "PPD, mild autism with a high IQ" after being vaccinated. The mother did not provide any further information regarding the event, because she didn't feel that her son's experience is related to vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. There was no product quality complaint reported. The patient sought unspecified medical attention. Upon internal review PPD, mild autism has been determined to be another important medical event (OMIC). Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning an adult female who was vaccinated with two doses of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live as a child. Subsequently, during prenatal screening, the patient was found to have a negative rubella antibody titer. Unspecified medical attention was sought. No product quality complaint was involved. The reporter felt that the negative titer was another important medical event (OMIC). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMRV, PNC
Symptoms: Dermatitis bullous, Face oedema, Nasal oedema, Rash morbilliform
Clinical narrative: Information has been received from a registered nurse concerning her 12 month old granddaughter with no known allergies who in approximately December 2005, was vaccinated SC with a 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live. Concomitant vaccination included a dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine and a dose of pneumococcal 4 Lb 9V 14 1BC 19F 23F conj vaccine CCRM197) (Prevnar). Twelve days post-vaccination, sometime before 25-Dec-2005, the patient developed a chickenpox like rash on the face. Thirteen days post-vaccination, the patient developed a measle like rash. On the fourteenth, the patient was covered head to toe with a measles-like rash. The rash lasted for two weeks. The patient also experienced swelling of the face, nose and lips and was "medicated." Unspecified medical attention was sought and the patient was medicated for the swelling. Subsequently, the patient fully recovered. The patient had a family history of reactions to vaccines including her uncle who had an anaphylactic reaction to an unspecified vaccine and the reporter who has had "trouble" with unspecified vaccines. However, the patient's tow older sisters have had no problems with vaccinations. It was also noted that the patient's mother was four month's pregnant. A product quality complaint was not involved. The chicken-pox like rash, measles-like rash, and swelling of the face, nose and lips were determined to be other important medical events by the reporter (OMIC). Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Information has been received from a physician concerning an approximately 80 year old female with type II diabetes mellitus and asthma who on approximately 11/07/2005 was vaccinated SQ with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot # 649914/0578P). Concomitant therapy included an unspecified oral therapy. the physician reported that the patient had been previously vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (date unknown). Subsequently the patient developed redness, pain and swelling to the arm that was used for Pneumococcal 23v polysaccharide vaccination. Medical attention was sought and the patient received diphenhydramine hydrochloride (Benadryl) and prednisone. Subsequently, the patient recovered from redness, pain and swelling to the arm. The physician considered redness, pain and swelling to the arm to be other important medical events (OMIC). Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 45 year old female with type II diabetes mellitus who on approximately 11/07/2005 was vaccinated SQ with a dose of Pneumococcal 23v polysaccharide vaccine (lot #649914/0578P) and a dose of influenza virus vaccine (unspecified) into the opposite arm (unspecified). Concomitant therapy included an unspecified oral therapy. Subsequently the patient developed redness, pain and swelling to the arm that was used for the Pneumococcal 23v polysaccharide vaccine. Medical attention was sought and the patient received diphenhydramine hydrochloride (Benadryl) and prednisone. Subsequently, the patient recovered from redness, pain and swelling to the arm. The physician considered redness, pain and swelling to the arm to be other important medical events (OMIC). Additional information has been requested.
Age: 0.91
Sex: F
Vaccine: HIBV, IPV
Symptoms: Lethargy, Medication error
Clinical narrative: 4 days after immunization became lethargic and needed hospitalization. (may have been injection of Tenex). Per annual report- Ingestion of Tenex (Brother's medication).
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Swollen from shoulder to elbow- red and warm to touch. Encourage to apply cold compress and follow up with PMD.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Client received Fluzone on 11/5/05. On 11/7/05 she began itching on back and head, around waist. It became worse on 11/8/05. On 11/9/05 itching not as bad. Is taking Benadryl and a cream for itching.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Myositis
Clinical narrative: Profound myalgia upper extremities. Myositis. Several days after injection reaction at 6 wks post.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Pt come to VNA office 1/12 or 1/13 and said he still had soreness in right arm from pneumonia shot. He had been to see his doctor. His DR told him to get an x-ray first. Rx was dated 11/22/05. He still had not done so.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Rotator cuff syndrome
Clinical narrative: 6 weeks persistent left deltoid pain (injection site). Cannot exclude underlying rotator cuff syndrome. No visible/palpable exam findings.
Age: 15.0
Sex: F
Vaccine: FLU3, MNQ, PNC
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: PCV7 0.5 ml sub-q right arm given on 12/2//05. 12/30/05 at 16:00 received call fro mom. Inj. site red with 3 1/2" - 4" diameter. Temp 99.8. Advised ice pack and ibuprofen. Call on call physician if necessary.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV, TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On 1/10/06 pt received influenza and pneumococcal vaccine in the left deltoid area. Pt returned on 1/13/06 reporting increased swelling and redness in this area. DR. assessed pt placed on Augmentin 875 mg bid x8 days.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, PPV, FLUX, PPV, FLU3, MNQ, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pallor
Clinical narrative: Left arm 16 x 20 cm induration with edge of erythema central pallor, warmth administered 9:30 swelling by 5 pm follow day current description. Right arm 4 x 4.5 cm total erythema, swelling, warmth at sit of Menactra 24 hours later.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, PPV, FLUX, PPV, FLU3, MNQ, PPV
Symptoms: Dizziness, Erythema, Injection site oedema, Medication error, Nausea
Clinical narrative: Left arm 16 x 20 cm induration with edge of erythema central pallor, warmth administered 9:30 swelling by 5 pm follow day current description. Right arm 4 x 4.5 cm total erythema, swelling, warmth at sit of Menactra 24 hours later.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, PPV, FLUX, PPV, FLU3, MNQ, PPV
Symptoms: Erythema, Feeling hot, Injection site induration, Injection site inflammation, Injection site reaction
Clinical narrative: Left arm 16 x 20 cm induration with edge of erythema central pallor, warmth administered 9:30 swelling by 5 pm follow day current description. Right arm 4 x 4.5 cm total erythema, swelling, warmth at sit of Menactra 24 hours later.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, PPV, FLUX, PPV, FLU3, MNQ, PPV
Symptoms: Oedema peripheral, Swelling
Clinical narrative: Left arm 16 x 20 cm induration with edge of erythema central pallor, warmth administered 9:30 swelling by 5 pm follow day current description. Right arm 4 x 4.5 cm total erythema, swelling, warmth at sit of Menactra 24 hours later.
Age: 47.0
Sex: M
Vaccine: FLUN3
Symptoms: Anorexia, Ear pain, Fatigue, Headache, Insomnia
Clinical narrative: First day after receiving vaccine- tired. Second day - malaise, fever. Third day - headache, muscle aches, runny nose, chest congestion, ear pain, anorexia, insomnia.
Age: 47.0
Sex: M
Vaccine: FLUN3
Symptoms: Malaise, Myalgia, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: First day after receiving vaccine- tired. Second day - malaise, fever. Third day - headache, muscle aches, runny nose, chest congestion, ear pain, anorexia, insomnia.
Age: 41.0
Sex: M
Vaccine: FLUN3
Symptoms: Nasal congestion, Pain, Rhinorrhoea, Sneezing
Clinical narrative: Received FluMist on Thursday and by Friday afternoon had runny nose, sneezing and body aches. These symptoms lasted for 3 days after which the body aches subsides, but there was lingering stuffiness and runny nose for a couple of weeks.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Low BP (80/60), diaphoresis, lightheadedness, pallor. Orange juice and granola bar given. 10/31/05 12:05 pm influenza vaccine .5cc administered in left deltoid per standing order. Consent signed. Pt reports "I feel lightheaded," BP taken 80/60, diaphoresis and pallor noted. Pt alert and oriented, answering questions. Granola bar and orange juice given. Paramedics called. 10/31/05 12:10 pm report given to paramedics. Pt stated she gave blood (pleresis) earlier this AM. Pt still conscious drinking juice. State that she is embarrassed  and that paramedics not necessary. Pt states she feels better. Reassured pt paramedics is necessary and PHN wants to ensure that she is alright. 10/31/05 12:15 pm waiting with pt for paramedics. Pt sitting in chair, stable, conscious, answering questions. Pt states she feels lightheaded again and diaphoresing. Paramedics arrived. 10/31/05 12:20 pm Paramedics here. O2 given and VS taken. Pt taken to hospital. Will follow-up with VAERS and pt status. 11/1/05 4:30 pm T/C to pt home. Spoke to pt. Pt states that she is fine, was taken to hospital care ER and was evaluated and sent home stable. No follow up needed.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pruritus, Pyrexia
Clinical narrative: Client report generalized itching within the hour after receiving flu shot.  Took Benadryl.  Went to physician that evening-Temp 100 had swollen glands 11/13/05.
Age: 1.11
Sex: F
Vaccine: FLU3, HIBV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: rash over body developing on 1/8/06.  Flat red areas over body, face, scalp.  Per 1/19/06 TV with mom.  Rash lasted 5 days now gone.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills
Clinical narrative: Joint achiness and chills evening of vaccination.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Pain
Clinical narrative: General achiness, headache, dizziness.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Vomiting
Clinical narrative: Flu like symptoms and vomiting at 3AM.
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling
Clinical narrative: Right arm red, swollen about the size of two quarters.  Treat with cold compress and Tylenol for pain.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site reaction, Injection site swelling
Clinical narrative: Reaction of L deltoid to flu vaccine on 12-8-05. 6x4 cm pink and slight raised.  No temp.  No allergies to egg.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Feeling hot, Haemorrhage, Injection site reaction, Pain
Clinical narrative: Patient states received flu shot 12-14-05.  States nurse stated blood ran down arm.  Arm hurt that day and next day arm blue around injection site and remained for two weeks.  Patient noticed 1-7-06 that deltoid swollen and appeared bruised.  Patient states they were applying alcohol since injection received.  States arm is stinging and feels hot today.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Patient states received flu shot 12-14-05.  States nurse stated blood ran down arm.  Arm hurt that day and next day arm blue around injection site and remained for two weeks.  Patient noticed 1-7-06 that deltoid swollen and appeared bruised.  Patient states they were applying alcohol since injection received.  States arm is stinging and feels hot today.
Age: 24.0
Sex: F
Vaccine: MNQ, TD
Symptoms: Headache, Nasal congestion, Pain, Pain in jaw, Pyrexia
Clinical narrative: The night of receiving 2 immunizations complained of headache, stuffy nose, body aches, and jaw hurt.  Reports feeling feverish but has no thermometer.  Symptoms continued for at least 12 hours so patient called to report symptoms.  No local reaction noted.
Age: 1.65
Sex: F
Vaccine: DTAP, MMR
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Rash-fine/pink/ papular. Evanescent about 24 hours.  Fussy, low grade fever to 101.
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pyrexia, Swelling, Vaccination complication
Clinical narrative: Nurse gave Pneumovax vaccine that had expired on June 2005 to this patient.  In talking to the mother on 11/17/05 she reported that child had a red swollen L arm on 11/8/05.  Patient had fever(did not take).  Mom took child to Dr. who gave oral Benadryl and Tylenol.  Arm remained red and swollen on 11/9/05.  Child okay within two days and Benadryl and Tylenol.  MD to check with another MD about whether to repeat in light of local reaction and child condition. (Sickle cell disease)
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Nurse gave Pneumovax vaccine that had expired on June 2005 to this patient.  In talking to the mother on 11/17/05 she reported that child had a red swollen L arm on 11/8/05.  Patient had fever(did not take).  Mom took child to Dr. who gave oral Benadryl and Tylenol.  Arm remained red and swollen on 11/9/05.  Child okay within two days and Benadryl and Tylenol.  MD to check with another MD about whether to repeat in light of local reaction and child condition. (Sickle cell disease)
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Tenderness
Clinical narrative: Complained of tingling in and off and on since shot given on 10/26.  Area around where shot given still tender to touch and from side of elbow to hand still continues to "tingle" off and on.  Advised to see MD and let know outcome.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Redness, swelling, warmth of right upper extremity.  Started on Keflex 250mg TID for 10 days 1/20/06.
Age: 1.05
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Rash
Clinical narrative: "Bumps" noted on 1/13/06, became vesicular.  No other symptoms.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Arm swollen 2x's size and warm/red on 2nd day after immunizations.  Resolved slowly.
Age: 49.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Medication error
Clinical narrative: Patient was supposed to get Tdap but ended up with DTaP.  Patient has pain at injection site only.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Grey syndrome neonatal, Hypotonia, Pyrexia
Clinical narrative: Within several hours of receiving Pediarix, HIB and Prevnar developed fever to 101 and became limp and gray on mom's shoulder.  No choking. No seizure activity.  Not apneic.  Limp episode lasted about 30 minutes.  No CPR needed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Arteritis, Cellulitis
Clinical narrative: Left deltoid with progressive cellulitis.  Oral antibiotics started. Versus significant inflammatory response-nurse recall of struggle at time of immunization
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Injection site induration, Tenderness
Clinical narrative: Large area over front of thigh of redness, induration tenderness. Treatment with cold compresses, Benadryl, Tylenol for home therapy.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Patient called to report that he had swelling of his upper arm - the same arm the pneumonia shot was given.  Swelling subsided by PM 10/28.  No redness.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Erythema, Swelling
Clinical narrative: Developed a huge area of redness and swelling in the right thigh approximately 20 x 10cm in dimensions.  Resolved with Benadryl and warm compress after 4 days.
Age: 79.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Feeling hot, Oedema, Rash
Clinical narrative: Received pneumovax 01/10/2006 in left deltoid on 01/10/2006.  Developed redness, warmth, edema from site distally to hand.  Received Benadryl 25mg every 4 hours as needed and ice pack as desired.  Rash persisted thru 01/14/2006.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema peripheral, Rash, Skin discolouration
Clinical narrative: Onset of red warm swollen patch on left arm below DTAP and IPV immunization sites within 24 hours.  Rash progressed over left arm to cover entire arm with irregular patches of blue gray color and 1st generalized arm edema within 4 days.  No itch, fever, mucosal lesions.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: 10cm x 6cm area on R deltoid with slight edema, erythema, warm to touch. No streaking. Neuro/vascular intact. Postive joint pain in R shoulder x 2 days (resolved today). No SOB.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness, Myalgia
Clinical narrative: The injection was given high and posterior and the nurse said it felt like the needle hit something that felt like "burlap".  I had severe pain at the sight but know that is common side effect but then I had weakness and pain of the arm that went past the 4 days so I reported it to the appropriate department.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Aspiration, Coma, Sudden infant death syndrome
Clinical narrative: Patient is a 4 month old male with a history of neonatal pneumonia (resolved) and mild GER. Seen in clinic on 11/3/5 for his four month well child check. Patient was vigorous and healthy. Received his vaccinations. Per his mother, he acted fine the rest of the day. That night, he was found unresponsive in a bassinet shortly after having been placed there by his sitter, with the ensueing interval of approximately 5 minutes. CPR was performed by the sitter and paramedics, but the patient was declared dead shortly thereafter. Autopsy declared the cause of death to be SIDS after finding no significant disease process, trauma or congenital anomaly. Autopsy also revealed aspiration & obstruction of both main bronchi & alveoli by aspirated material due to gastric outlet restriction. No new terms found in medical records from PCP.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: PATIENT DEVELOPED A RED, SWOLLEN, ITCHY UPPER ARM AT THE ADMINISTRATION SITE WITHIN 12 HOURS OF ADMINISTRATION. PATIENT TREATED WITH STAT ORAL DIPHENYDRAMINE PRESCRIBED BY PHYSICIAN. ALSO PRESCRIBED FOR THE ADVERSE REACTION WAS ATARAX 25MG PO Q 6 HRS PRN X 3 DAYS.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT DEVELOPED WARM, SWOLLEN, TENDER, REDDENED AREA AT INJECTION SITE.
Age: 0.01
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site mass, Pain, Pruritus, Rash erythematous
Clinical narrative: Seen for PE and vaccines on 01/19/06.  Phone call 01/20/06 25 cent size lump L thigh, painful, afebrile.  Seen by MD 01/21/06, 8 cm X 11 cm raised warm rough fine rash L midthigh, afebrile.  Line drawn around area, advised OTC Benedryl.  Phone call 01/22/06 area now extends 1" beyond line drawn around area, tender, pruritic, afebrile.  Advised to W&W.
Age: 0.01
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Tenderness
Clinical narrative: Seen for PE and vaccines on 01/19/06.  Phone call 01/20/06 25 cent size lump L thigh, painful, afebrile.  Seen by MD 01/21/06, 8 cm X 11 cm raised warm rough fine rash L midthigh, afebrile.  Line drawn around area, advised OTC Benedryl.  Phone call 01/22/06 area now extends 1" beyond line drawn around area, tender, pruritic, afebrile.  Advised to W&W.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Convulsion, Electroencephalogram abnormal, Muscle twitching
Clinical narrative: 01/04/2006 well child check received MMR vaccine, 01/05/2006 had seizure at day care seen in ED abnormal EEG admitted to hospital 01/06/2006. 01/07/2006 d/c'd on Depakote. Information received from ER summary states twitch as additional finding. msv
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Abortion, Arthralgia, Fatigue
Clinical narrative: Spontaneous abortion 3 months after AVA 1.  Fatigue and general aching of joints and muscles 7 months after AVA 1.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Drug ineffective
Clinical narrative: Vaccine failure, flu shot on 11/08/2005.  patient tested flu A positive on 01/23/2006.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash erythematous
Clinical narrative: Mom states baby started with red bumps on legs on 01/18/2006 which progressed to whole body by 01/19/2006.
Age: 44.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Oedema peripheral
Clinical narrative: Had TDAP 01/20/2006, right deltoid, no symptoms until 48 hours after vaccine, arm became red, hot, and swollen, edema 1.5 inched wide and 1 inch long.  No systemic reaction, just local redness, wound site no visable, no drainage.  Cloth cover, ice pack to for pain and edema. Advised to call doctor for follow up.