chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Gingival abscess, Nausea, Pyrexia, Vertigo
Clinical narrative: Information has been received from a 67 year old female registered Nurse with chronic mucitis and an allergy to ampicillin and a history of sinus infection, calcium in breast and cholecystectomy (removed in past) who on 10/6/06 was vaccinated SC with a dose of Varicella Zoster vaccine. Concomitant therapy included Claritin, Lisinopril, Vitamins unspecified, calcium unspec vitamin D unspec, Synthroid, baby aspirin and Cortisone gel. On 10/10/06 at 16:00, the pt developed nausea, vertigo and loss of balance. She felt better lying down and closing her eyes. She felt like the room was spinning. No vomiting or diarrhea was noted. She had not taken her temp, but if she has a fever it is low grade. The pt currently has an abscess in her mouth currently which she has an appointment to be seen on 10/11/06. She reported that her blood pressure had been stable and she dose not have diabetes. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006.  Information has been received from a 67 year old female Registered Nurse with "chronic mucitis", anxiety disorder and an allergy to ampicillin and a history of sinus infections, calcium in breasts and cholecystectomy (removed in past) who on 06-OCT-2006 was vaccinated SC with a first dose of VARIVAX (Merck) (lot # 652965/0622F).  Concomitant therapy included CLARITIN, lisinopril (manufacturer unknown), vitamins (unspecified), calcium (unspecified) (+) vitamin D (unspecified), SYNTHROID, baby aspirin and "cortizone gel".  On 10-OCT-2006 at 16:00, the patient developed nausea, vertigo and loss of balance.  She felt better lying down and closing her eyes.  She felt like the room was spinning.  No vomiting or diarrhea was noted.  She had not taken her temperature, but if she had a fever "it is low grade".  The patient currently has an abcess in her mouth currently which she has an appointment to be seen on 11-OCT-2006.  She reported that her blood pressure had been stable and she does not have diabetes.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information from the physician indicated that the patient was vaccinated at a pharmacy.  No significant problems were noted in the patient's chart.  The patient's symptoms were reported resolved on 30-OCT-2006.  The physician reported that it was unclear whether related to the vaccine.  Laboratory tests included an office visit on 30-OCT-2006 for a "blood issue".  No further information is expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac disorder, Electrocardiogram abnormal, Palpitations
Clinical narrative: Information has been received from a physician concerning a 64 year old female with rheumatoid arthritis and allergic reaction to Erythromycin (nausea) who on 10/04/06 was vaccinated with a dose of varicella zoster vaccine (lot 652936/0981F). The physician reported that the pt received a 0.5ml dose. Concomitant therapy included Atenolol, Carisoprodol (Soma), Estrace, Cytotec, Lodine, Pamelor. Subsequently on 10/04/06, the pt experienced increased heart palpitations. The pt was seen for follow up on 10/9/06, the palpitations were persisting and the pt had frequent PVC on EKG. Prescription drug treatment was required, the pts Atenolol was increased. At the time of the report, the pt had not recovered. No quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Information has been received from a physician concerning a female who on 10/09/06 was vaccinated with a 0.65 ml dose of Varicella Zoster vaccine. On 10/12/06 the pt experienced red rashes on both arms similar to poison ivy or oak. It was reported that the pt has not been near either plant. No other vaccinations were administered. Unspecified medication attention was sought. At the time of the report, the pt had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis, Flushing
Clinical narrative: Information has been received from a physician concerning an 84 year old white female who on 13-OCT-2006 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included nifedipine, losartan potassium (MSD), albuterol and ipratropium bromide (ATROVENT). On 13-OCT-2006 within minutes to hours of the injection the patient experienced flushing and transient dermatitis on the face, arms and legs. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. 6/17/10 Additional information has been received by the physician indicating that the "reaction turned out to be from taking NIACIN, which the patient bought by accident instead of THIAMINE". No further information was reported.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Urticaria
Clinical narrative: Information has been received from a physician concerning a 72 year old female with allergies to penicillin, sulfa, tetracycline, and prochlorperazine maleate (COMPAZINE) and no other medical history who on 16-OCT-2006 was vaccinated SC in the right arm with a dose of ZOSTAVAX (lot #652936/0981F). Concomitant therapy included raloxifene hydrochloride (EVISTA). On 17-OCT-2006 the patient developed a welt at the site of injection. The site of injection was swollen, red, and itchy. The physician stated that the patient had an appointment to be examined on 18-OCT-2006. The patient was currently taking topical hydrocortisone cream and would be advised to take diphenhydramine. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: This is in follow-up to report(s) previously submitted on 11/14/2006. Information has been received from a healthcare worker concerning a 72 year old female breast cancer survivor with high blood pressure, high cholesterol, sulfonamide allergy and streptomycin and NORFLEX allergies and a history of kidney stone and on 30-AUG-2006 at 14:00 PM was vaccinated SC in the right arm with a 0.65 mL first dose of ZOSTAVAX (Merck) (lot # 652965/0622F). Concomitant therapy included celecoxib (CELEBREX), lisinopril (ZESTRIL), hydrochlorothiazide (manufacturer unknown), lovastatin, verapamil, tamoxifen citrate, and loratadine (CLARITIN). There was no illness at the time of vaccination. On 30-AUG-2006, the patient developed a "very large spot that was red, raised and itchy." No fever was noted. The patient took diphenhydramine hydrochloride (BENADRYL), but the spot was still present at the injection site as of 30-OCT-2006. The spot was smaller, but still present. The patient did not seek medical attention and no diagnostic laboratory tests were performed. The patient has no known adverse events following prior vaccination. There was no product quality complaint involved. Additional information has been requested. Additional information has been received from the healthcare worker who reported that the immediately after the patient's immunization, in the early evening of 30-AUG-2006, the site was softball-sized and interfered with her sleep. One month later, her injection site was still itchy, red, and raised. The patient recovered in October 2006. No further information is expected.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Body temperature, Herpes zoster, Injection site rash, Pain, Rash pruritic
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 61 year old patient with allergies to codeine and nalbuphine hydrochloride (NUBAIN) and not other medical history who on 18-OCT-2006 was vaccinated SC with a 0.65 mL dose of ZOSTAVAX. Concomitant vaccination on the same day included a dose of PNEUMOVAX 23. On 19-OCT-2006, the patient presented with a zoster rash. The nurse reported that the patient had an injection site reaction that looked like shingles which was painful and itchy. The rash looked like hives, but was not blistery. The rash spread from the injection site in the left arm to her chest. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006.  Information has been received from a physician and a licensed practical nurse concerning a 61 year old female patient with allergies to codeine and NUBAIN and no other medical history who on 18-OCT-2006 was vaccinated SC in the left arm with ZOSTAVAX (Merck) (lot # 652925/0621F).  Concomitant vaccination on the same day included a dose of PNEUMOVAX.  On 19-OCT-2006, the patient presented with a zoster rash.  The nurse reported that the patient had an injection site reaction that looked like shingles which was painful and itchy.  The rash looked lik hives, but was not blistery.  The rash spread from the injection site in the left arm to her chest.  Unspecified medical attention was sought.  No diagnostic laboratory tests were performed.  At the time of the report, the patient had not recovered.  A product quality complaint was not involved.  Additional information indicated that on 20-OCT-2006 the patient developed possible herpes zoster which was described as mutiple, red, indurated patches over the left deltoid 1-3 cm in size.  Her maximum temperature was 99.6 pain was rated as 5 (on a scale of 0-10) and other systemic symptoms included malaise and myalgias.  Subsequently the patient recovered.  It was reported that the patient had a history childhood chickenpox.  No recent  exposure to chickenpox or herpes zoster was reported.  No further information is available.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 61 year old patient with allergies to codeine and nalbuphine hydrochloride (NUBAIN) and not other medical history who on 18-OCT-2006 was vaccinated SC with a 0.65 mL dose of ZOSTAVAX. Concomitant vaccination on the same day included a dose of PNEUMOVAX 23. On 19-OCT-2006, the patient presented with a zoster rash. The nurse reported that the patient had an injection site reaction that looked like shingles which was painful and itchy. The rash looked like hives, but was not blistery. The rash spread from the injection site in the left arm to her chest. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006.  Information has been received from a physician and a licensed practical nurse concerning a 61 year old female patient with allergies to codeine and NUBAIN and no other medical history who on 18-OCT-2006 was vaccinated SC in the left arm with ZOSTAVAX (Merck) (lot # 652925/0621F).  Concomitant vaccination on the same day included a dose of PNEUMOVAX.  On 19-OCT-2006, the patient presented with a zoster rash.  The nurse reported that the patient had an injection site reaction that looked like shingles which was painful and itchy.  The rash looked lik hives, but was not blistery.  The rash spread from the injection site in the left arm to her chest.  Unspecified medical attention was sought.  No diagnostic laboratory tests were performed.  At the time of the report, the patient had not recovered.  A product quality complaint was not involved.  Additional information indicated that on 20-OCT-2006 the patient developed possible herpes zoster which was described as mutiple, red, indurated patches over the left deltoid 1-3 cm in size.  Her maximum temperature was 99.6 pain was rated as 5 (on a scale of 0-10) and other systemic symptoms included malaise and myalgias.  Subsequently the patient recovered.  It was reported that the patient had a history childhood chickenpox.  No recent  exposure to chickenpox or herpes zoster was reported.  No further information is available.
Age: 89.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Feeling hot, Glossodynia
Clinical narrative: Information has been received from a physician concerning an 89 year old female with high cholesterol, high blood pressure and osteopenia who on 09-OCT-2006 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX. Concomitant vaccination included a dose of influenza virus vaccine (unspecified) on 05-OCT-2006. In the morning of 10-OCT-2006 the patient experienced excruciating body pain, burning and throbbing of ears, pressure in head, stomach pain, severe headache and was lightheaded. She had achiness and tightness with sore muscles of the neck, shoulders and arms. Her entire body was weak, she was unable to turn her head. She also had burning in mouth and tongue. Unspecified medical attention was sought. The patient had improvement, but was not fully recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Headache, Hypokinesia, Myalgia, Neck pain, Pain
Clinical narrative: Information has been received from a physician concerning an 89 year old female with high cholesterol, high blood pressure and osteopenia who on 09-OCT-2006 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX. Concomitant vaccination included a dose of influenza virus vaccine (unspecified) on 05-OCT-2006. In the morning of 10-OCT-2006 the patient experienced excruciating body pain, burning and throbbing of ears, pressure in head, stomach pain, severe headache and was lightheaded. She had achiness and tightness with sore muscles of the neck, shoulders and arms. Her entire body was weak, she was unable to turn her head. She also had burning in mouth and tongue. Unspecified medical attention was sought. The patient had improvement, but was not fully recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Paraesthesia oral, Sensation of pressure
Clinical narrative: Information has been received from a physician concerning an 89 year old female with high cholesterol, high blood pressure and osteopenia who on 09-OCT-2006 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX. Concomitant vaccination included a dose of influenza virus vaccine (unspecified) on 05-OCT-2006. In the morning of 10-OCT-2006 the patient experienced excruciating body pain, burning and throbbing of ears, pressure in head, stomach pain, severe headache and was lightheaded. She had achiness and tightness with sore muscles of the neck, shoulders and arms. Her entire body was weak, she was unable to turn her head. She also had burning in mouth and tongue. Unspecified medical attention was sought. The patient had improvement, but was not fully recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 73 year old female consumer with a sulfonamide allergy and a history of shingles who on 05-OCT-2006 was vaccinated with a dose of ZOSTAVAX. There was no concomitant medication. Subsequently "a few days" after getting the vaccine she developed a "really bad rash." As of 24-OCT-2006 the patient had not recovered. Medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HBHEPB, VARZOS
Symptoms: Medication error
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with one dose of ZOSTAVAX. The physician reported that the vaccine was administered using COMVAX as a diluent. The reporter had not heard of any reaction to this. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Information has been received from a physician concerning a pt who on an unspecified date was vaccainted with a dose of Varicella vaccine. Subsequently the pt developed shingles after getting the vaccine. No further information has been available. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Aphonia, Pruritus, Rash, Reaction to previous exposure to any vaccine, Varicella post vaccine
Clinical narrative: Information has been received from a 66 year old female with asthma, restless legs syndrome, and an allergy to an unspecified antibiotic who on 26-OCT-2006 was vaccinated SC with a 0.5 mL dose of ZOSTAVAX. Concomitant vaccination at the same time included a dose of influenza virus vaccine (unspecified). Other concomitant medication included montelukast sodium (MSD), clonazepam (CLONOPIN), and ropinirole hydrochloride (REQUIP). on 26-OCT-2006, nine hours after vaccination, the patient began to itch all over. She was treated with cetirizine hydrochloride (ZYRTEC), but continued to itch all over. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. 6/17/10 Additional informationi has been received from the patient's physician who reported that on 27-OCT-2006, the patient had puritis and a rash and went to the emergency room. The patient recovered on 29-OCT-2006. Medical records revealed that the patient was admitted to the emergency room on 27-OCT-2006 at 19:38 PM. The complaint was reaction to shingles vaccine, rash, itch and voic going. It was noted that the patient had a history of high cholesterol and hypothyroidism. The patient took 40 mg of prednisone and at 20:00 PM no rash was noted. She was alert and oriented, her speech was clear, and no shortness of breath was noted. The clinical impression was that she had an acute allergic reaction to varicella-zoster virus vaccine live ZOSTAVAX (Merck). The patient departed the emergency room at 21:40 PM. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Eye disorder, Transient ischaemic attack
Clinical narrative: Information has been received from a physician concerning a 62 year old male who on 9/14/06 was vaccinated with a dose of Varicella Zoster vaccine. On 9/14/06, following vaccination, the pt experienced right eye transient ischemic attack (mini stroke). A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006.  Information has been received from a physician concerning a 62 year old male who on 14-SEP-2006 was vaccinated with a dose of ZOSTAVAX (Merck).  ON 14-SEP-2006, following vaccination, the patient experienced right eye transient ischemic attack (TIA).  A product quality complaint was not involved.  Additional information has been received from the physician who reported that the patient was at risk of TIA, however, he had not previously experienced one.  The physician reported that he would have more diagnostic information in the future, including an MRI, echocardiogram, carotid ultrasound, and cardiovascular workup which may allow better understanding of the stroke pathway.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2006; 12/20/2006. Information has been received from a physician concerning a 62 year old male who on 14-SEP-2006 was vaccinated with a dose of ZOSTAVAX (Merck). On 14-SEP-2006 following vaccination, the patient experienced right eye transient ischemic attack. A product quality complaint was not involved. Additional information has been received from the physician who reported that the patient was at risk for TIA, however, he had not previously experienced one. The physician reported that he would have more diagnostic information in the future, including an MRI, echocardiogram, carotid ultrasound, and cardiovascular workup which may allow better understanding of the stroke pathway. Additonal information has been received from the physician's office. It was reported that the patient had just recently had his MRI approved by his insurance company. The physician will provide the results when the MRI occurs. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blister, Lip ulceration
Clinical narrative: Information has been received from a physician concerning a 62 year old female with a codeine allergy and a history of breast cancer 8 years ago, who on 10/12/06 was vaccinated SC in the arm with a 0.65ml dose of Varicella Zoster vaccine (lot 652966/0722F). Concomitant therapy included Vagifem. Concomitant vaccination included a dose of Influenza vaccine (unspec) given in the other arm on the same day. On 10/28/2006 the pt experienced fever blisters or cold sores on her lips. The pt was seen by a physician on 10/30/06, no lab or diagnostic test were performed. At the time of this report the pt had not recovered. no product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARZOS
Symptoms: Infection transmission via personal contact, Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning her 4 year old grandson who developed a fever and a rash after the reporter was vaccinated on 11/26/06 with a 0.65ml dose of varicella zoster vaccine. The reporter, who has no allergies, a history of pancreas cancer, and was on no concomitant medication, indicated that on the date of her vaccination, she saw her grandson later in the afternoon as well as several days after. On 10/28/06 her grandson woke up with a fever and as of 10/31/06 he developed a rash on his face and front and back above the waist. A product complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Retching
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a 2ml oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). Subsequently the patient vomited. It noted that the dose was not repeated. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a health professional indicated that the patient gagged a little but swallowed the dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live.  There was no vomiting.  Additional information is not expected.
Age: 0.21
Sex: F
Vaccine: RV5
Symptoms: Vomiting projectile
Clinical narrative: Information ahs been received from a health professional concerning a 10 week old female, with no medical history and no allergies, who on 09/11/06, spit up while being vaccinated with a firs oral dose of Rotavirus vaccine (lot 653661/0146F) (also reported as lot 654664/0726F), and did not received a full dose. Other vaccines administered on 8/25/06 included a first IM dose in the right thigh of Pediarix (lot AC21B065AA), a first IM dose in the left thigh of ActHib (lot 4E902AA) and a first dose IM dose in the left thigh of Prevnar (lot B086498). There was no illness at the time of vaccination and no adverse events following prior vaccination. No product quality complaint was involved. Follow up information from a health professional indicated that on 9/11/06, about 15 seconds after receiving Rotavirus vaccine the pt projectile vomited. It was noted that the pt did not appear fussy following the dose. Additional information is not expected.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from health professional concerning a 16 week old female who was vaccainted with a first oral 2ml dose of Rotavirus vaccine. No problems were note with the administration. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a registered nurse concerning less than 5 infants who were vaccainted with a first dose of Rotavirus vaccine. It was reported that the infants were vaccainted after the age of 12 weeks. medical attention was sought. There was no product quality complaint involved.
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Agitation, Crying, Insomnia, Irritability
Clinical narrative: Information has been received form a nurse practitioner concerning a male who in 2006 was vaccinated with the first dose of Rotavirus vaccine. The NP reported that the pt subsequently became fussy for 2-3 days. On 9/29/06, the pt was vaccinated PO with the second dose of Rotavirus vaccine. On 9/29/06, the pt again became fussy (more severe that after the first dose), was crying, had severe abdominal pain and was not sleeping. Unspecified medical attention was sought and the pt was subsequently sent to the hospital (pt not admitted) for an abdominal ultrasound to rule out intussusception. The pt was found not to have intussusception. After 5-6 days the pts events resolved. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received form a nurse practitioner concerning a male who in 2006 was vaccinated with the first dose of Rotavirus vaccine. The NP reported that the pt subsequently became fussy for 2-3 days. On 9/29/06, the pt was vaccinated PO with the second dose of Rotavirus vaccine. On 9/29/06, the pt again became fussy (more severe that after the first dose), was crying, had severe abdominal pain and was not sleeping. Unspecified medical attention was sought and the pt was subsequently sent to the hospital (pt not admitted) for an abdominal ultrasound to rule out intussusception. The pt was found not to have intussusception. After 5-6 days the pts events resolved. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Infection transmission via personal contact, Muscle spasms, Nausea, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 27 year old mother, with no medical history and no allergies who's infant, was vaccainted with a dose of Rotavirus vaccine (lot number 652964/0145F) on 7/28/06. There was no concomitant medications. Within 24 hours of 7/28/06 the pt was severely ill with diarrhea, cramping, and nausea for 3 or 4 days that was noted to be possibly from shedding. It was noted that the pt nursed her infant every 2 to 3 hours. It was reported that the pt recovered. No lab or diagnostic tests were performed. Unspecified medical attention was sought. no product quality complaint was involved. Follow up information from a health professional indicated that the vaccainted child was perfectly fine and had no symptoms of diarrhea. The reporter thought that it would be strange for the mother to have developed diarrhea in such a short period of time of 24 hours after the infant receiving the vaccine and that most adults would be immune to Rotavirus vaccine. The reporter noted that no family member were immunocompromised. The reporter also noted that the diarrhea could have been due to a viral illness that the family had acquired just coincidentally at the time that the child was vaccinated with Rotavirus vaccine.  Follow-up information from a health professional indicated that the patient was breast feeding the same day as the baby was vaccinated with a dose of ROTATEQ and developed severe diarrhea.  It was reported that there were no culture work done since she did not seek medical attention or notify until the baby's next immunization.  Additional information is not expected.
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Infection transmission via personal contact
Clinical narrative: Information has been received from a health professional concerning a father whose infant was vaccinated with a dose of ROTATEQ (lot # 652964/0145F) on 28-JUL-2006. There was no concomitant medication. It was reported that the patient was severely ill with diarrhea, possibly from shedding. Follow-up information from a health professional indicated that the vaccinated child was perfectly fine and had no symptoms of diarrhea. The reporter thought that it would be strange for the patient to have developed diarrhea in such a short period of time of 24 hours after the infant receiving the vaccine and that most adults would be immune to ROTATEQ. The reporter noted that no family members were immunocompromised. The reporter also noted that the diarrhea could have been due to a viral illness that the family had acquired just coincidentally at the same time that the child was vaccinated with ROTATEQ. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Infection transmission via personal contact, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 24 month old, who's infant sibling was vaccinated with a dose of Rotavirus vaccine (lot 652964/0145F) on 7/28/06. There was no concomitant medication. It was reported that the pt developed diarrhea. Follow up information from a health professional indicated that the vaccainted child was perfectly fine and had no symptoms of diarrhea. The reporter thought that it would be strange for the pt to have developed diarrhea in such a short period of time of 24  hours after the infant receiving the vaccine and that most adults would be immune to Rotavirus vaccine. the reporter noted that no family member were immunocompromised. The reporter also noted that the diarrhea could have been due to a viral illness that the family had acquired just coincidentally at the time that the child was vaccinated with Rotavirus vaccine. the pts brother experienced diarrhea following vaccination of his infant sibling with Rotavirus vaccine (WAES0610USA05119). Additional information has been requested. Follow-up information from a health professional indicated that the vaccinated child was perfectly fine and had no symptoms of diarrhea.  The reporter thought that it would be strange for the patient to have developed diarrhea in such a period of time of 24 hours after the infant receiving the vaccine and that most adults would be immune to ROTATEQ.  The reporter noted that no family member were immunocompromised.  The reporter also noted that the diarrhea could have been due to a viral illness that the family had acquired just coincidentally at the same time that the child was vaccinated with ROTATEQ.  The patient's brother experienced diarrhea following vaccination of his infant sibling with ROTATEQ (WAES# 0610USA05119).  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Infection transmission via personal contact
Clinical narrative: Information has been received from a health professional concerning a 5 year old, who's infant sibling was vaccinated with a dose of ROTATEQ vaccine (lot 652964/0145F) on 7/28/06. There was no concomitant medication. It was reported that the pt developed diarrhea. Follow up information from a health professional indicated that the vaccainted child was perfectly fine and had no symptoms of diarrhea. The reporter thought that it would be strange for the pt to have developed diarrhea in such a short period of time of 24  hours after the infant receiving the vaccine and that most adults would be immune to ROTATEQ vaccine. the reporter noted that no family member were immunocompromised. The reporter also noted that the diarrhea could have been due to a viral illness that the family had acquired just coincidentally at the time that the child was vaccinated with ROTATEQ vaccine. the pts brother experienced diarrhea following vaccination of his infant sibling with ROTATEQ vaccine (WAES0610USA05118). Additional information has been requested.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Regurgitation
Clinical narrative: Information has been received from a physician concerning an 18 week old patient who, "two weeks ago," on approximately 25-SEP-2006, was vaccinated with a first 2 ml oral dose of ROTATEQ. It was reported that the patient regurgitated the dose. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested. 04/04/2010 Follow-up  information from the physician indicated that the patient did not experience any symptoms. The patient regurgiated a partial dose. Additional follow-up information from the physician indicated that the infant spit out some of the first dose but had no problem with it. Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Constipation
Clinical narrative: Information has been received from a health professional concerning her 10 week old son who was vaccinated with a first dose of Rotavirus vaccine. Subsequently the pt experienced constipation. No product quality complaint was involved. Additional information is not expected.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a physician concerning a 13 week old male who, two weeks ago, on approx 9/25/06 was vaccinated with a first 2ml oral dose of Rotavirus vaccine. no adverse event was involved. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.24
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 3 month old female with no medical history who on 10/5/06 was vaccainted PO with the first dose of Rotavirus vaccine. There was no concomitant therapy. The physician reported that on 10/6/06, the pt experienced severe diarrhea (about 20 episodes) and vomiting. The pt was subsequently seen by the physician. No lab/diag test were performed. On 10/9/06, the pts severe diarrhea and vomiting fully resolved. The physician considered the diarrhea and vomiting to be other important medical events as the pt was seen a few days after vaccination (OMIC). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a pt who was vaccainted with  a dose of Rotavirus vaccine. it was reported that the pt was experiencing diarrhea for 14 days post vaccination. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: DTAP, PNC, RV5
Symptoms: Diarrhoea, Vomiting projectile
Clinical narrative: Information has been received from a physician concerning a 9-week-old patient who on 06-SEP-2006 was vaccinated PO with the first 2.0 mL dose of ROTATEQ. Concomitant vaccinations administered on that same day included a dose of PREVNAR and a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The physician reported that on 06-SEP-2006 the patient developed projectile vomiting. The physician indicated that the patient also had projectile vomiting on 10-SEP-2006, 12-SEP-2006, 29-SEP-2006 and 02-OCT-2006. The physician noted that each of the projectile vomiting incidents occurred when the patient was being breast-fed. The physician also reported that on 09-OCT-2006 the patient developed watery stool and diarrhea. Unspecified medical attention was sought. By 11-OCT-2006 the patient had fully recovered from their events. Additional information has been requested.
Age: 0.14
Sex: M
Vaccine: RV5
Symptoms: Incorrect dose administered
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 15 week old male who on 04 Oct 2006 was vaccinated PO with the first 2.0mL dose of rotavirus G1 G2 Ge G4 P1 reassortant vaccine live (human-bovine). Unspecified medical attention was sought. No adverse reaction was noted. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered
Clinical narrative: Information has been received from an office manager in a physicians office concerning a patient who was vaccinated with the first dose of ROTATEQ vaccine at 6 months of age. It was unknown if medical attention was sought. No further information is available.
Age: 0.17
Sex: F
Vaccine: HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse concerning a 2 month old female with no medical history on 10 Oct 2006 was vaccinated PO with the first 2.0mL dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). Concomitant vaccinations administered on that same day included a dose of poliovirus vaccine inactivated (unspecified), a dose of Hib conj vaccine (OMPC) {manufacturer unknown} and a dose of Prevnar. The nurse reported that on 11 Oct 2006, at approximately 0500, the patient vomited. Unspecified medical attention was sought. The nurse noted that this was a single episode of vomiting and the patient did not experience any other adverse effects. On that same day, the patient was considered to be recovered. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: DTAP, HEP, HIBV, IPV, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning an otherwise healthy 2 month old patient product of a full term deliver who on approximately 27 Sep 2006 was vaccinated with the first dose of Rotateq (human bovine). Concomitant vaccinations administered on that same day included a dose of Dtap, a dose of poliovirus vaccine inactivated (unspecified), a dose of PedVax Hib and a dose of Recombivax HB. There was no other concomitant therapy. The physician reported that on approximately 27 Sep 2006, 'right after vaccine, the patient developed watery, voluminous, non bloody stool characterized by 12-14 stools per day and fever. The patients fever initially resolved, but had since restarted. The physician also reported that the patient had occasional vomiting after feeding described as "spitting up". The patient had no upper respiratory symptoms and no rash. It was noted that the patient had no ill contacts or contacts with iguanas, turtles, and no recent travel. There was no family history of immunocompromise. It was unknown if the patient attended daycare. The patient was feeding on Isomil and had good urine output. Unspecified medical attention was sought. A stool sample was sent for culture and was negative for salmonella, shigella, campylobacter and E. coli. At the time of this report, the patient's fever persisted and the diarrhea had lasted for greater than 14 days. The outcome of the patient's vomiting was unknown. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old female who on 12 Oct 2006 was vaccinated PO with the first dose of Rotateq (human bovine). The physician reported that on 12 Oct 2006, immediately after being vaccinated, the patient vomited. The physician felt that the entire dose was lost. Unspecified medical attention was sought. On that same day, the patient was considered to be recovered as she did not exhibit any further symptoms. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning an approximately 8 week old patient who was vaccinated PO with the first 2.0 mL dose of Rotateq. The physician reported that the patient subsequently developed diarrhea. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.21
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain, Abnormal faeces, Faeces pale, Malabsorption
Clinical narrative: Information has been received from a physician concerning an approximately 10 week old healthy female with no medical history or allergies who on 05 Sep 2006 was vaccinated with the first dose of Rotateq. The physician reported that in September 2006 the patient developed abdominal pains. The patient subsequently presented with evidence of malabsorption and mucous in stool. Stool tests performed showed no blood and no white blood cells (WBCs) in the stool. Protein fecal substance was high at 1,000 and pH was 7.0, The patient  was on amino acids (Nutramigen) and was gaining weight appropriately. At the time of this report, the patient's events persisted. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician's assistant (PA) concerning a 4 month old patient with no medical history or allergies who on approximately 12 Aug 2006 was vaccinated PO with a 2.0 mL dose of Rotateq. There was no concomitant therapy. The PA reported that on approximately 12 Aug 2006, the patient developed diarrhea which resulted in 6-7 diaper changes daily. Unspecified medical attention was sought and the patient was changed to soy formula on the suspicion of a lactose intolerance. No laboratory/diagnostic test were performed. On approximately 23 Sep 2006, six weeks after onset, the patient's diarrhea resolved. The PA considered the patient's event to be non-serious. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered
Clinical narrative: Information has been received from a physician concerning a 32 month old patients who in October 2006, were vaccinated with a dose of Rotateq. Unspecified medical attention was sought. At the time of this report, no adverse reactions had been noted. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a health professional concerning a 2 month old female, with no medical history, who on 11-OCT-2006 was vaccinated with a first 2 ml oral dose of ROTATEQ. It was reported that the patient vomited immediately after the first dose, and about 1/2 the dose made it in. Vaccines, given post vomiting, included "two month old series." It was noted that the patient recovered immediately after. It was reported that a second and third dose would be given on future dates. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 5 week old patient who was vaccinated with a dose of Rotateq. No symptoms noted. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2006.  Information has been received from a registered nurse (RN) concerning a 36-day-old female who on 02-OCT-2006 was vaccinated PO with the first dose of ROTATEQ (Lot #654392/0578F).  Concomitant vaccinations administered on that same day included the first IM dose of PEDIARIX (Lot #AC21B0590A) and the first IM dose of PREVNAR (Lot #B08642H).  Unspecified medical attention was sought and no symptoms were noted.  Additional information has been requested.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered
Clinical narrative: Information has been received from a health professional concerning a 16 week old patient who on 16 Aug 2006 was vaccinated with a first oral dose of Rotateq (human bovine). It was reported that no adverse experience was related to this event. No other information was provided. Additional information has been requested.
Age: 0.48
Sex: M
Vaccine: RV5
Symptoms: Decreased appetite, Diarrhoea, Muscle spasms, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 25 week old male, with no medical history and no allergies, who was vaccinated with a first and second dose of Rotateq (human bovine) on 13 Jun 2006 and 29 Jul 2006, respectively. It was reported that there were no symptoms following the first and second dose. On 06 Oct 2006 the patient was vaccinated with a third oral dose of Rotateq (Lot # 652964/0145F). There was no concomitant medication. On 11 Oct 2006 the patient experienced foul smelling diarrhea, eight times a day. The patient did not show any signs of dehydration, no fever and has gained about 7 ounces. The patient seemed to be drinking, not eating as much. The physician also indicated that the patient has "cramping around the stool." At the time of the report the patient had been experiencing diarrhea for the past 5 days and had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Abdominal pain upper
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with an oral first dose of Rotateq (human bovine). It was reported that the patient "was having a stomach ache and that the patient's parent refused additional dosage to be given." Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information had been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a health professional concerning a 2 month old patient who was vaccinated with a 2ml oral dose of Rotateq (human bovine). Subsequently the patient vomited the complete dose. There was no time frame on when the event actually happened. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old patient who was vaccinated PO with the first dose of Rotateq (human bovine). The physican reported that, within a week, the patient experienced vomiting. Unspecified medical attention was sought. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 2 month old patient with no medical history or allergies who on 16 Oct 2006 was vaccinated PO with the first dose of Rotateq (human bovine). There was no concomitant therapy. The LPN reported that on 16 Oct 2006, the patient vomited in the office after Rotateq was administered. The LPN indicated that the vaccine was vomited as well as the contents of the patient's stomach. It was unknown if medical attention was sought. No laboratory/diagnostic tests were performed. On that same day, the patient recovered. The LPN noted that there have been no residual effects since the vomiting.  Additional information has been requested.