chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.76
Sex: M
Vaccine: DTAPH, IPV, MMR, PNC, VARCEL
Symptoms: Dermatitis bullous, Erythema, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 21 month old (also reported as a 23 month old) male child with a heart murmur and asthma and a history of influenza A who on 6/20/2005 was vaccinated subcutaneously with the first 0.5 ml dose of varicella virus vaccine live (lot 649644/1050P). Concomitant vaccinations given on that same day included the fourth dose of diphtheria toxoid + Hib conj vaccine tet toxoid _ pertussis acellular 2 component vaccine + poliovirus vaccine inactivated + tetanus toxoid given intramuscularly Pentavac (lot UE405AB), the first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 648661/0616P) given subcutaneously, the third dose of poliovirus vaccine inactivated IPOL (Lot 40298-2 given subcutaneously, and  the third dose of Pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot A67181E). There was no illness at the time of vaccination. Ten days after being vaccination, on 6/30/2005 (also reported as 7/1/2005) the patient broke out with a varicella rash characterized by scattered pink papules on his trunk, groin, limbs and cheek. Unspecified medical attention was sought. The reporter noted that the patient did not have a fever and he was prescribed cetirizine hydrochloride Zyrtec syrup. At the time of this report, the patient was recovered. additional information is not expected.
Age: 1.36
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema multiforme, Pyrexia, Rash pustular, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning an 18 month old black female with a history of premature birth (36 wks) and a strep infection on her scalp (Oct 2004) who on 11Apr05 was vaccinated SC in the right thigh with a first 0.5ml dose of varicella virus vaccine live (lot 648559/0444P). Concomitant vaccines the same day included a first dose SC in the right thigh of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot 648469/0267P) and a dose in the left thigh of diphtheria toxoid (+) pertussis acellular 5 component vaccine (+) tetanus toxoid (Daptacel). There was no illness at the time of vaccination. On 08Jun05 the pt experienced chicken pox. It was reported that it was a severe case and the child was covered with hundreds of lesions from her scalp all the way to the soles of her feet. She had a fever of 103.6F. She was started on acyclovir and the physician sent an isolate to the lab to be sure that it was chicken pox. It was noted that the pt was to be seen again on 09Jun05. No product quality complaint was involved. Follow up information from a medical assistant indicated that on 06Jun05 the pt presented to the office with scattered pustules. She was given (Atarax). On 08Jun05 she presented with a fever and fresh pustules. A viral culture was sent from the abdomen. The culture showed no virus isolated after 14 days and the final diagnosis was erythema multiform. It was noted that the pt was hospitalized for 2 days and completely recovered on 13Jun05. The physician felt the adverse experience was an other important medical event (OMIC). No additional information is expected.
Age: 1.05
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Blister, Pyrexia, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 8 year old female, with no known drug allergies, who on 10/30/1997 was vaccinated with a first subcutaneous dose in the right lower leg of varicella virus vaccine live (lot 622532/0084E and 0544F). Concomitant vaccines administered on the same day included a first subcutaneous dose in the left leg of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 620779/0480E and 0984P) and a fourth intramuscular dose in the upper right leg of Hib conj vaccine Hibtiter (Lot 7350PN). Other concomitant medications included carbinoxamine maleate Pseudoephedrine HC Palgic D 1 teaspoon, QID and nystatin cream, QID, for the treatment of diaper rash. It was reported that the patient had an upper respiratory infection and a diaper rash at the time of vaccination. There were no adverse events following prior vaccination. The physician reported that on 8/10/2005, the patient developed breakthrough varicella. Unspecified medical attention was sought, but no treatment was necessary. AT the time of this report, the patient was recovering from the breakthrough varicella. Follow up information from a health professional indicated that on 8/10/2005 the patient experienced blister lesions all over her body for 1 day and a low grade temp of 100.5. It was noted that the experience lasted approximately 7 days. The patient recovered on 8/20/2005. Additional information is not expected.
Age: 1.26
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Sepsis, Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 yr old African American non Hispanic female with a no medical history on 25Aug97 was vaccinated with a first subcutaneous dose in the right arm of varicella virus vaccine live (lot 622750/0545E). There was no illness at the time of vaccination. On 27Jan05 the pt experienced zoster C3 and was hospitalized for six days. It noted that the pt was PCR positive. Subsequently, the pt recovered. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MER, VARCEL
Symptoms: Brain neoplasm, Headache, Herpes zoster, Infection, Pyrexia
Clinical narrative: Info has been received from a physician concerning a 6 year old pt with an allergy to amoxicillin (hives), who on 9/18/2000, was vaccinated, SC in the right arm, with a 1st dose of varicella virus vaccine live. Suspect vaccination administered that day included a 2nd a 2nd dose, in the left arm of MMRII. On approximately 9/25/05, the pt developed shingles along C5 and C6. She had a low-grade fever of approximately, 100F. There was no pain or itch. Medical attention was sought but no treatment was needed. On 9/30/05, a "direct Viral exam" was performed that were positive for varicella virus. It was also reported that on approximately 8/1/05, the pt developed headaches. On 10/5/05, an MRI was performed that showed an astrocytoma. On 10/7/05, a curative resection was performed and there was no further treatment. On approximately 10/5/05, the pt recovered from shingles. It was reported that neither the pt nor her sibling (s) experienced an adverse following prior vaccination. There was no product quality complaint involved. Additional info has been requested.
Age: 1.04
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Info has been received from an RN concerning a 12 month old male with no allergies or medical history who on 9/28/05 at 10:30 AM, was vaccinated, SC, in the left thigh with a 1st 0.5 ml dose of varicella virus vaccine live (lot 647960/0070R). Concomitant vaccination at the same time included a, SC, 1st dose in the right thigh of MMRII and a 4th dose in the right upper thigh of Hib conj vaccine (OMPC) (lot 649885/0604P). There was no illness at the time of vaccination. On 9/28/05, the pt developed a red raised area at the injection site immediately after injection. No diagnostic lab tests were performed. At the time of the report, the pt was recovering. A product quality complaint was not involved. Follow-up info was received from the RN who reported that on 9/28/05, the pt had a local reaction at the site of injection only. He was given Benadryl and the reaction resolved. It was noted that the pt had no adverse events following prior vaccination. No further info is expected.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pyrexia, Urticaria
Clinical narrative: Info has been received from a physician concerning a 12 month old white female with no medical history who on 9/29/05, was vaccinated SC, in the left thigh, with the 1st dose of 0.5 ml dose of varicella virus vaccine live. Secondary suspect vaccinations on that same day, included the 1st dose in the right thigh, of MMRII. There was no illness at the time of vaccination. The physician reported that on the morning of 9/30/05, the pt developed large red and warm wheals on both her buttocks and a slight fever. The pt was treated with Benadryl, but no lab or diagnostic tests were performed. On 10/3/05, the pt was seen by the physician and her fever was noted to be resolved. On 10/15/05, the pt's large red and warm wheals on her buttocks resolved as well. Additional info has been requested.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Herpes zoster, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 13 month old female who on 11/26/2001 was vaccinated with a subcutaneous dose of varicella virus vaccine live. Concomitant vaccine administered on the same day included a subcutaneous dose of measles mumps rubella vaccine. There was no illness at the time of vaccination. At the age of 13 months, in approximately Dec 2001, the patient experienced varicella. On 6/24/2005 a skin lesion and blood was collected for VZV identification PCR> On 6/25/2005 the patient had an onset of vesicles which were diagnosed as zoster vaccine strain. The patient was seen in the office on 6/29/2005. The patient was given Acyclovir (Zovirax). It was reported that the patient recovered. Additional information is not expected.
Age: 1.18
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash pustular, Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 month old male with no medical history or allergies who on 10/3/2005 was vaccinated SC in the right leg with a 0.5ml dose of varicella virus vaccine live (lot 651044/0323R). There was no concomitant therapy. The LPN reported that on the night of 10/03/2005, the patient developed three pustules. On 10/21/2005. the patient presented to the physicians office with multiple chickenpox lesions and a fever of 99. No treatment was required and at the time of this report, the patients chickenpox persisted. Additional information is not expected.
Age: 1.31
Sex: M
Vaccine: FLU3, BCG, VARCEL
Symptoms: Rash papular
Clinical narrative: Information has been received from a physician concerning a 16 month old white male with a history of prematurity(born at 32 weeks gestation) who on the morning of 20 December 2005, at 15 3/4 months of age, was vaccinated subcutaneously in the right thigh with the first dose of varicella virus vaccine live (Oka/Merck) (lot # 649486/0419R). There was not concomitant therapy. The physician reported that on the morning of 03 January 2006, the patient presented to his office with papulovesicular lesions and umbilicated lesions over his body. On 09 January 2006, the patients papulovesicular lesions and umbilicated lesions resolved. No further information is available.
Age: 1.98
Sex: F
Vaccine: HIBV, VARCEL, HIBV, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Information has been received from a LPN concerning a 23 month old healthy female with no allergies, who on 06Jun05 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot 649440/0116R). Concomitant vaccination given on the same day included: a dose of Hib conj vaccine (Acthib). On the same day after vaccination, the pt developed a high fever and seizure. The child was seen in the ER. Subsequently, the pt recovered from high fever and seizure. No product quality complaint was involved. The reporter considered the high fever and seizure to be disabling. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Information has been received from a health professional concerning an 18 month old white male with a milk allergy and an amoxicillin allergy and a history of premature birth at 30 wks gestation who on 13Feb06 was vaccinated in the right thigh with a dose of varicella virus vaccine live (lot 652078/0940R). There was no illness at the time of vaccination. On 13Feb06, within minutes of receiving vaccine, the pt experienced 2 large hives at the vaccination site. There were no respiratory symptoms. There was no egg allergy. The pt was treated with diphenhydramine hcl (Benadryl), 3/4 tsp and will continue it at home. No labs or diagnostic tests were done. Subsequently, the pt recovered. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning an 18 month old white male with a milk allergy and an amoxicillin allergy and a history of premature birth at 30 wks gestation who on 13Feb06 was vaccinated in the right thigh with a dose of varicella virus vaccine live (lot 652078/0940R). There was no illness at the time of vaccination. On 13Feb06, within minutes of receiving vaccine, the pt experienced 2 large hives at the vaccination site. There were no respiratory symptoms. There was no egg allergy. The pt was treated with diphenhydramine hcl (Benadryl), 3/4 tsp and will continue it at home. No labs or diagnostic tests were done. Subsequently, the pt recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Injection site mass
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with no known medical history or allergies who on 15-MAR-2006 was vaccinated with 0.5 ml SC first dose of varicella virus vaccine live (lot# 652454/1017R). There was no concomitant medication. On 16-MAR-2006 the patient developed redness and lump the size of a golf ball at the injection site. There was no pain, warmth, or tenderness. She was treated with ice. On 17-MAR-2006 the area had increase to the size of a golf, the redness increased, it was warm to touch and she had a temperature of 100F. She was seen by the physician and diagnosed with infection at injection site. She was treated with cephalexin (KEFLEX) 500 mg four times a day. The patient was scheduled to be seen on 18-MAR-2006 and would be admitted to the hospital if the size increased. At the time of the report the patient had not yet recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site infection, Injection site mass, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with no known medical history or allergies who on 15-MAR-2006 was vaccinated with 0.5 ml SC first dose of varicella virus vaccine live (lot# 652454/1017R). There was no concomitant medication. On 16-MAR-2006 the patient developed redness and lump the size of a golf ball at the injection site. There was no pain, warmth, or tenderness. She was treated with ice. On 17-MAR-2006 the area had increase to the size of a golf, the redness increased, it was warm to touch and she had a temperature of 100F. She was seen by the physician and diagnosed with infection at injection site. She was treated with cephalexin (KEFLEX) 500 mg four times a day. The patient was scheduled to be seen on 18-MAR-2006 and would be admitted to the hospital if the size increased. At the time of the report the patient had not yet recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal sleep-related event, Apnoea, Bronchitis chronic, Cardio-respiratory arrest, Sleep apnoea syndrome
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 2 month old male pt who experienced apnea, cyanosis, body temp decreased and depressed level of consciousness and death. At 2 months of age, the pt received a dose of Prevnar, along with a dose of Haemophilus B conjugate vaccine (manf unk) (diphtheria crm197 protein conjugate) and the first dose of Pediarix (diphtheria/tetanus acellular pertussis/hep B vaccine/polio virus inactivated) on 18Apr06. The pt's concurrent illness includes infantile apnoeic attack (placed on apnea monitor due to apnea spells while in the hospital following his premature birth), a past history of premature baby (born 4 weeks premature). After being sent home from the hospital, the subject had several apnoeic episodes which reportedly decreased in subsequent weeks. Indication for Prevnar was immunization. Product was administered on 18Apr06. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On 18Apr06 at 11:15AM, the infant received the first dose of Pediarix, along with a dose of Prevnar and Haemophilus B conjugate vaccine. The infant tolerated the injections well and was sent home. On the same day as vaccination, the infant died. According to the mother, the monitor went off three times that night and following the third alarm, the mother reportedly found the infant to be apneic, cyanotic, cold, and unresponsive. Emergency medical services were summoned and the infant was transported to the emergency dept. Attempts at resuscitation were unsuccessful and the infant was pronounced dead. The cause of death was unspecified. An autopsy was planned; however, the results were not reported. This report was received from manf. No additional information was available at the time of this report.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 2 month old male pt who experienced apnea, cyanosis, body temp decreased and depressed level of consciousness and death. At 2 months of age, the pt received a dose of Prevnar, along with a dose of Haemophilus B conjugate vaccine (manf unk) (diphtheria crm197 protein conjugate) and the first dose of Pediarix (diphtheria/tetanus acellular pertussis/hep B vaccine/polio virus inactivated) on 18Apr06. The pt's concurrent illness includes infantile apnoeic attack (placed on apnea monitor due to apnea spells while in the hospital following his premature birth), a past history of premature baby (born 4 weeks premature). After being sent home from the hospital, the subject had several apnoeic episodes which reportedly decreased in subsequent weeks. Indication for Prevnar was immunization. Product was administered on 18Apr06. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On 18Apr06 at 11:15AM, the infant received the first dose of Pediarix, along with a dose of Prevnar and Haemophilus B conjugate vaccine. The infant tolerated the injections well and was sent home. On the same day as vaccination, the infant died. According to the mother, the monitor went off three times that night and following the third alarm, the mother reportedly found the infant to be apneic, cyanotic, cold, and unresponsive. Emergency medical services were summoned and the infant was transported to the emergency dept. Attempts at resuscitation were unsuccessful and the infant was pronounced dead. The cause of death was unspecified. An autopsy was planned; however, the results were not reported. This report was received from manf. No additional information was available at the time of this report.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 2 month old male pt who experienced apnea, cyanosis, body temp decreased and depressed level of consciousness and death. At 2 months of age, the pt received a dose of Prevnar, along with a dose of Haemophilus B conjugate vaccine (manf unk) (diphtheria crm197 protein conjugate) and the first dose of Pediarix (diphtheria/tetanus acellular pertussis/hep B vaccine/polio virus inactivated) on 18Apr06. The pt's concurrent illness includes infantile apnoeic attack (placed on apnea monitor due to apnea spells while in the hospital following his premature birth), a past history of premature baby (born 4 weeks premature). After being sent home from the hospital, the subject had several apnoeic episodes which reportedly decreased in subsequent weeks. Indication for Prevnar was immunization. Product was administered on 18Apr06. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On 18Apr06 at 11:15AM, the infant received the first dose of Pediarix, along with a dose of Prevnar and Haemophilus B conjugate vaccine. The infant tolerated the injections well and was sent home. On the same day as vaccination, the infant died. According to the mother, the monitor went off three times that night and following the third alarm, the mother reportedly found the infant to be apneic, cyanotic, cold, and unresponsive. Emergency medical services were summoned and the infant was transported to the emergency dept. Attempts at resuscitation were unsuccessful and the infant was pronounced dead. The cause of death was unspecified. An autopsy was planned; however, the results were not reported. This report was received from manf. No additional information was available at the time of this report.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Body temperature decreased, Coma, Cyanosis, Depressed level of consciousness
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 2 month old male pt who experienced apnea, cyanosis, body temp decreased and depressed level of consciousness and death. At 2 months of age, the pt received a dose of Prevnar, along with a dose of Haemophilus B conjugate vaccine (manf unk) (diphtheria crm197 protein conjugate) and the first dose of Pediarix (diphtheria/tetanus acellular pertussis/hep B vaccine/polio virus inactivated) on 18Apr06. The pt's concurrent illness includes infantile apnoeic attack (placed on apnea monitor due to apnea spells while in the hospital following his premature birth), a past history of premature baby (born 4 weeks premature). After being sent home from the hospital, the subject had several apnoeic episodes which reportedly decreased in subsequent weeks. Indication for Prevnar was immunization. Product was administered on 18Apr06. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On 18Apr06 at 11:15AM, the infant received the first dose of Pediarix, along with a dose of Prevnar and Haemophilus B conjugate vaccine. The infant tolerated the injections well and was sent home. On the same day as vaccination, the infant died. According to the mother, the monitor went off three times that night and following the third alarm, the mother reportedly found the infant to be apneic, cyanotic, cold, and unresponsive. Emergency medical services were summoned and the infant was transported to the emergency dept. Attempts at resuscitation were unsuccessful and the infant was pronounced dead. The cause of death was unspecified. An autopsy was planned; however, the results were not reported. This report was received from manf. No additional information was available at the time of this report.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC, HIBV, MMR, PNC
Symptoms: Coma, Convulsion, Cyanosis, Dyskinesia, Eye movement disorder
Clinical narrative: Mother described child had seizure, eyes rolled back, turned blue, jerked. Took child to ER immediately, nothing found per mom.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC, HIBV, MMR, PNC
Symptoms: Fatigue, Hypotonia, Oral intake reduced
Clinical narrative: Mother described child had seizure, eyes rolled back, turned blue, jerked. Took child to ER immediately, nothing found per mom.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC, HIBV, MMR, PNC
Symptoms: Convulsion, Cyanosis, Dyskinesia, Gaze palsy
Clinical narrative: Mother described child had seizure, eyes rolled back, turned blue, jerked. Took child to ER immediately, nothing found per mom.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Local reaction R  UE approx 7x8cm, erythematous warm to touch at injection site. R UE 21cm,  LUE 19cm; Tylenol prn. Instructed in monitoring.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Unevaluable event
Clinical narrative: Pt given TD in L deltoid. Pt hx: foot laceration to vl thigh and ///. ///.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: Fever, chills and dizziness.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Dtap and Prevnar given 4/24/06 right thigh IM, Hep A given left thigh IM. Pt returned to clinic 4/25/06. Mother states pt c/o pain and swelling right thigh approx 10AM 4/25/06. She applied warm compress. Came in at 2:20PM. Erythema and swelling approx 4-5cm noted and c/o pain at injection site right thigh. Dr examined pt instructed to apply ice and return if worsens.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: 5/4/06 mother presented child to health dept. Developed fine red rash on trunk, arms, legs. Approx 1-2 days ago. States babysitter did launder clothes in different detergent. 5/5/06 rash, worse, saw PCP 5/4/06 now going to ER 5/5/06.
Age: 7.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site reaction, Injection site swelling, Pruritus
Clinical narrative: Swollen R deltoid, itchy.
Age: 52.0
Sex: F
Vaccine: TTOX
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Headache
Clinical narrative: 05/08/2006: 8PM-upper left arm muscle pain, starting chilling. 05/09/06 12:15AM H/A chilling, muscle pain. 1:45AM chilling temp 101.4, H/A. Upper extremity muscle pain. Sipping fluids. Taken Ibuprofen 400mg PO. Pulse 114, BP 130/80, 0230 Temp 102, H/A, chills, muscle pain. 04:30/ diaphoric (sweating), temp 100. Still have H/A, increased muscle pain. 06:10 started chilling c/o all over body, muscle joint pain. 08:00 Temp 100.8 pulse 100, BP 110/62 chilling muscle and joint pain. H/A 10:00 AM Ibuprofen 400mg PO taken. Able to take fluids in chilling, H/A, weakness, temp 101. 6. Dr's office called at 08:10. Was told to keep taking Ibuprofen and/or Tylenol, keep up with fluids. 11:10/ chilling, H/A muscle and joint pain all over body, weakness, pulse 108, BP 108/60, Temp 102.4. 1:30PM Dr's office again. Ibuprofen 600mg PO taken with fluids, BP 100/62, Pulse 110. 3:45 Diaphoric (sweating). Dr's office returning my phone call. Continue meds and fluids. 5:50PM chilling, H/A, muscle, joint pain, 7PM Temp 100.6, Ibuprofen 600 mg PO 10:00PM Temp 102.2 still having terrible muscle, joint pain. H/A 11:50: Diaphoric (sweating) temp decreased 100.4. H/A, muscle and joint pain. Taking fluids. 05/10/06 02:45 chillings, temp 100.6. Continuing to still have terrible muscle and joint pain, weakness. 03:50 Temp 101.8. Chilling 66.1. Diaphoric (sweating) temp decreased 100.6. 09:00 starting to chill again, H/A, muscle and joint pain. 11:45 Temp 101.2. Ibuprofen 600mg PO with fluids, H/A, muscle and joint pain, weak when up. 1:35 chilling, H/A, muscle and joint pain. 3:45 diaphoric (sweating). Still have H/A, muscle and joint pain. 8:00PM taking in fluids and some food, still have H/A, muscle and joint pain through out night and next morning. 5/11/06 08:30 Up but weakness, fluids, food in, H/A, muscle and joint pain through out the day.  5/12/06: still have H/A and muscle and joint pain through out day. 5/14/06 Feeling better, occ H/A, left arm slightly sore. 5/15/06 feeling fine no H/A or pain.
Age: 52.0
Sex: F
Vaccine: TTOX
Symptoms: Heart rate increased, Hyperhidrosis, Myalgia
Clinical narrative: 05/08/2006: 8PM-upper left arm muscle pain, starting chilling. 05/09/06 12:15AM H/A chilling, muscle pain. 1:45AM chilling temp 101.4, H/A. Upper extremity muscle pain. Sipping fluids. Taken Ibuprofen 400mg PO. Pulse 114, BP 130/80, 0230 Temp 102, H/A, chills, muscle pain. 04:30/ diaphoric (sweating), temp 100. Still have H/A, increased muscle pain. 06:10 started chilling c/o all over body, muscle joint pain. 08:00 Temp 100.8 pulse 100, BP 110/62 chilling muscle and joint pain. H/A 10:00 AM Ibuprofen 400mg PO taken. Able to take fluids in chilling, H/A, weakness, temp 101. 6. Dr's office called at 08:10. Was told to keep taking Ibuprofen and/or Tylenol, keep up with fluids. 11:10/ chilling, H/A muscle and joint pain all over body, weakness, pulse 108, BP 108/60, Temp 102.4. 1:30PM Dr's office again. Ibuprofen 600mg PO taken with fluids, BP 100/62, Pulse 110. 3:45 Diaphoric (sweating). Dr's office returning my phone call. Continue meds and fluids. 5:50PM chilling, H/A, muscle, joint pain, 7PM Temp 100.6, Ibuprofen 600 mg PO 10:00PM Temp 102.2 still having terrible muscle, joint pain. H/A 11:50: Diaphoric (sweating) temp decreased 100.4. H/A, muscle and joint pain. Taking fluids. 05/10/06 02:45 chillings, temp 100.6. Continuing to still have terrible muscle and joint pain, weakness. 03:50 Temp 101.8. Chilling 66.1. Diaphoric (sweating) temp decreased 100.6. 09:00 starting to chill again, H/A, muscle and joint pain. 11:45 Temp 101.2. Ibuprofen 600mg PO with fluids, H/A, muscle and joint pain, weak when up. 1:35 chilling, H/A, muscle and joint pain. 3:45 diaphoric (sweating). Still have H/A, muscle and joint pain. 8:00PM taking in fluids and some food, still have H/A, muscle and joint pain through out night and next morning. 5/11/06 08:30 Up but weakness, fluids, food in, H/A, muscle and joint pain through out the day.  5/12/06: still have H/A and muscle and joint pain through out day. 5/14/06 Feeling better, occ H/A, left arm slightly sore. 5/15/06 feeling fine no H/A or pain.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: 2 month old developed fever to 103.4 within 24 hrs of receiving vaccines.
Sex: U
Vaccine: DTAP, HIBV, PNC
Symptoms: Hypersensitivity, Pyrexia, Rash erythematous
Clinical narrative: Had shots 5/1/06, ran fever for 2 days, 5/5/06 broke out red rash all over, 5/5/06 diagnosed with allergic reaction.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Unintended pregnancy
Clinical narrative: Info has been received from a health professional, through a mfr pregnancy registry, concerning a 26 year old white female tobacco user with no known drug allergies and a history of 3 previous pregnancies with 3 full-term births who on 6/8/04 and 7/9/04 was vaccinated, SC, with the 1st and second 0.5 ml doses, respectively, of varicella virus vaccine live. There was no concomitant therapy. The health professional reported that after the 2nd dose was administered, the pt thought she may have been pregnant. Unspecified medical attention was sought and a pregnancy test was administered which was (+). On 2/25/05, at 38 weeks gestation, the pt gave birth, vaginally, to a well male weighting 6 lbs 12 oz. The infant was normal and no congenital anomalies, complications or abnormalities were noted. The mother and infant did not have any adverse events. Follow-up info indicated that on 4/8/05, the infant developed congestion, a cough and green snot. On 4/15/05, a dx of upper respiratory tract infection was made. On 4/20/05, the infant's cough persisted coupled with eye drainage and nasal crusting. He was noted to be afebrile. At the time, it was felt that the infant was still suffering from a viral URI. Subsequently, the pt's viral URI resolved. No further info is available.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Joint tuberculosis, Menstruation irregular, Unintended pregnancy
Clinical narrative: Info and follow-up info has been received from an RN through a mfr pregnancy registry concerning a 19 year old pregnant Hispanic female with irregular periods who was given 2 doses of varicella virus vaccine live, a 1st vaccination was administered on 06/23/04 and the 2nd vaccination was administered on 8/5/04. Concomitant therapy included rifampin, start date 6/28/04 and stop date 8/5/04, 500mg daily "except for 2 days". Follow-up info reported that the indication for rifampin was "preventive therapy for positive PPD" (the date of (+) results was not provided). It was also noted that the pt used "en vits" (dates not specified). It was noted that the pt had never had varicella disease. The pt estimates that she is 1 1/2-2 months pregnant at this point. The RN reported the pt's estimated delivery date as 3/19/05. It was noted that the pt had no previous pregnancies. The pt was not tested for varicella antibodies before vaccination with varicella virus vaccine live. The had 2 ultrasounds the first one in August, 2004 for "dates" and the second ultrasound was routine, both studies were negative. It was noted that the pt will be going for genetic counseling as her sister has factor v disorder and cannot carry to term. Follow-up info confirmed the pt had factor 5 testing, which was negative. There was no maternal adverse event. It was noted that there was no local reaction at the vaccination site, and no symptoms of varicella or herpes zoster, post/vax. There was no product quality complaint reported. Follow-up info was received from an RN which reported that on 3/24/05, 41 weeks from lmp, the pt delivered a 7 60 8 gram, live born, normal male infant. It was noted the the pt had no illnesses or infections during her pregnancy and no concurrent medical conditions. It was also reported that there was no complication during the pregnancy or delivery: her labor was noted to last 24 hours and she delivered 18 hours after her water broke. There was no infection and no reconium on the infant. It was noted that the male infant did not show any feature of congenital varicella zoster syndrome. Info received on 3/28/05, mentioned the pt experienced the following adverse event: "positive PPD". No further info is available.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal, Unintended pregnancy
Clinical narrative: Info has been received from a physician and an RN, through a mfr pregnancy registry, concerning a 36 year old white female with no previous pregnancies who on 8/31/04, was vaccinated with the 2nd dose of varicella virus vaccine live. There was no concomitant therapy. The RN reported that the pt was pregnant at the time of vaccination (LMP=8/27/04, EDD=6/3/2005). Unspecified medical attention was sought and it was noted that the pt did not have a local injection site reaction, varicella symptoms or herpes zoster symptoms post/vax. On 11/16/04, an ultrasound was within normal limits. The physician reported that during pregnancy, the pt developed mild oligohydramnios and in 5/05, at 37 weeks gestation, developed pregnancy induced hypertension. No other infections or illnesses were noted during the pregnancy. On 5/18/05, at 37 5/7 weeks gestation, the pt gave birth to a live born normal female, weighing 7 lbs 11 oz. No complications were noted during labor/delivery. The infant had no congenital anomalies or any features of congenital varicella zoster syndrome. No further info is available.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Placental disorder
Clinical narrative: Info has been received through the mfr pregnancy registry from a health professional concerning a 16 year old Hispanic female with a history of chickenpox, no known allergies, and no previous pregnancies who on 7/30/04 was vaccinated with a dose of varicella virus vaccine live. At the time of vaccination, the pt was 8 1/2 weeks pregnant, with a LMP of 5/31/04. On 9/17/04, the pt started taking prenatal vitamins. On 10/1/04, a maternal serum alpha-fetoprotein test was performed and the results were within normal limits. On 10/22/04, an ultrasound was performed that showed a low-lying placenta but was within normal limits. It was unknown if the pt had al local reaction at the vaccination site or varicella and herpes zoster symptoms post/vax. There was no product quality complaint involved. Follow-up info from the health professional indicated that on 2/10/05, the pt had a live born, normal, female infant, described as slightly preterm at 36 4/7 weeks gestation. The baby weighed 6 lbs 3 oz. No other info was available at that time as the pt had not yet been seen for post partum visit. Additional info is not expected.
Age: 20.0
Sex: F
Vaccine: HEP, MMRV, VARCEL
Symptoms: Infection parasitic, Unintended pregnancy
Clinical narrative: Information has been received from a health professional through a Merck pregnancy registry concerning a 21 year old pregnant female, with a history of 2 full-term births, who on 7/13/04 was vaccinated with a dose of VARIVAX. Secondary concomitant therapies included a 0.5 ml dose of MMR II and a dose of RECOMBIVAX HB, also given on 7/31/04. An additional dose of RECOMBIVAX HB (manufacturer unknown) was given on 10-AUG-2004 and an additional dose of VARIVAX was given on 31-Aug-2004. Concomitant medications included prenatal vitamins from September 2004, 1 1000mg dose of Zithromax on 9/22/04 for the chlamydia infection and 1 125mg, IM, dose of Rocephin, 250 mg, on 9/22/04 for the chlamydia infection. Her LMP was 3/15/04 and her EDD was 12/20/04. The health professional reported that the "patient knew she was pregnant when vaccinated". The patient had ultrasounds on 10/1/04 and 12/1/04, to determine size and date and were both normal. Follow-up info from a health professional indicated that the patient had a healthy baby boy that was "4 months ago", on approximately 1/05. It was noted that the patient had an appointment schedules for this afternoon. Follow-up info from a physician indicated that the patient experienced a chlamydia infection during pregnancy which was diagnosed at the initial obstetrician visit. There was no complication during pregnancy, no complication during labor/delivery, and no diagnostic test during pregnancy on 12/28/04. 40 weeks and 5 days from her LMP, the patient gave birth to a normal, 3 lb 10 oz male, with no complication or abnormalities, and no feature of congenital varicella zoster syndrome. There was no product quality complaint involved. Additional info has been requested.
Age: 1.31
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning 2 adolescent pts who in 1997 were vaccinated with doses of varicella virus vaccine live. "Recently", in approximately, January, 2005, the pts experienced mild cases of chicken pox. The children were recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other info was available. Follow-up info was received regarding one of the pts, an 8 year old white male who on 12/9/97 was vaccinated with a dose of varicella virus vaccine live. It was reported that on 1/19/05, the child developed "typical dewdrop on rose petal type lesions in various stages of development". There were approximately 15 lesions. The pt recovered. No additional info is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an RN concerning a pt between the age of 6 to 8 years, who at the time of the 1st birthday, was vaccinated with a dose of varicella virus vaccine live. Between 9/04 and 12/04, the pt developed mild breakthrough cases of varicella. Unspecified medical attention was sought. There was no product quality complaint involved. No further info is expected.
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Info has been received from a pharmacist concerning a male child who "tow to three weeks ago" in approximately 3/05, was vaccinated with a dose of varicella virus vaccine live. "Shortly after vaccination", the pt developed "about" 15 chickenpox lesions. Subsequently, the pt recovered. It was unknown if medical attention was sought. There was no product quality complain involved. Additional info has been requested.
Age: 35.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Rash
Clinical narrative: Info has been received from a consumer concerning a 35 year old male with no allergies who on 3/17/05 was vaccinated with the 1st dose of varicella virus vaccine live. Concomitant therapy included aspirin. The consumer reported that on 3/17/05, 1 hour after vaccination, the pt developed redness at the injection site and a rash on his neck. Unspecified medical attention was sought but no laboratory/diagnostic tests were performed. At the time of this report, the pt's redness at the injection site and rash on his neck persisted as it was noted to be "getting worse". No further info is available.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Ear pain, Otitis media, Pruritus, Rash papular
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 5 year old female who in June 1999, was vaccinated with a 0.5 ml dose of VARIVAX (Merck). The NP reported that in March 2005, the patient developed an ear ache and was diagnosed with otitis media. The patient was seen by the NP and treated with AMOXIL. The patient was not getting better and was changed to AUGMENTIN X 2 days. Seven days later, the patient subsequently developed an itchy papular rash from pin point to eraser head size all over. The NP indicated that he was unsure if the patient's rash was a drug reaction vs. varicella. Additional info has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash papular
Clinical narrative: Info has been received from a physician concerning an 8 year old white female twin student who on 9/29/97, was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 2/8/05, the pt developed an itchy, papulovesicular rash at different stages all over her trunk and face. Medical attention was not sought and no laboratory/diagnostic tests were performed. Subsequently, the pt recovered from the itchy papulovesicular rash. No further info is available.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning a 6 year old male who at 12 months of age, was vaccinated with a dose of varicella virus vaccine live. It was reported that the child experienced 50 or more pox and had no vesicles. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info has been requested. Additional info has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood human chorionic gonadotropin negative, Blood human chorionic gonadotropin positive, Delivery, Drug exposure during pregnancy, Laboratory test abnormal
Clinical narrative: Info has been received through the mfr pregnancy registry from a health professional concerning a 19 year old female who on 1/25/05 was vaccinated with a dose of varicella virus vaccine live, after an initial pregnancy test came back negative. The pt had another pregnancy test taken, 1 week after vaccination during an exam and that came back positive. The pt then followed up with an obstetrician from another practice on 3/10/05 when it was determined that she was 10-12 weeks pregnant. It was noted that conception was in 12/04. No physical symptoms were reported. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Follow-up info from a health professional indicated that the pt will be having an ultrasound because the doctor feels that she is not gaining weight. Additional info has been requested. Follow-up information from a health professional indicated that the patient delivered a normal healthy newborn on Sep 29, 2005.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Ultrasound scan, Unintended pregnancy, Weight gain poor
Clinical narrative: Info has been received through the mfr pregnancy registry from a health professional concerning a 19 year old female who on 1/25/05 was vaccinated with a dose of varicella virus vaccine live, after an initial pregnancy test came back negative. The pt had another pregnancy test taken, 1 week after vaccination during an exam and that came back positive. The pt then followed up with an obstetrician from another practice on 3/10/05 when it was determined that she was 10-12 weeks pregnant. It was noted that conception was in 12/04. No physical symptoms were reported. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Follow-up info from a health professional indicated that the pt will be having an ultrasound because the doctor feels that she is not gaining weight. Additional info has been requested. Follow-up information from a health professional indicated that the patient delivered a normal healthy newborn on Sep 29, 2005.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received through the mfr pregnancy registry from a 44 year old female who in 11/93, was vaccinated with an "adult dose" of varicella virus vaccine live while she was 8 months pregnant. Subsequently, on 11/26/93, she reported a breakthrough of chicken pox. The report indicates "blood test" for lab diagnostics studies performed. Unspecified medical attention was sought. There was no concomitant medication. Outcome unknown. There was no product quality complaint involved. Follow-up info has been received from a nurse indicating that the pt's office does not administer varicella virus vaccine live and they only draw titers for serostatus. If the pt needed the vaccine they would be referred to the pediatrician's office. The reporter also indicated that they would not have treated the pt if she was pregnant and that she would have been obtaining care from her prenatal physician. Additional info is expected.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Info has been received from a health professional concerning a 7 year old male with asthma and no known drug reactions of allergies who on 6/17/98 (also reported as 6/12/98) was vaccinated in the left leg with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 3/20/05, the pt developed a rash on his back and legs of less than 50 lesions. Unspecified medical attention was sought and the treatment was comfort measures and cetirizine hydrochloride (Zyrtec), calamine lotion and Aveeno baths. At the report, the pt had not recovered. There was no product quality complaint involved. Follow-up info indicated that on 3/22/05, the pt was seen in the doctor's office with a scattered papular erythematous rash, some with vesicles which started on 3/20/05. The pt never had a fever. The physician told the pt's father to just watch it and if it itches, to use desloratadine (Clarinex) syrup or cetirizine hydrochloride (Zyrtec). On 4/1/05, the pt's father reported that the pt recovered after seven to ten days and he had a total of 12 lesions. It was reported that the pt had no adverse events following prior vaccination. No further info was expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus
Clinical narrative: Info has been received from a physician concerning an 8 year old white male with asthma and allergies who on 4/26/99 was vaccinated SC with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. The "week of 3/14/05", the pt developed a case of breakthrough varicella with itching, no fever and 40 pox covering his body. It was reported that the pt's rash was consistent with mild varicella. Unspecified medical attention was sought. No m3edication was given. There was no product quality complaint involved. Subsequently, the pt recovered. Additional info is not expected.