chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, UNK
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Pyrexia, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 2-month-old female who on 09-MAR-2007 was vaccinated PO with the first dose of Rotateq (lot number not provided). Concomitant vaccinations administered on that same day included "all the required shots for a 2-month-old." The patient was noted to be asymptomatic on the day of vaccination. The RN reported that , within 24 hours after vaccination, on approximately 10-MAR-2007, the patient developed a fever and diarrhea. On 12-MAR-2007, the patient presented to the office where she tested positive for rotavirus. The RN noted that the patient had been in daycare where Influenza A had been "going around." The patient was treated with Lactobacillus acidophilus (+) Lactobacillus bulgarious. In March 2007, the patient recovered. Additional information has been requested. Information has been received from a registered nurse concerning a 8-week-old female with a milk-soy protein allergy and gastrooesophageal reflux disease who on 09-MAR-2007 was vaccinated PO with the first dose of ROTATEQ (lot #656189/1239F). Concomitant vaccinations administered in that same day included the first IM dose in the right thigh of PEDIARIX (lot # AC21B066AA), the first IM dose in the left thigh of Hib conj vaccine (lot # 654677/1124F) and the first IM dose on the left thigh PREVNAR (Lot # B08681D). The was no illness at the time of vaccination. The patient was noted to be asymptomatic on the day of vaccination. The RN reported that within 24 hours after vaccination, on the evening of 0+9-MAR-2007, the patient developed a fever, vomiting, and diarrhea. PREVACID was restarted. On 12-MAR-2007, the patient presented to the office and LACTINEX was started. A hemoccult test of the patient's stool was negative. On 13-MAR-2007, Alimentum formula was started. On 14-MAR-2007, the patient tested positive for rotavirus. The RN noted that the patient had been in daycare where INFLUENZA A had been "going around." On 15-MAR-2007, the patient recovered. O n15-MAR-2007, the patient received her "4 months shots". No adverse events were noted. No further information is available.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, UNK
Symptoms: Diarrhoea, Exposure to communicable disease, Gastroenteritis rotavirus, Pyrexia, Rotavirus test positive
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 2-month-old female who on 09-MAR-2007 was vaccinated PO with the first dose of Rotateq (lot number not provided). Concomitant vaccinations administered on that same day included "all the required shots for a 2-month-old." The patient was noted to be asymptomatic on the day of vaccination. The RN reported that , within 24 hours after vaccination, on approximately 10-MAR-2007, the patient developed a fever and diarrhea. On 12-MAR-2007, the patient presented to the office where she tested positive for rotavirus. The RN noted that the patient had been in daycare where Influenza A had been "going around." The patient was treated with Lactobacillus acidophilus (+) Lactobacillus bulgarious. In March 2007, the patient recovered. Additional information has been requested. Information has been received from a registered nurse concerning a 8-week-old female with a milk-soy protein allergy and gastrooesophageal reflux disease who on 09-MAR-2007 was vaccinated PO with the first dose of ROTATEQ (lot #656189/1239F). Concomitant vaccinations administered in that same day included the first IM dose in the right thigh of PEDIARIX (lot # AC21B066AA), the first IM dose in the left thigh of Hib conj vaccine (lot # 654677/1124F) and the first IM dose on the left thigh PREVNAR (Lot # B08681D). The was no illness at the time of vaccination. The patient was noted to be asymptomatic on the day of vaccination. The RN reported that within 24 hours after vaccination, on the evening of 0+9-MAR-2007, the patient developed a fever, vomiting, and diarrhea. PREVACID was restarted. On 12-MAR-2007, the patient presented to the office and LACTINEX was started. A hemoccult test of the patient's stool was negative. On 13-MAR-2007, Alimentum formula was started. On 14-MAR-2007, the patient tested positive for rotavirus. The RN noted that the patient had been in daycare where INFLUENZA A had been "going around." On 15-MAR-2007, the patient recovered. O n15-MAR-2007, the patient received her "4 months shots". No adverse events were noted. No further information is available.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old female with no known allergies or pertinent medical history who on 27-Mar-2007 was vaccinated (in what the pharmacist believed was the left upper arm), with a 0.65 ml dose of zoster vaccine (Oka/Merck). There was no concomitant medication. The next day, on 28-Mar-2007 the patient developed a very large rash at the injection site, a low grade fever and was not feeling very well. The patient presented to her doctor's office where the physician marked the rash site for observation, there was no treatment. There were no lab tests performed. At the time of the report the patient was "feeling a little better." There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Initial and follow-up information has been received from a pharmacist concerning a 78 year old female with no known allergies, rheumatoid arthritis, high blood pressure, hypothyroidism and hormone replacement (also reported as no medical history) who on 22-MAR-2007 at 15:15 (also reported as 27-MAR-2007) was vaccinated SC in the left arm, with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 656607/0163U). Concomitant therapy included methotrexate, lisinopril (manufacturer unknown), folic acid, atenolol, LEVOXYL, PREMARIN. There was no illness at the time of vaccination. Approximately 24 hours after vaccination, on 23-MAR-2007 at 18:00 (also reported as 28-MAR-2007) the patient developed a very large rash at the injection site, a low grade fever of 101 degrees and was not feeling very well. It was reported that the rash involved the entire upper arm, expanding from the elbow to the top of the arm. The patient presented to her doctor's office where the physician marked the rash site for observation. The patient was started on an antibiotic and a steroid taper 2 days after the vaccine (also reported as there was no treatment). On 02-APR-2007 the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information is not expected. This is a consolidation of two reports concerning the same patient. It has been determined that WAES # 0704USA02828 is a duplicate of WAES # 0703USA05617. Therefore, WAES # 0704USA02828 is being deleted from our files and the reports consolitated into WAES # 0703USA05617.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site rash, Malaise, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old female with no known allergies or pertinent medical history who on 27-Mar-2007 was vaccinated (in what the pharmacist believed was the left upper arm), with a 0.65 ml dose of zoster vaccine (Oka/Merck). There was no concomitant medication. The next day, on 28-Mar-2007 the patient developed a very large rash at the injection site, a low grade fever and was not feeling very well. The patient presented to her doctor's office where the physician marked the rash site for observation, there was no treatment. There were no lab tests performed. At the time of the report the patient was "feeling a little better." There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Initial and follow-up information has been received from a pharmacist concerning a 78 year old female with no known allergies, rheumatoid arthritis, high blood pressure, hypothyroidism and hormone replacement (also reported as no medical history) who on 22-MAR-2007 at 15:15 (also reported as 27-MAR-2007) was vaccinated SC in the left arm, with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 656607/0163U). Concomitant therapy included methotrexate, lisinopril (manufacturer unknown), folic acid, atenolol, LEVOXYL, PREMARIN. There was no illness at the time of vaccination. Approximately 24 hours after vaccination, on 23-MAR-2007 at 18:00 (also reported as 28-MAR-2007) the patient developed a very large rash at the injection site, a low grade fever of 101 degrees and was not feeling very well. It was reported that the rash involved the entire upper arm, expanding from the elbow to the top of the arm. The patient presented to her doctor's office where the physician marked the rash site for observation. The patient was started on an antibiotic and a steroid taper 2 days after the vaccine (also reported as there was no treatment). On 02-APR-2007 the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information is not expected. This is a consolidation of two reports concerning the same patient. It has been determined that WAES # 0704USA02828 is a duplicate of WAES # 0703USA05617. Therefore, WAES # 0704USA02828 is being deleted from our files and the reports consolitated into WAES # 0703USA05617.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Body temperature increased, Malaise, Pyrexia, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old female with no known allergies or pertinent medical history who on 27-Mar-2007 was vaccinated (in what the pharmacist believed was the left upper arm), with a 0.65 ml dose of zoster vaccine (Oka/Merck). There was no concomitant medication. The next day, on 28-Mar-2007 the patient developed a very large rash at the injection site, a low grade fever and was not feeling very well. The patient presented to her doctor's office where the physician marked the rash site for observation, there was no treatment. There were no lab tests performed. At the time of the report the patient was "feeling a little better." There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Initial and follow-up information has been received from a pharmacist concerning a 78 year old female with no known allergies, rheumatoid arthritis, high blood pressure, hypothyroidism and hormone replacement (also reported as no medical history) who on 22-MAR-2007 at 15:15 (also reported as 27-MAR-2007) was vaccinated SC in the left arm, with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 656607/0163U). Concomitant therapy included methotrexate, lisinopril (manufacturer unknown), folic acid, atenolol, LEVOXYL, PREMARIN. There was no illness at the time of vaccination. Approximately 24 hours after vaccination, on 23-MAR-2007 at 18:00 (also reported as 28-MAR-2007) the patient developed a very large rash at the injection site, a low grade fever of 101 degrees and was not feeling very well. It was reported that the rash involved the entire upper arm, expanding from the elbow to the top of the arm. The patient presented to her doctor's office where the physician marked the rash site for observation. The patient was started on an antibiotic and a steroid taper 2 days after the vaccine (also reported as there was no treatment). On 02-APR-2007 the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information is not expected. This is a consolidation of two reports concerning the same patient. It has been determined that WAES # 0704USA02828 is a duplicate of WAES # 0703USA05617. Therefore, WAES # 0704USA02828 is being deleted from our files and the reports consolitated into WAES # 0703USA05617.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Depression, Dermatitis, Fatigue, Pain, Pruritus
Clinical narrative: Body rash and dermatitis with pain and fatigue extreme, depretion, pruritis
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Body rash and dermatitis with pain and fatigue extreme, depretion, pruritis
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 16 year old female who was seen in a clinic for a migraine, and subsequently, was vaccinated IM with the first dose of GARDASIL. It was reported that the patient developed seizures within 15-20 minutes of vaccination. The clinic called 911, and the nurse practitioner "believed" the patient was taken to the emergency room, although, it was unknown if the patient was hospitalized. It was also reported that the patient had no prior history of seizures, and that the patient's outcome was unknown. Upon internal review, the patient's seizure was considered to be an other important medical event. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse for the Pregnancy registry for Gardasil concerning a 26 year old female who on 20-DEC-2006 was vaccinated IM with the second 0.5 mL dose of Gardasil. The patient was vaccinated with the  first 0.5 mL dose Gardasil (lot # 653937/0637F) on 27-OCT-2006. Concomitant therapy included hormonal contraceptives (unspecified). In January 2007, the patient became pregnant. In March 2007, the patient had a miscarriage at 8 weeks gestation. The patient sought unspecified medical attention. Subsequently, the patient recovered. Upon internal review, the patient's miscarriage was considered to be an other important medical event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Blood culture, Body temperature increased, Cellulitis, Erythema
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with a prednisolone allergy, asthma and a history of pneumonia who on 13-NOV-2006 was vaccinated IM into the left arm with a dose of Pneumovax 23. Concomitant therapy included Lexapro. That evening at 19:00, the patient presented to the physician office and complained of achiness in her left arm. On 15-NOV-2007, the patient began to experience prodromal symptoms including: generalised body aches, fever of 102 F, low back pain, headaches, inability to extend her arm without pain, cellulitis and erythema of the left arm. The patient was treated with IV Rocephin. It was reported that they were not sure if the patient experienced an allergic reaction or cellulitis. On 15-NOV-2006, a CBC was performed and WBC was 20,000 and a chem panel was performed (results not provided). On 16-NOV-2006, a CBC and blood cultures were performed (results not provided), and a WBC of 15,0000. On 18-NOV-2006 the patient was seen with minimal erythema. On 20-NOV-2006, the patient recovered. No product quality complaint was involved. Achiness in arm, body aches, fever of 102 F, back pain, headaches, cellulitis, inability to extend arm and erythema of the left arm were considered to be other important medical events. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Headache, Hypokinesia, Injected limb mobility decreased, Joint range of motion decreased
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with a prednisolone allergy, asthma and a history of pneumonia who on 13-NOV-2006 was vaccinated IM into the left arm with a dose of Pneumovax 23. Concomitant therapy included Lexapro. That evening at 19:00, the patient presented to the physician office and complained of achiness in her left arm. On 15-NOV-2007, the patient began to experience prodromal symptoms including: generalised body aches, fever of 102 F, low back pain, headaches, inability to extend her arm without pain, cellulitis and erythema of the left arm. The patient was treated with IV Rocephin. It was reported that they were not sure if the patient experienced an allergic reaction or cellulitis. On 15-NOV-2006, a CBC was performed and WBC was 20,000 and a chem panel was performed (results not provided). On 16-NOV-2006, a CBC and blood cultures were performed (results not provided), and a WBC of 15,0000. On 18-NOV-2006 the patient was seen with minimal erythema. On 20-NOV-2006, the patient recovered. No product quality complaint was involved. Achiness in arm, body aches, fever of 102 F, back pain, headaches, cellulitis, inability to extend arm and erythema of the left arm were considered to be other important medical events. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test, Pain, Pain in extremity, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with a prednisolone allergy, asthma and a history of pneumonia who on 13-NOV-2006 was vaccinated IM into the left arm with a dose of Pneumovax 23. Concomitant therapy included Lexapro. That evening at 19:00, the patient presented to the physician office and complained of achiness in her left arm. On 15-NOV-2007, the patient began to experience prodromal symptoms including: generalised body aches, fever of 102 F, low back pain, headaches, inability to extend her arm without pain, cellulitis and erythema of the left arm. The patient was treated with IV Rocephin. It was reported that they were not sure if the patient experienced an allergic reaction or cellulitis. On 15-NOV-2006, a CBC was performed and WBC was 20,000 and a chem panel was performed (results not provided). On 16-NOV-2006, a CBC and blood cultures were performed (results not provided), and a WBC of 15,0000. On 18-NOV-2006 the patient was seen with minimal erythema. On 20-NOV-2006, the patient recovered. No product quality complaint was involved. Achiness in arm, body aches, fever of 102 F, back pain, headaches, cellulitis, inability to extend arm and erythema of the left arm were considered to be other important medical events. Additional information has been requested.
Age: 0.54
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: CSF test, Culture, Cyanosis, Dyspnoea, Full blood count
Clinical narrative: About 3hrs after 6 month vaccines administered pt had some difficulty breathing. Color changes and tremors. Transported via EMS and given O2.  04/17/2007 VAERS report received with records attached for a 2 night hospital admission 03/29-31/2007 for c/o a reported episode of decreased responsiveness and dusky color witnessed by the infant's grandmother 2 hours after receiving vaccinations.  Grandmother also reported shaking.  Child was transfered to the hospital via EMS.  O2 and Albuterol nebs were admisnitered in the field with improvement in symptoms. PE: Temp 103.1F Rectally. 2/6 systolic ejection murmur.  Lung sounds (+) for upper airway noises otherwise WNL. No further spells during hospitalization.  To be followed as an outpatient. Discharge DX:  1) Spell.  2) Fever with Upper Respiratory Sx.  3) Possible Seizure.
Age: 0.54
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Oxygen supplementation, Skin discolouration, Tremor, Virus culture
Clinical narrative: About 3hrs after 6 month vaccines administered pt had some difficulty breathing. Color changes and tremors. Transported via EMS and given O2.  04/17/2007 VAERS report received with records attached for a 2 night hospital admission 03/29-31/2007 for c/o a reported episode of decreased responsiveness and dusky color witnessed by the infant's grandmother 2 hours after receiving vaccinations.  Grandmother also reported shaking.  Child was transfered to the hospital via EMS.  O2 and Albuterol nebs were admisnitered in the field with improvement in symptoms. PE: Temp 103.1F Rectally. 2/6 systolic ejection murmur.  Lung sounds (+) for upper airway noises otherwise WNL. No further spells during hospitalization.  To be followed as an outpatient. Discharge DX:  1) Spell.  2) Fever with Upper Respiratory Sx.  3) Possible Seizure.
Age: 40.0
Sex: M
Vaccine: TTOX
Symptoms: Body temperature increased, Brain damage, Jaw disorder, Joint lock, Throat irritation
Clinical narrative: IV had thick covered throat covered throat/locked up Jaw, Locked up joints/Fingers/Toes/Legs/arms. Many high temperatures, part brain damage as well. Through the last 35 years.  04/17/2007 Spoke to reporter/patient who reports that the current AE was rash.  Pt. states he was hospitalized for "gall bladder surgery" where the rash was noted.  Box 8 data does not relate to current AE per pt.  Box 8 data was related to past reactions, as was info in Box 7.   04/17/2007 MR received. Pre-op H&P dated 3/05/2007 for upcoming cholecystectomy. Tetanus booster given. Operative and path reports report done 3/7/07 included. 04/27/2007 MR received for post op visit (03/21/07)with Assessment: Satisfactory post-op course.  No c/o other than diarrhea.   No other records available per pt./reporter.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Rash macular
Clinical narrative: Macular, erythematous, rash, started on trunk and spread to involve entire body except face at time of exam. No fever or other symptoms.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swelling of deltoid, extending around upper arm approximately 6cm x 5cm red and swollen.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vertigo, Vomiting
Clinical narrative: Nausea, vomiting, vertigo lasting four days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cough, Dyspnoea, Erythema, Stridor, Swelling
Clinical narrative: 5 minutes after receiving vaccine she developed full body erythema, swelling and urticaria. She also started to developed mild stridor, cough and increased work of breathing. She was given Benadryl. IM epinephrine and transferred by squad to the hospital.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Urticaria
Clinical narrative: 5 minutes after receiving vaccine she developed full body erythema, swelling and urticaria. She also started to developed mild stridor, cough and increased work of breathing. She was given Benadryl. IM epinephrine and transferred by squad to the hospital.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Torticollis
Clinical narrative: Gardasil #1 received 4/9/07 woke up 4/10/07 with acute torticoillis.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 3" x 2 1/4" light red outer ring with 1" x 1 1/4" dark red warm firm center on L outer thigh. To give Benadryl Q 6-8 hours per swelling/itching.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient describes an area of erythema and swelling approximately 1" wide x 1 1/2" long with itching at the site.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 103.7 night of immunizations and next day.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Cellulitis, Erythema, Rash generalised, Rash papular, Rash pustular
Clinical narrative: 1. Erythema - suspected cellulitis of left arm started 9days after vaccination - started a Keflex. 2. Diffuse papular/pustular rash started 1 days after vaccination suspected generalized vaccina - also 1cm ulcer on tongue and noted with generalized rash.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Tongue ulceration
Clinical narrative: 1. Erythema - suspected cellulitis of left arm started 9days after vaccination - started a Keflex. 2. Diffuse papular/pustular rash started 1 days after vaccination suspected generalized vaccina - also 1cm ulcer on tongue and noted with generalized rash.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injected limb mobility decreased, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 3 days after vaccine administered, pt presented to the office with area of cellulitis surrounding injections site. Patient c/o pain since receiving shot than began to turn red and swollen. Presented with 13x13 cm area surrounding site with decreased ROM of elbow.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Induration, Injection site erythema, Injection site pain
Clinical narrative: Started with redness around injection site, examined office approximately 72 hours. 9cm x 8cm indurated/ red. Mildly tender area, left upper arm at site of IPV injection.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Muscle swelling, Myalgia, Paraesthesia, Pyrexia, Rash erythematous
Clinical narrative: Muscle marked by swollen and tender with movement, early fever and distal extremity erythematous rash. Rash was confluent and blanchable in all 4 extremities. Rash and fever subsided but pain and swelling in muscle have persisted for several days. No cellulitis noted on exam. No other SX prior to today with some tingling in his arm.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Rash papular, Rash pruritic, Rash vesicular
Clinical narrative: Papular vesicular pruritic rash began 1 week after receiving Varivax booster.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: L thigh red, swollen, hot, 7 1/2 cm x 10cm (area)
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Tdap given 4/12 and next day. Patient with F to 102.6, HA and nausea. Sx care at home recommended for virus vs vaccine rexn.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: The day after receiving Tdap vaccine, pt c/o soreness, pain, erythema, edema and arm warm to touch. Seen in clinic 2 days later with same symptoms. Was taking Tylenol with no relief. Referred to MD for evaluation.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever with vaccination 101.9 (R)
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever developed after vaccine administered ten hr later. Shot 4/10/07 2PM fever at 8 pm.
Age: 1.1
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, MMRV, PNC
Symptoms: Body temperature increased, Rash
Clinical narrative: Patient had 102 temp on 2-4-07. Tylenol given temp decreased. 2-5-07 mother report multiple red spots. 2-7-07 mom brought child into health dept. Noted multiple red spots in hair, face, arms, trunk, legs.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Expired drug administered
Clinical narrative: #2 MMR administered expired lot # MSD 0377R (3/24/07) couldn't update in LINKS
Age: 0.92
Sex: F
Vaccine: DTAP, FLU3, IPV, PNC
Symptoms: Anorexia, Furuncle, Pyrexia, Skin lesion
Clinical narrative: March 16, 2007-Mom called and stated child had been running fever since Wednesday 03-14-07 as high as 103.9. Instructed to contact MD and I would follow up with her on Monday March 19, 2007. March 19, 2007-Phoned mother back and she spoke with MD and he said it was o.k. to give future immunizations. Mother went on to report that child was still running fever since 03-14-07 ranging from 100.5-103.9. She was giving the child Tylenol & Ibuprofen. The child also has a loss of appetite. She also reported that she noted a red bump on the child's right buttock near anus the day she received immunizations but the child wasn't running fever then and today the bump was now formed into a boil and the child is unable to sit down. She was waiting for the MD's office to call her back with an appointment for the child. March 21, 2007-Spoke with mother and child is not on antibiotics by mouth and topical for boil on right buttock and MD said it is not related to immunizations.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Vomiting
Clinical narrative: 4-12-07 Mother called office. Had vaccines 4-11-07. Vomited x 1 4-12-07 during the night. Mom concerned vomiting was side effect of one of the shots
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Induration, Injection site rash, Injection site reaction, Rash erythematous, Rash vesicular
Clinical narrative: Patient developed an indurated, erythematous, painful rash involving mast of the upper outer arm. In central, vesicular rash at the injection site left arm.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Mother stated that child has swelling on the left arm from the shoulder to the elbow. Symptoms noted on 3/27/07 in the morning. Mother added that the site was feverish. I informed mom to call her child's physician.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC
Symptoms: Rash erythematous, Rash papular, Rash vesicular
Clinical narrative: Eryth pap lesions with hint of vesicular appearance on abd. Scattered almost confluently in center abd, then thickly on trunk, forehead, sparsly on scalp and extremities.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Oral contraception, Pruritus, Rash, Rash macular
Clinical narrative: on 3/22/07 broke out in rash on right arms, upper chest and neck itchy. on 3/23/07-examined and very faint macular rash on arms, neck, upper trunk, not urticaria
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Pruritus, Rash papular
Clinical narrative: papula rash-Both thighs, antihistamine/cream if itch continues
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood pressure normal, Fall, Head injury, Heart rate, Neurological examination normal
Clinical narrative: Sitting on exam table , received vaccines Gardasil and Menactra. Got down from exam table, stood up and fell forward, hitting forehead on the wall. Nurse pivoted her onto a chair, sitting position. "Patient's eyes were open, back arched, arms straight and posturing" x approximately 3 seconds. Relaxed - still staring, not alert. Nurse and medical student placed her on exam table reclining.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Posturing, Staring
Clinical narrative: Sitting on exam table , received vaccines Gardasil and Menactra. Got down from exam table, stood up and fell forward, hitting forehead on the wall. Nurse pivoted her onto a chair, sitting position. "Patient's eyes were open, back arched, arms straight and posturing" x approximately 3 seconds. Relaxed - still staring, not alert. Nurse and medical student placed her on exam table reclining.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood pressure orthostatic, Dizziness, Fall, Feeling hot, Haemoglobin
Clinical narrative: Patient had lab work done 1st (hemoglobin), then received vaccines-Gardasil and Menactra left exam room, walked into waiting room and told mother she felt "hot and dizzy"; "fell over, hit head, eyes remained and open, head arched back, arms shaking. "Episode over within 1-2 minutes.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Head injury, Heart rate, Posture abnormal, Tremor
Clinical narrative: Patient had lab work done 1st (hemoglobin), then received vaccines-Gardasil and Menactra left exam room, walked into waiting room and told mother she felt "hot and dizzy"; "fell over, hit head, eyes remained and open, head arched back, arms shaking. "Episode over within 1-2 minutes.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a physician concerning a patient (age and sex not reported) who on unspecified dates was vaccinated with the first and second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot # not provided). It was reported that it had been 11 weeks since the second dose and the third dose had not yet been administered. No symptoms have been reported. Additional information has been requested
Age: 4.0
Sex: F
Vaccine: DPP, HIBV, IPV, RV5
Symptoms: Aspiration
Clinical narrative: Information has been received from a physician concerning a 4.5 month old female with on drug allergies who at the end of December 2006, was vaccinated PO with the first 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 diphtheria toxiod (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of Hib conj vaccine (OMPC) (manufacturer unknown). The physician reported that in late December 2006, shortly after the first dose, the patient aspirated. It was noted that the patient had a full bottle of formula prior to vaccination administration. Unspecified medical attention was sought. No laboratory/diagonostic tests were preformed. Subsequently, the patient recovered while on therapy. The physician noted that, at the next recommended interval, the second 2.0 mL dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) was given with no issues. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a physician concerning a male (age not reported) who in November 2006, was vaccinated with his first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). Four months later, the patient received his second dose. No problems were reported. Additional information has been requested. 08/31/07 This is in follow-up to report(s) previously submitted on 4/13/2007. No additional information is available.
Sex: U
Vaccine: RV5
Symptoms: Abdominal rigidity, Bowel movement irregularity
Clinical narrative: Information has been received from a consumer concerning her child was vaccinated PO with a first 2 ml dose of Rotateq (human-bovine). Subsequently the patient experienced a distinctive hard belly and had not had a bowel movement in 3 days. Unspecified medical attention was sought. Additional information has been requested. 29-OCT-2009 Follow-up information indicated that it was "not an anticipation". Additional information is not expected.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Bowel movement irregularity
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 month old female with no medical history or allergies who on 03 Jan 2007 was vaccinated with an oral dose of Rotateq (human bovine) (lot #655484/1032F). On 10 Jan 2007, one week after vaccination, the patient developed decreased bowel movements. Medical attention was sought. No laboratory tests were performed. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: DTAP, HIBV, RV5
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a physician concerning a two 6 week old patients were vaccinated with a dose of Rotateq (human-bovine). Suspect vaccination administered that day included Pediarix and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Subsequently, one day after vaccination, the patients developed a fever of 101F. The temps came down and were back to normal within 24 hours. Unspecified medical attention was sought. Subsequently, the patient recovered. Attempt are being made to obtain additional identifying information to distinguish the patients mentioned in this report. Additional information will be provided if available.
Age: 0.38
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a nurse concerning a male child with a history of laryngomalcia who on 27 Sep 2006 was vaccinated with his first dose of Rotateq (Lot# 655050/0778F) and his second dose of Rotateq (Lot# 654489/0941F) (date unspecified). "About a week after the second dose", the patient developed vomiting and diarrhea. On 26 Feb 2007, the patient had a positive lab screen for rotavirus. On an unspecified date, the patient recovered. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007.  Follow-up information has been received from a physician concerning a 21 week old male who was vaccinated with first dose of ROTATEQ on 27-NOV-2006 (previously reported as 27-SEP-2006), second dose on 12-FEB-2007, and third dose on 02-APR-2007.  Concomitant vaccines included Hib conj vaccine (unspecified carrier), PREVNAR, and PEDIARIX.  The patient was also vaccinated on 29-SEP-2006 with hepatitis B vaccine (unspecified).  On 27-FEB-2007 the patient experienced positive lab screen for rotavirus, vomiting and diarrhea which lasted approximately 4 days, the patient's required a doctor visit.  The patient's outcome was reported as recovered.  Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 14 week old male who was vaccinated with a first dose of Rotateq. No adverse symptoms were reported. 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: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a health professional concerning a 2 patients (twins) who were vaccinated with a first, second and third dose of Rotateq on 18 Oct 2006, 14 Dec 2006 and in March 2007. The third dose was administered greater than ten weeks after the second dose. No adverse experience were related to this event. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a health professional concerning a 4 month old patient who was vaccinated with a 2ml PO first dose of Rotateq. There was no adverse event. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with a dose of Rotateq. The physician reported that, about one week after being vaccinated, the patient developed severe diarrhea. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested. 08/31/07 This is in follow-up to report(s) previously submitted on 4/13/2007. No further information is available.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 16 week old twin (sex not reported) who on 06 Mar 2007 was vaccinated orally with the first dose of Rotateq. At four months of age the child received the first dose of Rotateq. No further information is available. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a nurse concerning a 14 week male who on 01 Mar 2007 was vaccinated with his first oral dose of Rotateq (Lot# 1392F). The nurse reported that the patient received his "1st dose of Rotateq after 12 weeks of age". No adverse event was reported. No further information was provided. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 4 month old male who was vaccinated with the first dose of Rotateq. It was unknown if medical attention was sought. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 20 week old male who on 07 Dec 2006, at 7 weeks old, was vaccinated with the first dose of Rotateq. On 08 Mar 2007, 13 weeks after receiving the first dose, the patient was vaccinated with the second dose of Rotateq. Unspecified medical attention was sought. Additional information has been requested.
Age: 0.24
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Occult blood positive, Rotavirus test positive
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning an approximately 13 week old male with a history of loose stools and no drug allergies who on 28 Feb 2007 was vaccinated with the first dose of Rotateq (Lot# 654248/0577F). The NP reported that on approximately 07 Mar 2007, the patient developed looser stools and has a positive stool sample for rotavirus. Unspecified medical attention was sought. A stool occult blood test was also performed (results not provided). At the time of this report, the patient's rotavirus persisted. Additional information has been requested. 06/01/2007 Information has been received from a nurse practitioner (NP) concerning a 13-week-old (previously reported as approximately 13 weeks) male with reactive airway disease, a history of loose stools and no drug allergies who on 28-FEB-2007 was vaccinated PO with the first dose of ROTATEQ (Lot #654248/0577F). Concomitant vaccinations administered on that same day included the first IM dose in the right anterior thigh of PEDIARIX (Lot #AC21B084BA), the first IM dose in the right anterior thigh of PEDVAXHIB(MSD) (Lot #654397/1014F) and the first IM dose in the left anterior thigh of PREVNAR (Lot #B362583). Other concomitant drug therapy included albuterol. The NP reported that on 04-MAR-2007 (previously reported as approximately 07-MAR-2007), the patient developed looser stools up to 3x/day. Unspecified medical attention was sought. On 07-MAR-2007, the patient's stool sample was positive for rotavirus. A stool occult blood test was negative and stool cultures were normal. The patient recovered after a few days. Additional information is not expected.
Age: 0.35
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a physician concerning a 4-month-old patient who on 07-MAR-2007 was vaccinated PO with the first 2.0 mL dose of Rotateq. It was unknown if medical attention was sought. The patient had not developed an adverse event. Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 9-month-old male who on 26-SEP-2006 was vaccinated PO with a 2.0 mL dose of Rotateq (Lot # 654392/0578F). The physician reported that on 06-MAR-2007, the patient tested positive for rotavirus. It was noted that blood tests were also performed (results not provided). Unspecified medical attention was sought. In March 2007, the patient recovered. Additional information has been requested.
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse (RN) concerning a patient who on 09 Mar 2007 was vaccinated PO with a dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of poliovirus vaccine inactivated (unspecified), a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of Comvax and a dose of Prevnar. The RN reported that on 09 Mar 2007, the patient vomited as the dose of Rotateq was being administered. Unspecified medical attention was sought and no other symptoms were noted. In March 2007, the patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007.  Follow-up information received from the nurse who reported that there "was adverse reaction involved with the patient."  No further information was available.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6-month-old female who on 26-OCT-2006 was vaccinated PO with the first 2.0 mL dose of Rotateq. On 26-FEB-2007, the patient was vaccinated PO with the third 2.0 mL dose of Rotateq. On 26-FEB-2007, the patient developed severe diarrhea and vomiting. Unspecified medical attention was sought. On 28-FEB-2007, the patient recovered from the severe diarrhea and vomiting while on therapy. Additional information has been requested. 29-OCT-2009 This is in follow-up to report (s) previously submitted on 4/13/2007. Information has been received from a physician concerning a 6-month-old female who on 26-OCT2-2006 was vaccinated PO with the first 2.0 mL dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). On 26-FEB-2007, the patient developed severe diarrhea and vomiting. Unspecified medical attention was sought. On 28-FEB-2007, the patient recovered from the severe diarrhea and vomiting while on therapy. No further information is available.
Age: 0.33
Sex: F
Vaccine: PNC, RV5
Symptoms: Abdominal X-ray, Haematemesis, Haemoglobin, Vomiting
Clinical narrative: Information has been received from a physician concerning a 4-month-old female with a history of ear infection who on 27-FEB-2007 was vaccinated with a dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of Prevnar. The physician reported that on 04-MAR-2007, the patient started to vomit which looked like it had some coffee granules and was bloody. Unspecified medical attention was sought. An abdominal x-ray and hemoglobin were performed (results not provided). At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning an 8 week old female who on 18 Dec 2006 was vaccinated with Rotateq (Lot# 654970/0777F). Concomitant vaccinations received on 18 Dec 2006 included Comvax, Prevnar, poliovirus vaccine and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 18 Dec 2006, the patient vomited several times after receiving Rotateq. The patient sought unspecified medical attention. Subsequently, the patient recovered from vomiting. The patient's guardian decided not to continued the series of Rotateq series in the future. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a physician concerning a "2-4" month old patient who was vaccinated with a 2 ml PO first dose of Rotateq. Subsequently the patient developed abdominal cramping after vaccination. Medical attention was sought. No labs were performed. Subsequently, the patient recovered. The patient will not received the rest of the series. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007.  Information has been received from a physician concerning a "2-4" month old patient who was vaccinated with a 2 ml PO first dose of ROTATEQ (lot # 655406/1114F).  Subsequently, on 10-DEC-2006 the patient developed abdominal cramping after vaccination.  The abdominal cramps lasted 1 day.  Subsequently, on 10-DEC-2006, the patient recovered.  Medical attention was sought.  No labs were performed.  The patient will not received the rest of the series.  There was no product quality complaint involved.  Additional information has been requested.