chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Blood electrolytes normal, Computerised tomogram head, Computerised tomogram normal, Conversion disorder, Electrocardiogram normal
Clinical narrative: Information has been received from a physician concerning a 13 or 14 year old male patient, who on approximately 09-MAR-2011 was vaccinated intramuscularly with his first 0.5 ml, dose of GARDASIL (lot # not reported). Secondary suspect therapy included VARIVAX (Merck). The physician reported that the patient fainted immediately after the vaccination and that the patient was not told to sit for 15 minutes following the vaccination. The patient was sent to Emergency Room, but was not admitted to the hospital, an X-Ray and a Computed Axial Tomography (CAT) scan were performed (results not provided). It was reported that therapy with GARDASIL was discontinued. Follow-up information has been received from a physician concerning a patient (59 inches, 88.6 pounds) with near syncope approximately 15FEB11 after receiving an unspecified "steroid shot," with no illness at time of vaccination or pre-existing allergies, birth defects, or medical conditions, who on 08MAR11 at 12:00 hours was vaccinated with a first dose of GARDASIL (lot # 667866/1437Z), on the left thigh. The physician reported that on 08MAR11 the patient experienced syncope. It was reported that the patient stood up and walked to front lobby, and passed out - about 3-5 minutes after receiving GARDASIL. Reportedly the patient hit his head on the floor and was hysterical afterward. A neurological examination and a head computed axial tomography (CT-Scan) were performed and both exams were within normal limits. The physician reported that patient vomited twice "and was fine after." At the time of the report, the patient's outcome was recovered. Follow-up information was received from a physician concerning a 14 year old male with a history of near syncope "almost passed out" after receiving a steroid shot (unspecified), who on 08MAR11 at 12:05 hours was vaccinated with a first dose of GARDASIL (lot # 667866/1437Z) intramuscularly. Secondary suspect therapy included a second dose of VARIVAX (Merck) (lot # 668585/1191Z). The physician reported that the patient put his shoes on and then walked to the front office. While his mother checked out he "felt funny" and then passed out. The patient fell and hit his chin on the counter and his head on the floor. The event occurred at least within 5 minutes of vaccination. The patient's neurological exam and CT scan were normal after the event. The physician reported that the patient required an emergency room/doctor visit. EKG, CT scan, CBC, electrolytes were all normal. The patient recovered. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Fall, Feeling abnormal, Full blood count normal, Head injury, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning a 13 or 14 year old male patient, who on approximately 09-MAR-2011 was vaccinated intramuscularly with his first 0.5 ml, dose of GARDASIL (lot # not reported). Secondary suspect therapy included VARIVAX (Merck). The physician reported that the patient fainted immediately after the vaccination and that the patient was not told to sit for 15 minutes following the vaccination. The patient was sent to Emergency Room, but was not admitted to the hospital, an X-Ray and a Computed Axial Tomography (CAT) scan were performed (results not provided). It was reported that therapy with GARDASIL was discontinued. Follow-up information has been received from a physician concerning a patient (59 inches, 88.6 pounds) with near syncope approximately 15FEB11 after receiving an unspecified "steroid shot," with no illness at time of vaccination or pre-existing allergies, birth defects, or medical conditions, who on 08MAR11 at 12:00 hours was vaccinated with a first dose of GARDASIL (lot # 667866/1437Z), on the left thigh. The physician reported that on 08MAR11 the patient experienced syncope. It was reported that the patient stood up and walked to front lobby, and passed out - about 3-5 minutes after receiving GARDASIL. Reportedly the patient hit his head on the floor and was hysterical afterward. A neurological examination and a head computed axial tomography (CT-Scan) were performed and both exams were within normal limits. The physician reported that patient vomited twice "and was fine after." At the time of the report, the patient's outcome was recovered. Follow-up information was received from a physician concerning a 14 year old male with a history of near syncope "almost passed out" after receiving a steroid shot (unspecified), who on 08MAR11 at 12:05 hours was vaccinated with a first dose of GARDASIL (lot # 667866/1437Z) intramuscularly. Secondary suspect therapy included a second dose of VARIVAX (Merck) (lot # 668585/1191Z). The physician reported that the patient put his shoes on and then walked to the front office. While his mother checked out he "felt funny" and then passed out. The patient fell and hit his chin on the counter and his head on the floor. The event occurred at least within 5 minutes of vaccination. The patient's neurological exam and CT scan were normal after the event. The physician reported that the patient required an emergency room/doctor visit. EKG, CT scan, CBC, electrolytes were all normal. The patient recovered. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Loss of consciousness, Neurological examination normal, Syncope, Vomiting, X-ray
Clinical narrative: Information has been received from a physician concerning a 13 or 14 year old male patient, who on approximately 09-MAR-2011 was vaccinated intramuscularly with his first 0.5 ml, dose of GARDASIL (lot # not reported). Secondary suspect therapy included VARIVAX (Merck). The physician reported that the patient fainted immediately after the vaccination and that the patient was not told to sit for 15 minutes following the vaccination. The patient was sent to Emergency Room, but was not admitted to the hospital, an X-Ray and a Computed Axial Tomography (CAT) scan were performed (results not provided). It was reported that therapy with GARDASIL was discontinued. Follow-up information has been received from a physician concerning a patient (59 inches, 88.6 pounds) with near syncope approximately 15FEB11 after receiving an unspecified "steroid shot," with no illness at time of vaccination or pre-existing allergies, birth defects, or medical conditions, who on 08MAR11 at 12:00 hours was vaccinated with a first dose of GARDASIL (lot # 667866/1437Z), on the left thigh. The physician reported that on 08MAR11 the patient experienced syncope. It was reported that the patient stood up and walked to front lobby, and passed out - about 3-5 minutes after receiving GARDASIL. Reportedly the patient hit his head on the floor and was hysterical afterward. A neurological examination and a head computed axial tomography (CT-Scan) were performed and both exams were within normal limits. The physician reported that patient vomited twice "and was fine after." At the time of the report, the patient's outcome was recovered. Follow-up information was received from a physician concerning a 14 year old male with a history of near syncope "almost passed out" after receiving a steroid shot (unspecified), who on 08MAR11 at 12:05 hours was vaccinated with a first dose of GARDASIL (lot # 667866/1437Z) intramuscularly. Secondary suspect therapy included a second dose of VARIVAX (Merck) (lot # 668585/1191Z). The physician reported that the patient put his shoes on and then walked to the front office. While his mother checked out he "felt funny" and then passed out. The patient fell and hit his chin on the counter and his head on the floor. The event occurred at least within 5 minutes of vaccination. The patient's neurological exam and CT scan were normal after the event. The physician reported that the patient required an emergency room/doctor visit. EKG, CT scan, CBC, electrolytes were all normal. The patient recovered. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Adverse event, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old male patient with drug allergy to cephalosporin antibiotics and penicillin and asthma who on 06-JUN-2011, was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly in the left thigh (lot number 667878/0180AA). Concomitant therapy included prednisone. On 06-JUN-2011, the patient experienced an allergic rash and approximately 2 hours later developed a rash on his stomach. The nurse reported that the mother of the patient called to the office. The patient received as treatment for the event BENADRYL. One hour after the patient had fully recovered. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dermatitis allergic, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old male patient with drug allergy to cephalosporin antibiotics and penicillin and asthma who on 06-JUN-2011, was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly in the left thigh (lot number 667878/0180AA). Concomitant therapy included prednisone. On 06-JUN-2011, the patient experienced an allergic rash and approximately 2 hours later developed a rash on his stomach. The nurse reported that the mother of the patient called to the office. The patient received as treatment for the event BENADRYL. One hour after the patient had fully recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Caesarean section, Drug exposure during pregnancy, Premature delivery
Clinical narrative: Information has been received from an administrator concerning a female neonate who was born to a 20 year old female with penicillin allergy and no pertinent medical history, who was on 09-AUG-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot# not reported). There was no concomitant medication. The infant's mother told the physician that she was not pregnant before she received a shot. The grandmother reported that the infant's mother became pregnant 4 or 5 days prior to getting the shot. The administrator reported from the mother's chart that she delivered the healthy female baby on 01-APR-2011 via C-section (cesarean section). The neonate weight 7 lb 0 oz. at 35 weeks gestation. There were no congenital anomalies noted in the mother's or /delivery record. The mother's experience has been captured in WAES # 1009USA00163. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Normal newborn, Premature delivery
Clinical narrative: Information has been received from an administrator concerning a female neonate who was born to a 20 year old female with penicillin allergy and no pertinent medical history, who was on 09-AUG-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot# not reported). There was no concomitant medication. The infant's mother told the physician that she was not pregnant before she received a shot. The grandmother reported that the infant's mother became pregnant 4 or 5 days prior to getting the shot. The administrator reported from the mother's chart that she delivered the healthy female baby on 01-APR-2011 via C-section (cesarean section). The neonate weight 7 lb 0 oz. at 35 weeks gestation. There were no congenital anomalies noted in the mother's or /delivery record. The mother's experience has been captured in WAES # 1009USA00163. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Burning sensation, Swelling face, Tenderness, Urticaria, Vulvovaginal discomfort
Clinical narrative: Information has been received from a physician concerning a 11 year old female with no pertinent medical history and no drug reactions or allergies who on 08-MAR-2011 was vaccinated IM with the first dose of 0.5 ml GARDASIL (lot # 667866/1437Z, expiration date February 2013). On 09-MAY-2011, around 09:00 AM, the patient was vaccinated IM with the second dose of 0.5 ml GARDASIL (lot # 668554/0306AA, expiration date January 2013). Concomitant therapy included a dose of MENACTRA received on 09-MAY-2011. On 09-MAY-2011 the patient experienced adverse reactions after receiving second dose of GARDASIL. On 09-MAY-2011, around 9:00 PM, the patient started complaining of vaginal irritation and burning and her nose felt burning as well. On the following morning of 10-MAY-2011, patient's lower half of the face including, cheeks and lips, was swollen, flushed and tender. The patient also noticed little rash around her vaginal area and developed hives inside of her both forearm. Hives appeared more on left arm than her right arm. The patient sought medical attention by office visit on 10-MAY-2011. The patient was treated with BENADRYL, CLARITIN, topical BENADRYL and AVEENO oatmeal bath. The status of the patient was unknown at the time of the report. Urine analysis was preformed, result unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Flushing, Genital rash, Nasal discomfort, Pain of skin, Swelling face
Clinical narrative: Information has been received from a physician concerning a 11 year old female with no pertinent medical history and no drug reactions or allergies who on 08-MAR-2011 was vaccinated IM with the first dose of 0.5 ml GARDASIL (lot # 667866/1437Z, expiration date February 2013). On 09-MAY-2011, around 09:00 AM, the patient was vaccinated IM with the second dose of 0.5 ml GARDASIL (lot # 668554/0306AA, expiration date January 2013). Concomitant therapy included a dose of MENACTRA received on 09-MAY-2011. On 09-MAY-2011 the patient experienced adverse reactions after receiving second dose of GARDASIL. On 09-MAY-2011, around 9:00 PM, the patient started complaining of vaginal irritation and burning and her nose felt burning as well. On the following morning of 10-MAY-2011, patient's lower half of the face including, cheeks and lips, was swollen, flushed and tender. The patient also noticed little rash around her vaginal area and developed hives inside of her both forearm. Hives appeared more on left arm than her right arm. The patient sought medical attention by office visit on 10-MAY-2011. The patient was treated with BENADRYL, CLARITIN, topical BENADRYL and AVEENO oatmeal bath. The status of the patient was unknown at the time of the report. Urine analysis was preformed, result unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Urticaria, Vulvovaginal burning sensation, Vulvovaginal discomfort
Clinical narrative: Information has been received from a physician concerning a 11 year old female with no pertinent medical history and no drug reactions or allergies who on 08-MAR-2011 was vaccinated IM with the first dose of 0.5 ml GARDASIL (lot # 667866/1437Z, expiration date February 2013). On 09-MAY-2011, around 09:00 AM, the patient was vaccinated IM with the second dose of 0.5 ml GARDASIL (lot # 668554/0306AA, expiration date January 2013). Concomitant therapy included a dose of MENACTRA received on 09-MAY-2011. On 09-MAY-2011 the patient experienced adverse reactions after receiving second dose of GARDASIL. On 09-MAY-2011, around 9:00 PM, the patient started complaining of vaginal irritation and burning and her nose felt burning as well. On the following morning of 10-MAY-2011, patient's lower half of the face including, cheeks and lips, was swollen, flushed and tender. The patient also noticed little rash around her vaginal area and developed hives inside of her both forearm. Hives appeared more on left arm than her right arm. The patient sought medical attention by office visit on 10-MAY-2011. The patient was treated with BENADRYL, CLARITIN, topical BENADRYL and AVEENO oatmeal bath. The status of the patient was unknown at the time of the report. Urine analysis was preformed, result unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Asthenia, Blindness, Blood chloride normal, Cyanosis, Electrocardiogram Q waves normal
Clinical narrative: Information has been received from a Registered Nurse and medical records concerning a 14 year old female (65.5 inches, 114 pounds) with no known allergies who on 24-JUN-2011 was vaccinated with a first dose of GARDASIL (lot #666948/0886Z) intramuscularly in the left arm. On the same date, the patient was also vaccinated with a second dose of VARIVAX (Merck) (lot #669277/1697Z) in the right arm. After being vaccinated, while still in the physician's office, the patient experienced weakness, fainted and complained of visual loss. Her pulse was thready, her blood pressure was 60/40, she was pale with blue lips. Oxygen was administered, juice was given to the patient as well as candy. After fifteen minutes, the patient was still weak. She was sent to the Emergency Room via ambulance. On arrival the patient's vital signs were temperature 96.9, pulse 55, respirations 14, blood pressure 113/96 and oxygen saturation level 96%. The patient was treated for chief complaint of near syncope with a 0.9% sodium chloride infusion. The patient's electrocardiogram was normal. The patient's chemistry values were within normal limits, with the exception of elevated chloride 109 mmol/L, and complete blood count was within normal limits. The patient had improved, blood pressure was 98/52 and pulse oximetry 99%. The patient was discharged home with diagnosis of vasovagal syncope. At the time of report, the patient had recovered. Upon internal review, visual loss was determined to be an other important medical event. All available medical records will be provided upon request. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Electrocardiogram normal, Full blood count normal, Laboratory test normal, Pallor, Presyncope
Clinical narrative: Information has been received from a Registered Nurse and medical records concerning a 14 year old female (65.5 inches, 114 pounds) with no known allergies who on 24-JUN-2011 was vaccinated with a first dose of GARDASIL (lot #666948/0886Z) intramuscularly in the left arm. On the same date, the patient was also vaccinated with a second dose of VARIVAX (Merck) (lot #669277/1697Z) in the right arm. After being vaccinated, while still in the physician's office, the patient experienced weakness, fainted and complained of visual loss. Her pulse was thready, her blood pressure was 60/40, she was pale with blue lips. Oxygen was administered, juice was given to the patient as well as candy. After fifteen minutes, the patient was still weak. She was sent to the Emergency Room via ambulance. On arrival the patient's vital signs were temperature 96.9, pulse 55, respirations 14, blood pressure 113/96 and oxygen saturation level 96%. The patient was treated for chief complaint of near syncope with a 0.9% sodium chloride infusion. The patient's electrocardiogram was normal. The patient's chemistry values were within normal limits, with the exception of elevated chloride 109 mmol/L, and complete blood count was within normal limits. The patient had improved, blood pressure was 98/52 and pulse oximetry 99%. The patient was discharged home with diagnosis of vasovagal syncope. At the time of report, the patient had recovered. Upon internal review, visual loss was determined to be an other important medical event. All available medical records will be provided upon request. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Pulse abnormal, Syncope
Clinical narrative: Information has been received from a Registered Nurse and medical records concerning a 14 year old female (65.5 inches, 114 pounds) with no known allergies who on 24-JUN-2011 was vaccinated with a first dose of GARDASIL (lot #666948/0886Z) intramuscularly in the left arm. On the same date, the patient was also vaccinated with a second dose of VARIVAX (Merck) (lot #669277/1697Z) in the right arm. After being vaccinated, while still in the physician's office, the patient experienced weakness, fainted and complained of visual loss. Her pulse was thready, her blood pressure was 60/40, she was pale with blue lips. Oxygen was administered, juice was given to the patient as well as candy. After fifteen minutes, the patient was still weak. She was sent to the Emergency Room via ambulance. On arrival the patient's vital signs were temperature 96.9, pulse 55, respirations 14, blood pressure 113/96 and oxygen saturation level 96%. The patient was treated for chief complaint of near syncope with a 0.9% sodium chloride infusion. The patient's electrocardiogram was normal. The patient's chemistry values were within normal limits, with the exception of elevated chloride 109 mmol/L, and complete blood count was within normal limits. The patient had improved, blood pressure was 98/52 and pulse oximetry 99%. The patient was discharged home with diagnosis of vasovagal syncope. At the time of report, the patient had recovered. Upon internal review, visual loss was determined to be an other important medical event. All available medical records will be provided upon request. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Death, Drug exposure via breast milk
Clinical narrative: Information has been received from a Doctor of science who authored an article published in journal. The author reported that a breast-feeding mother on unspecified date was vaccinated with GARDASIL and that shortly following the vaccination her baby died. The author stated that both mother and child were completely healthy prior to the vaccination. The mother's experience has been captured in WAES 1107USA04018. No further information is available.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Vaccines given Fri [04/29/11]; family went camping Sat & Sun [hiking, fishing]. Mon. started with low grade fever 100; 101 at 9pm then 103.4 ax at 11:30pm. Tues.: 5AM 103, 8AM 99 degrees - family checked for ticks & other bug bites or other problems - cont. to take fluids, now playful with low grade fever cont. IBP.
Age: 22.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Rec'd on 5/19/11 Tdap and Varicella vaccines. Presents today with c/o redness and swelling at site of Varicella. Tdap injection site not involved. Noted moderate swelling and 50mm x 50mm area of redness around injection site. Has been using ice packs, Ibuprofen, etc.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Crying, Rash macular
Clinical narrative: At approx 9:00 am RN administered PENTACEL to (L ) Vastus Lateralis IM, PREVNAR 13 IM (R) vastus lateralis & hep b IM (R) Vastus Lateralis approx 30 seconds after immunizations were administered infant broke out in erythematous symmetric red macule rash approx 1-2mm in size on anterior bilateral lower extremities below bilateral injection sites. Infant cried during shots & approx 1-2 min. after shots & then calmed down & no distress noted P-140, R-40, full & even, smiling at parents & responsive. Was seen by primary Dr 6/2/11 & stated that rash had faded. BENADRYL given & will f/u in 7 days & if further complications to go to ER.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Posture abnormal, Urinary incontinence
Clinical narrative: On 4/28/11 at approx 1;45 pm, patient came to clinic to receive her 2nd HPV GARDASIL shot. Administered shot to (L) deltoid with patient sitting in chair beside nurse's desk. Her mother was sitting next to patient. Approx. 3 minutes later, patient's head tilted back to wall and patient started to slump in chair. Arms bilaterally drew up to chin and patient voided her bladder. Nurse and mother on each side to stabilize her. We lowered patient gently to floor to elevate legs. Nurse called for assistance to nurse in hall to come help and check vital signs. Blood pressure on floor, 140/70, 3 minutes later escorted to exam table lying 120/70, then approx 15 minutes later prior to patient leaving clinic and sitting on exam table 118/70. After incident, patient's mom stated patient hadn't eaten and needed to urinate prior to coming into exam room.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: C/o pain (R) shoulder immediately post HBV #2, administered RD 6-17-11 with intermittent pain now. Site client indicated was mid deltoid muscle.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Body aches & sore throat with fevers since vaccine was given.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Hematochezia; hemoccult (pos) x 2.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Gaze palsy, Syncope
Clinical narrative: Pt given shot HPV into left arm. After about 1-2 min her eyes rolled back in her head and she appeared to have fainted. Came to within appx 30-45 sec. Was coherent afterwards but felt weak and dizzy. Pt was assisted to lie down. Bp checked 96/50. Given fluids/snack. Stayed in office for appx an hr afterwards. Ambulated out.
Age: 1.34
Sex: F
Vaccine: DT, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Chest X-ray normal, Dyspnoea, Febrile convulsion, Streptococcus test negative
Clinical narrative: Mother states that child collapsed and was having DIB. 911 was called. Pateint temp was 99.0 when ambulence arrive. Child vomited. Temp was 102.7 at hospital. Tylenol given. Chest xray, UA, and strep test was negative. Child was released. Dr. suspected febrile seizure r/t MMR. Referred to Pediatric Neurologist.
Age: 1.34
Sex: F
Vaccine: DT, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Syncope, Urine analysis normal, Vomiting
Clinical narrative: Mother states that child collapsed and was having DIB. 911 was called. Pateint temp was 99.0 when ambulence arrive. Child vomited. Temp was 102.7 at hospital. Tylenol given. Chest xray, UA, and strep test was negative. Child was released. Dr. suspected febrile seizure r/t MMR. Referred to Pediatric Neurologist.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash generalised, Varicella post vaccine
Clinical narrative: Patient states that in the evening after immunization she began feeling itchy and developed rash all over her body. She went to Hospital where she was admitted with Chickenpox. Patient discharged today (8/09/11). Patient brought note to Employee Health Services stating she had Chickenpox and will return to work on 8/15/11.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: 4 CM BY 4 CM ERYTHEMIC, RAISED RASH ON LEFT THIGH < 2 MM NEXT TO MMR INJECTION SITE. PT ASYMPTOMATIC, NO RX GIVEN.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Full blood count, Oedema peripheral, Pain, Pyrexia, Streptococcus test
Clinical narrative: PATIENT RETURNED TO CLINIC FOR FOLLOW-UP TB READING. MOM STATED PATIENT HAD FEVER AND VOMITING FOR 2 DAYS ALONG WITH SWELLING TO LEFT ARM. RX - ACETAMINOPHEN FOR FEVER AND PAIN
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: PATIENT RETURNED TO CLINIC FOR FOLLOW-UP TB READING. MOM STATED PATIENT HAD FEVER AND VOMITING FOR 2 DAYS ALONG WITH SWELLING TO LEFT ARM. RX - ACETAMINOPHEN FOR FEVER AND PAIN
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: CSF cell count increased, CSF test abnormal, Meningitis aseptic, Mental status changes, Pyrexia
Clinical narrative: Altered mental status, vomiting, fever
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Altered mental status, vomiting, fever
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Epistaxis
Clinical narrative: Pt received Kinrix, MMR II, and varicella vaccination. Following vaccination pt nose began to bleed.
Age: 0.82
Sex: M
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: generalized rash
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site necrosis
Clinical narrative: Pt arrived at 15 months on 8/9/11 and showed me a spot on Rt outer leg that appeared to be fat necrosis from a previous vaccine first noticed by mom after 12 month visit. Hep A was given at that point at that visit on 5/9/11. No treatment - will monitor.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised
Clinical narrative: Rash all over. Started 2 hours after injection, controlled with BENADRYL. Getting better.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abnormal behaviour, Culture negative, Irritability, Lethargy, Nausea
Clinical narrative: Fevers 102-103.8 beginning right after vaccines given. Also c/o ST, SA, nausea. Continues to have intermittent fevers, ST, lethargy and irritability for 2 wks post vacc. Mom feels behavior is diff't after vaccines.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Fevers 102-103.8 beginning right after vaccines given. Also c/o ST, SA, nausea. Continues to have intermittent fevers, ST, lethargy and irritability for 2 wks post vacc. Mom feels behavior is diff't after vaccines.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm - injection site warm, swollen - red next day - treated for cellulitis 8-8-11.
Age: 8.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site fibrosis, Injection site pain, Pyrexia
Clinical narrative: Patient with tenderness to injection site with erythema. Ice packs & NSAIDS for fever recommended.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pain in extremity
Clinical narrative: HPV vaccine adm at last MCV4 & BOOSTRIX given on (L) arm, first, HPV given on (R) arm. C/O pain after given mom was told to wait, said she would order shot records for siblings up front.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Computerised tomogram abnormal, Intussusception, Vomiting
Clinical narrative: 8-9-11 vomiting, CT confirmed large colonic intussusception.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Nausea, Oedema peripheral, Pain in extremity
Clinical narrative: Rt arm swollen, painful of pneumonia shot given on 6/30/11. Seen MD to for follow up 7/1/11. Pt had chills, nausea. Sx worse the next day 7/2/11 went to ER given KEFLEX.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Area of erythema, induration and swelling, (R) upper arm, around site of DTaP injection. Noted 8 cm x 9 cm on 8/3/11, pt seen on 8/4/11, redness & swelling slightly improved.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: On 8-5-11 at 3:08 p.m. mom reported pt had developed a 3 inch long red, raised area on the (R) leg that was warm to touch. She also had a fever of 102. Was seen on 8-6-11 at 4:30 pm and the area of redness was 9cm x 4cm. Was started on Amoxicillin 250mg TID x 7 days.
Age: 36.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Pt reports entire (R) upper arm red & swollen < 24 hrs post vaccine. Reports body aches as well. At time of evaluation 7 inch x 17 inch area of redness on upper arm.
Age: 0.6
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: Rec'd 3rd dose of rotavirus vaccine on 7/6/11. Developed intussusception on 7/18/11. Reduced via air enema.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Patient developed shingle type rash on arm.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Chills, Feeling of body temperature change, Hyperaesthesia
Clinical narrative: Fever & runny nose & eyes - thought was flu. Hot to cold shaking chills. Fourth day large blister rash chest and neck oozing & itchy & sensitive. Today still rash & burning warm.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Lacrimation increased, Pruritus, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Fever & runny nose & eyes - thought was flu. Hot to cold shaking chills. Fourth day large blister rash chest and neck oozing & itchy & sensitive. Today still rash & burning warm.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm, Tremor, Wound secretion
Clinical narrative: Fever & runny nose & eyes - thought was flu. Hot to cold shaking chills. Fourth day large blister rash chest and neck oozing & itchy & sensitive. Today still rash & burning warm.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Right arm red, swollen 3 x 4 in. warm to touch. Reminded father to apply cold pack every 2 hrs. for 10-15 min for 24hrs. then warm pack after 24hr. and call if not better after 24 hrs.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling and warm to touch in deltoid after night of vaccine - pt was given oral BENADRYL 25mg po. in office as well as DECADRON 12mg po.
Age: 4.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site pain, Injection site pustule, Injection site swelling
Clinical narrative: (L) arm slight swollen - pain on site of vaccine given DTAP # 4 - "pus" bubble "popped" burst. Treatment: TAC 0.1 oint & Bacitracin ointment given.
Age: 4.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse event/sx. Tdap inadvertently administered instead of DTAP.
Age: 32.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Pain
Clinical narrative: aching all over body, erythema  extremities, right shoulder
Age: 29.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Injection site rash, Rash
Clinical narrative: Pt. complained of a rash which appeared on both arms from the elbows to the shoulder. Denies itching or pain. Rash duration of 2 hours and occurred 1 hour following immunization. Pt did not see doctor no tx was given.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Right shoulder pain and rash
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Oedema peripheral
Clinical narrative: Pronounced edema at and around injection site. Edema extended down arm nearly to elbow. No fever, nausea, vomiting or systemic symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash macular
Clinical narrative: Right thigh swollen from injection site down to knee with red splotches. Nontender with full range of motion. Upon questioning at last vaccinations at 2 years of age same thing happened in arm and was hospitalized overnight.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Lacrimation increased, Pallor
Clinical narrative: Administered Tdap, Meningococcal, and HPV. Pt became teary after HPV injection and within 5 minutes stated her head hurt, became pale.  Sat her down, cool rag to forehead, took vitals (106/60, P92, R12, T97.6)Had pt stay in area for 20 minutes.  States she is fine before leaving the clinic.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash papular
Clinical narrative: Diffuse rash noted. Red, best characterized as papular and small halos surrounding.
Age: 27.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: no adverse outcomes-vaccine administered during pregnancy
Age: 25.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Drug exposure during pregnancy
Clinical narrative: vaccine administered during early pregnancy
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Choking sensation, Neck pain, Rash generalised
Clinical narrative: NECK PAIN (day of vaccination), CHEST TIGHTNESS, CHOKING SENSATIONS, and GENERAL BODY RASH (all within 24-hours); all symptoms were still present last visit (08/08/2011).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Headache, Malaise, Pyrexia, Vomiting
Clinical narrative: Suddenly not feeling well, severe headache lasting 24 hours, 102.5 fever that lasted all night and into the next day, vomiting that night
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Chills, Gaze palsy, Hypertonia, Muscle spasms, Nausea
Clinical narrative: Pt started shaking and eyes rolled back momentarily after the Hepatitis A vaccine was given on the right upper arm. Pt received the Menveo vaccine in the left upper arm without problems. Pt assisted to supine position. Vital signs taken and BP 100/80 HR 88, T 98. PT is alert, oriented x 4, cooperative. Pt also complained of mild nausea. After several minutes, pt denies nausea but states "I feel like I'm shaking everywhere. VS at 4 pm BP 124/84, HR 76, SPO2 99. 407 pm, Pt states that the shivering sensation is still present, mild muscle spasms noted on bilateral legs. Product insert for Havrix pulled out and discussed with pt's Mother, discussed that 1-10% of injections will have a CNS adverse reactions including hypertonic episode. VS at 417 pm SPO2 at 99% room air, HR 74, BP 122/86. Pt remains in supine position as of this time. at 425 pm Hypertonic episode persists, pt assisted to sitting position elicited more spasms of the lower extremities. VS at 420 pm BP 120/80 HR 72, SPO2 at room air 99% T 98 F. Pt is alert, oriented x 4, responds appropriately to command. Pt transported to hospital.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Tremor
Clinical narrative: Pt started shaking and eyes rolled back momentarily after the Hepatitis A vaccine was given on the right upper arm. Pt received the Menveo vaccine in the left upper arm without problems. Pt assisted to supine position. Vital signs taken and BP 100/80 HR 88, T 98. PT is alert, oriented x 4, cooperative. Pt also complained of mild nausea. After several minutes, pt denies nausea but states "I feel like I'm shaking everywhere. VS at 4 pm BP 124/84, HR 76, SPO2 99. 407 pm, Pt states that the shivering sensation is still present, mild muscle spasms noted on bilateral legs. Product insert for Havrix pulled out and discussed with pt's Mother, discussed that 1-10% of injections will have a CNS adverse reactions including hypertonic episode. VS at 417 pm SPO2 at 99% room air, HR 74, BP 122/86. Pt remains in supine position as of this time. at 425 pm Hypertonic episode persists, pt assisted to sitting position elicited more spasms of the lower extremities. VS at 420 pm BP 120/80 HR 72, SPO2 at room air 99% T 98 F. Pt is alert, oriented x 4, responds appropriately to command. Pt transported to hospital.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature, Pain, Rash generalised, Rash macular
Clinical narrative: Body aches, temp, rash all over body. Macular rash.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dyspnoea, Throat irritation, Urticaria
Clinical narrative: Itchy throat, SOB, whelps.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Oedema peripheral
Clinical narrative: (L) upper arm red & swollen.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Fine raised rash on face, trunk. Advised give BENADRYL for itch call if sx worse.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Received shot Fri, over weekend area became red, hardened approx 3" diameter. Sore. Taking MOTRIN ,warm compress to area. States area smaller this am, 8-8-11.
Age: 8.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Cough, Decreased appetite, Fatigue, Malaise
Clinical narrative: Patient was given MMR vaccine around 10AM 7/25. Mom reports that on the night of 7/29 she became ill with sore throat, malaise, nasal congestion. On 8/3 symptoms continue with a cough, sore throat & fatigue. On 8/4 extreme fatigue so that she had to be carried to her bed. Temp 102.2 orally. Eyes sensitive to light, pallor. No appetite. On 8/5 she began to improve & has recovered for the most.
Age: 8.0
Sex: F
Vaccine: MMR
Symptoms: Nasal congestion, Oropharyngeal pain, Pallor, Photophobia
Clinical narrative: Patient was given MMR vaccine around 10AM 7/25. Mom reports that on the night of 7/29 she became ill with sore throat, malaise, nasal congestion. On 8/3 symptoms continue with a cough, sore throat & fatigue. On 8/4 extreme fatigue so that she had to be carried to her bed. Temp 102.2 orally. Eyes sensitive to light, pallor. No appetite. On 8/5 she began to improve & has recovered for the most.
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Diarrhoea, Erythema, Pain, Skin warm
Clinical narrative: Mild weakness & diarrhea. Redness, tenderness, pain, swelling, warmth noted at cranial nerve V1/V2 distribution.
Sex: M
Vaccine: UNK
Symptoms: Swelling, Tenderness
Clinical narrative: Mild weakness & diarrhea. Redness, tenderness, pain, swelling, warmth noted at cranial nerve V1/V2 distribution.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypotension, Syncope
Clinical narrative: Fainted. Placed supine, initially hypotensive 110/62 & recovered quickly (120/70).
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope, Vomiting
Clinical narrative: Complained of feeling lightheaded and then fainted. Vomited mucus x 1. Placed supine & recovered quickly.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Antibody test negative, Arthralgia, Bacterial test negative, Blood culture negative, Borrelia test negative
Clinical narrative: Contacted clinic day after vaccine given with report of local reaction to (L) arm and then continued to develop progressive symptoms of malaise, fatigue, arthralgias, myalgias.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: C-reactive protein increased, Fatigue, Fibrin D dimer normal, Full blood count normal, Local reaction
Clinical narrative: Contacted clinic day after vaccine given with report of local reaction to (L) arm and then continued to develop progressive symptoms of malaise, fatigue, arthralgias, myalgias.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Myalgia, Red blood cell sedimentation rate increased
Clinical narrative: Contacted clinic day after vaccine given with report of local reaction to (L) arm and then continued to develop progressive symptoms of malaise, fatigue, arthralgias, myalgias.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Fall, Headache, Syncope
Clinical narrative: After injection, pt waited about 3-4 minutes and stood to leave - felt lightheaded - and fell to floor. LOC x < 1 minute. Following syncope noted headache x < 10 minutes (mild). Monitored x 30 more min - accompanied home by sibling.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Petit mal epilepsy
Clinical narrative: Petite seizure. No treatment needed, recovery full. No postictal period.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: Pt got severe dizziness after Tdap (BOOSTRIX) was administered. Called 9-1-1. Pt was evaluated by EMS and was then fine and walked out of the store by himself.
Age: 0.37
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site atrophy
Clinical narrative: Atrophy in right thigh.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Headache, Syncope
Clinical narrative: Pt. fainted after receiving 2nd vaccine in office, MA took her BP 112/69 and pulse was 55; Pt c/o HA and was given adult dose of MOTRIN.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Pt feels tingling in nerves.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Rash, Urticaria
Clinical narrative: Hives, rash all over face, neck, behind ears.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site swelling, Pain
Clinical narrative: Swelling at injection site. Pain & discomfort night of injection given; patient went to ER nearby hosp for treatment. Sent home with pain med and ice pack(cold compress). Diagnosis of hematosis.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: Became lightheaded & fainted after leaving office. Returned to office by father: BP 92/50. Received Gatorade & crackers & recovered.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Fainted. Placed supine w quick recovery.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever 100 degrees plus x 24 hr 7/27 - 7/28, headache since 7/26, nausea since 7/27, body aches since 7/27.
Sex: F
Vaccine: VARZOS
Symptoms: Muscle twitching
Clinical narrative: Information has been received from a doctor of pharmacy student concerning a female patient, who on 13-MAY-2011 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (Lot # 669867/0361AA EXP 09-JUN-2012) SQ. On an unspecified date the patient experienced twitching in her jaw. There were no Lab diagnosis/studies performed. The patient did not seek medical attention. It was reported that the patient had not received treatment for the adverse event. At the time of the report, the patient had not recovered. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac function test normal, Clonus, Electroencephalogram normal, Fall, Impaired driving ability
Clinical narrative: Information has been received from a registered pharmacist concerning her 17 year old daughter with depression and anxiety who 07-NOV-2006, 28-FEB-2007 and 19-JUN-2007 was vaccinate with first, second and third dose of GARDASIL (lot # not reported respectively). The patient experienced four syncopal episodes with clonic movements on 25-JUN-2007 while she was playing soccer (only time the patient was hospitalized, in October 2008, on 31-DEC-2009 while playing hockey and in February 2011 in another country when she was studying, each episode lasted "a few minutes" according to the registered pharmacist. Patient fell and injured during the 31-DEC-2009 episode. Cardiac tests and EEG were performed, however nothing had revealed a possible cause. At the time of reporting the patient had not recovered from fell and injury, the patient was recently referred to an epilepsy specialist. Also the patient just recently told not to drive. The events not life threatening according to the registered of pharmacist. The health care professional contacted during the telephone follow-up could not supply the following information: lot numbers. Follow information has been received from a registered of pharmacist who reported that her daughter had no previous syncopal/ tonic events (prior to June 2007). She had approximately 1 event per year. Symptoms included fainting and tonic clonic events. After first and second dose of GARDASIL the patient did not experience syncopal or tonic clonic events. This is an amended report. The year for the second dose in therapy screen was changed to 28-FEB-2007. Additional information has been requested.