chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: This spontaneous report was received from healthcare worker, for GARDASIL, a Pregnancy Registry product, regarding a 32 year old female patient. The patient has penicillin allergy. On 28-Mar-2013, the patient was vaccinated with a dose of 0.5ml GARDASIL, (lot number reported as H020910, expiry date 18-JUN-2015 and route was intramuscular) instead of Tdap due to human error. Other suspect therapy was SINGULAIR. Concomitant therapies included SYNTHROID. The patient was found to be pregnant. No known adverse effects reported. The patient did not have any laboratory tests performed. The patient did not seek medical attention. Follow up information has been received from the registered medical assistant refers to a 32 years old female patient with hypothyroidism, asthma, penicillin allergy and no drug or alcohol use. It was reported that on 28-MAR-2013, the patient received GARDASIL in the deltoid. It was reported that previously, the patient had delivered a male baby (weight 8 lb 9.5 oz). The weeks from LMP were 41 weeks and outcome was good. The patient became pregnant with LMP of 15-SEP-2012 and EDD of 22-JUN-2013. Initial exposure to GARDASIL was at 2 week(s). On 25-JUN-13 at 40 weeks gestation, the patient delivered a female infant (weighing 8lb 6.6 oz, length 21.5 inches) via vaginal delivery. The pregnancy outcome was live birth. The infant's APGAR scores were 9 at one minute and 9 at five minutes. The following labs were performed: on 08-NOV-2012 (7 weeks) pregnancy test (urine serum) positive, ABO/RH A+, toxoplasmosis) non-immune; MSAFP on 25-JAN-2013 (18 weeks) (Maternal Serum Alpha Fetoprotein) negative; on 25-JAN-2013 (18 weeks) ultrasound normal anatomy scan; on 28-MAR-2013 (27 weeks)glucose 121; on 23-MAY-2013 (35 weeks) B-strep negative. On 25-JUN-2013, the patient experienced episiotomy during the delivery (fast labor). There were no congenital anomalies in the infant. There was no neonatal problem. And the infant was normal. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alpha 1 foetoprotein normal, Amylase normal, Blood glucose normal, Delivery, Episiotomy
Clinical narrative: This spontaneous report was received from healthcare worker, for GARDASIL, a Pregnancy Registry product, regarding a 32 year old female patient. The patient has penicillin allergy. On 28-Mar-2013, the patient was vaccinated with a dose of 0.5ml GARDASIL, (lot number reported as H020910, expiry date 18-JUN-2015 and route was intramuscular) instead of Tdap due to human error. Other suspect therapy was SINGULAIR. Concomitant therapies included SYNTHROID. The patient was found to be pregnant. No known adverse effects reported. The patient did not have any laboratory tests performed. The patient did not seek medical attention. Follow up information has been received from the registered medical assistant refers to a 32 years old female patient with hypothyroidism, asthma, penicillin allergy and no drug or alcohol use. It was reported that on 28-MAR-2013, the patient received GARDASIL in the deltoid. It was reported that previously, the patient had delivered a male baby (weight 8 lb 9.5 oz). The weeks from LMP were 41 weeks and outcome was good. The patient became pregnant with LMP of 15-SEP-2012 and EDD of 22-JUN-2013. Initial exposure to GARDASIL was at 2 week(s). On 25-JUN-13 at 40 weeks gestation, the patient delivered a female infant (weighing 8lb 6.6 oz, length 21.5 inches) via vaginal delivery. The pregnancy outcome was live birth. The infant's APGAR scores were 9 at one minute and 9 at five minutes. The following labs were performed: on 08-NOV-2012 (7 weeks) pregnancy test (urine serum) positive, ABO/RH A+, toxoplasmosis) non-immune; MSAFP on 25-JAN-2013 (18 weeks) (Maternal Serum Alpha Fetoprotein) negative; on 25-JAN-2013 (18 weeks) ultrasound normal anatomy scan; on 28-MAR-2013 (27 weeks)glucose 121; on 23-MAY-2013 (35 weeks) B-strep negative. On 25-JUN-2013, the patient experienced episiotomy during the delivery (fast labor). There were no congenital anomalies in the infant. There was no neonatal problem. And the infant was normal. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Live birth, Precipitate labour, Pregnancy test urine positive, Streptococcus test negative
Clinical narrative: This spontaneous report was received from healthcare worker, for GARDASIL, a Pregnancy Registry product, regarding a 32 year old female patient. The patient has penicillin allergy. On 28-Mar-2013, the patient was vaccinated with a dose of 0.5ml GARDASIL, (lot number reported as H020910, expiry date 18-JUN-2015 and route was intramuscular) instead of Tdap due to human error. Other suspect therapy was SINGULAIR. Concomitant therapies included SYNTHROID. The patient was found to be pregnant. No known adverse effects reported. The patient did not have any laboratory tests performed. The patient did not seek medical attention. Follow up information has been received from the registered medical assistant refers to a 32 years old female patient with hypothyroidism, asthma, penicillin allergy and no drug or alcohol use. It was reported that on 28-MAR-2013, the patient received GARDASIL in the deltoid. It was reported that previously, the patient had delivered a male baby (weight 8 lb 9.5 oz). The weeks from LMP were 41 weeks and outcome was good. The patient became pregnant with LMP of 15-SEP-2012 and EDD of 22-JUN-2013. Initial exposure to GARDASIL was at 2 week(s). On 25-JUN-13 at 40 weeks gestation, the patient delivered a female infant (weighing 8lb 6.6 oz, length 21.5 inches) via vaginal delivery. The pregnancy outcome was live birth. The infant's APGAR scores were 9 at one minute and 9 at five minutes. The following labs were performed: on 08-NOV-2012 (7 weeks) pregnancy test (urine serum) positive, ABO/RH A+, toxoplasmosis) non-immune; MSAFP on 25-JAN-2013 (18 weeks) (Maternal Serum Alpha Fetoprotein) negative; on 25-JAN-2013 (18 weeks) ultrasound normal anatomy scan; on 28-MAR-2013 (27 weeks)glucose 121; on 23-MAY-2013 (35 weeks) B-strep negative. On 25-JUN-2013, the patient experienced episiotomy during the delivery (fast labor). There were no congenital anomalies in the infant. There was no neonatal problem. And the infant was normal. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ultrasound scan normal, Wrong drug administered
Clinical narrative: This spontaneous report was received from healthcare worker, for GARDASIL, a Pregnancy Registry product, regarding a 32 year old female patient. The patient has penicillin allergy. On 28-Mar-2013, the patient was vaccinated with a dose of 0.5ml GARDASIL, (lot number reported as H020910, expiry date 18-JUN-2015 and route was intramuscular) instead of Tdap due to human error. Other suspect therapy was SINGULAIR. Concomitant therapies included SYNTHROID. The patient was found to be pregnant. No known adverse effects reported. The patient did not have any laboratory tests performed. The patient did not seek medical attention. Follow up information has been received from the registered medical assistant refers to a 32 years old female patient with hypothyroidism, asthma, penicillin allergy and no drug or alcohol use. It was reported that on 28-MAR-2013, the patient received GARDASIL in the deltoid. It was reported that previously, the patient had delivered a male baby (weight 8 lb 9.5 oz). The weeks from LMP were 41 weeks and outcome was good. The patient became pregnant with LMP of 15-SEP-2012 and EDD of 22-JUN-2013. Initial exposure to GARDASIL was at 2 week(s). On 25-JUN-13 at 40 weeks gestation, the patient delivered a female infant (weighing 8lb 6.6 oz, length 21.5 inches) via vaginal delivery. The pregnancy outcome was live birth. The infant's APGAR scores were 9 at one minute and 9 at five minutes. The following labs were performed: on 08-NOV-2012 (7 weeks) pregnancy test (urine serum) positive, ABO/RH A+, toxoplasmosis) non-immune; MSAFP on 25-JAN-2013 (18 weeks) (Maternal Serum Alpha Fetoprotein) negative; on 25-JAN-2013 (18 weeks) ultrasound normal anatomy scan; on 28-MAR-2013 (27 weeks)glucose 121; on 23-MAY-2013 (35 weeks) B-strep negative. On 25-JUN-2013, the patient experienced episiotomy during the delivery (fast labor). There were no congenital anomalies in the infant. There was no neonatal problem. And the infant was normal. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Depressed level of consciousness, Dizziness
Clinical narrative: Case number PHHY2013US056725, is initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 489030) website on 05 Jun 2013 with a follow-up received from the Quality Assurance Department (reference number: 234101) on 04 Jul 2013. This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. He had no known allergy. He was vaccinated with MENVEO (batch number: M12013) intramuscularly in the right arm, GARDASIL (other manufacturer, batch number: H017698) intramuscularly in the right arm and ADACEL (other manufacturer, batch number: U4421AA) intramuscularly in the left arm on 10 Apr 2013. He was seated in a chair for observation after vaccine administration. Two minutes later, he experienced dizziness. He then had a change in "LOC" (level of consciousness). He was taken to the emergency room. It was also reported that the paramedics were called. The event outcome was reported as completely recovered. The seriousness and causality were not reported. Based on the batch review report received from the QA department on 04 Jul 2013, it was concluded that the concerned MENVEO (batch number: M12013) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No additional information was available. Follow-up received from the Quality Assurance Department on 04 Jul 2013: Updated batch review report.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Altered state of consciousness, Dizziness
Clinical narrative: Case number PHHY2013US056725, is initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 489030) website on 05 Jun 2013 with a follow-up received from the Quality Assurance Department (reference number: 234101) on 04 Jul 2013. This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. He had no known allergy. He was vaccinated with MENVEO (batch number: M12013) intramuscularly in the right arm, GARDASIL (other manufacturer, batch number: H017698) intramuscularly in the right arm and ADACEL (other manufacturer, batch number: U4421AA) intramuscularly in the left arm on 10 Apr 2013. He was seated in a chair for observation after vaccine administration. Two minutes later, he experienced dizziness. He then had a change in "LOC" (level of consciousness). He was taken to the emergency room. It was also reported that the paramedics were called. The event outcome was reported as completely recovered. The seriousness and causality were not reported. Based on the batch review report received from the QA department on 04 Jul 2013, it was concluded that the concerned MENVEO (batch number: M12013) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No additional information was available. Follow-up received from the Quality Assurance Department on 04 Jul 2013: Updated batch review report.
Age: 43.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 43 year old male patient with bipolar disorder and allergy to codeine, hydrocodone, IV contrast dye, sea food and bee stings. On 08-JUL-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H022172, expiration date August 2014), (dose unknown), via intramuscular in the right deltoid. Concomitant therapies included TYLENOL, benztropine, enalapril, hydrochlorothiazide, lorazepam, perphenazine, trazodone and BENADRYL. The patient developed cellulitis at the injection site in the right deltoid. The reporter stated that the patient was already hospitalized for an unspecified reason at the time he received PNEUMOVAX23. It was reported that the patient went to the emergency department for evaluation and she was not sure what happened with the patient after that evaluation and if the adverse experience contributed to patient's hospital stay. The reporter requested a lot check for the specified lot number. The outcome of the patient developed cellulitis at the injection site in the right deltoid was unknown. The event was considered serious due to hospitalization criteria. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a registered nurse and refers to a  64 year old male patient with diabetes, hyperlipidemia and hypertension and with no known drug allergies. On 17-JUN-2013 the patient was vaccinated once with the first dose of ZOSTAVAX 0.65 ml, subcutaneously (lot # J001003, expiry date 24-APR-2014) for Shingles prevention. Concomitant medication included unspecified medications for cholesterol, blood pressure and for blood sugar. It was reported that the patient contacted office and had visit with unspecified physician in the practice on 29-JUN-2013 for pain in back that patient developed on 27-JUN-2013. On 05-JUL-2013 the patient was still experiencing pain and was seen in the office. At the time of visit on 05-JUL-2013 the patient had lesions, tingles and pinkness in specified areas of the body: back, abdomen and lower chest. it was reported that the patient was described as "9 of 10" and the doctor determined post herpetic neuralgia. It was reported that the patient was taking ibuprofen every 2 hours, complained of pain the complained of itching (also reported as denied itching at the office visit of 05-JUL-2013) so patient was prescribed topical cream - ZOVIRAX at time of office visit on 05-JUL-2013. No lab diagnostics studies were performed. On 07-JUL-2013 the patient called the office back for more ZOVIRAX cream which doctor considered "patient unresponsive" to ZOVIRAX cream and prescribed pain medications: hydrocodone, acetaminophen and gabapentin. The nurse reported that the patient was due to come back for office visit on 12-JUL-2013. The outcome of post herpetic pain was reported as not recovered and the outcome of the rest of the events was not reported. The patient sought medical attention by office visit. The relatedness between ZOSTAVAX and the events was not assessed by the reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Drug ineffective, Erythema, Paraesthesia, Post herpetic neuralgia
Clinical narrative: This spontaneous report has been received from a registered nurse and refers to a  64 year old male patient with diabetes, hyperlipidemia and hypertension and with no known drug allergies. On 17-JUN-2013 the patient was vaccinated once with the first dose of ZOSTAVAX 0.65 ml, subcutaneously (lot # J001003, expiry date 24-APR-2014) for Shingles prevention. Concomitant medication included unspecified medications for cholesterol, blood pressure and for blood sugar. It was reported that the patient contacted office and had visit with unspecified physician in the practice on 29-JUN-2013 for pain in back that patient developed on 27-JUN-2013. On 05-JUL-2013 the patient was still experiencing pain and was seen in the office. At the time of visit on 05-JUL-2013 the patient had lesions, tingles and pinkness in specified areas of the body: back, abdomen and lower chest. it was reported that the patient was described as "9 of 10" and the doctor determined post herpetic neuralgia. It was reported that the patient was taking ibuprofen every 2 hours, complained of pain the complained of itching (also reported as denied itching at the office visit of 05-JUL-2013) so patient was prescribed topical cream - ZOVIRAX at time of office visit on 05-JUL-2013. No lab diagnostics studies were performed. On 07-JUL-2013 the patient called the office back for more ZOVIRAX cream which doctor considered "patient unresponsive" to ZOVIRAX cream and prescribed pain medications: hydrocodone, acetaminophen and gabapentin. The nurse reported that the patient was due to come back for office visit on 12-JUL-2013. The outcome of post herpetic pain was reported as not recovered and the outcome of the rest of the events was not reported. The patient sought medical attention by office visit. The relatedness between ZOSTAVAX and the events was not assessed by the reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Skin lesion
Clinical narrative: This spontaneous report has been received from a registered nurse and refers to a  64 year old male patient with diabetes, hyperlipidemia and hypertension and with no known drug allergies. On 17-JUN-2013 the patient was vaccinated once with the first dose of ZOSTAVAX 0.65 ml, subcutaneously (lot # J001003, expiry date 24-APR-2014) for Shingles prevention. Concomitant medication included unspecified medications for cholesterol, blood pressure and for blood sugar. It was reported that the patient contacted office and had visit with unspecified physician in the practice on 29-JUN-2013 for pain in back that patient developed on 27-JUN-2013. On 05-JUL-2013 the patient was still experiencing pain and was seen in the office. At the time of visit on 05-JUL-2013 the patient had lesions, tingles and pinkness in specified areas of the body: back, abdomen and lower chest. it was reported that the patient was described as "9 of 10" and the doctor determined post herpetic neuralgia. It was reported that the patient was taking ibuprofen every 2 hours, complained of pain the complained of itching (also reported as denied itching at the office visit of 05-JUL-2013) so patient was prescribed topical cream - ZOVIRAX at time of office visit on 05-JUL-2013. No lab diagnostics studies were performed. On 07-JUL-2013 the patient called the office back for more ZOVIRAX cream which doctor considered "patient unresponsive" to ZOVIRAX cream and prescribed pain medications: hydrocodone, acetaminophen and gabapentin. The nurse reported that the patient was due to come back for office visit on 12-JUL-2013. The outcome of post herpetic pain was reported as not recovered and the outcome of the rest of the events was not reported. The patient sought medical attention by office visit. The relatedness between ZOSTAVAX and the events was not assessed by the reporter. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Asthenia, Fall, Immediate post-injection reaction
Clinical narrative: This case was reported by a healthcare professional (office manager) and described the occurrence of deep breathing in a 31-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). The subject's medical history included testicular cancer. On 11 July 2013 at 14:30 the subject received 1st dose of HAVRIX (1 ml, intramuscular, left deltoid). On 11 July 2013, within seconds of vaccination with HAVRIX, the subject experienced deep breathing, flushing, not feeling well (described as "did not feel right"), nervousness, palpitation, itching neck and hand tingling. The reporter stated that "within seconds of receiving HAVRIX vaccination" the subject "started to breath deeply, complained of flushing, did not feel right, started to get nervous, palpitations." The reporter also stated that the subject's "skin around neck felt itchy and hands tingly." The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with BENADRYL and laid down on the exam table. At the time of reporting the outcome of the events were unspecified. The office manager reported another case with HAVRIX. See case A1033622A for details on the other case.
Age: 31.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Feeling abnormal, Flushing, Hyperventilation, Malaise, Nervousness
Clinical narrative: This case was reported by a healthcare professional (office manager) and described the occurrence of deep breathing in a 31-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). The subject's medical history included testicular cancer. On 11 July 2013 at 14:30 the subject received 1st dose of HAVRIX (1 ml, intramuscular, left deltoid). On 11 July 2013, within seconds of vaccination with HAVRIX, the subject experienced deep breathing, flushing, not feeling well (described as "did not feel right"), nervousness, palpitation, itching neck and hand tingling. The reporter stated that "within seconds of receiving HAVRIX vaccination" the subject "started to breath deeply, complained of flushing, did not feel right, started to get nervous, palpitations." The reporter also stated that the subject's "skin around neck felt itchy and hands tingly." The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with BENADRYL and laid down on the exam table. At the time of reporting the outcome of the events were unspecified. The office manager reported another case with HAVRIX. See case A1033622A for details on the other case.
Age: 31.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Palpitations, Paraesthesia, Pruritus
Clinical narrative: This case was reported by a healthcare professional (office manager) and described the occurrence of deep breathing in a 31-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). The subject's medical history included testicular cancer. On 11 July 2013 at 14:30 the subject received 1st dose of HAVRIX (1 ml, intramuscular, left deltoid). On 11 July 2013, within seconds of vaccination with HAVRIX, the subject experienced deep breathing, flushing, not feeling well (described as "did not feel right"), nervousness, palpitation, itching neck and hand tingling. The reporter stated that "within seconds of receiving HAVRIX vaccination" the subject "started to breath deeply, complained of flushing, did not feel right, started to get nervous, palpitations." The reporter also stated that the subject's "skin around neck felt itchy and hands tingly." The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with BENADRYL and laid down on the exam table. At the time of reporting the outcome of the events were unspecified. The office manager reported another case with HAVRIX. See case A1033622A for details on the other case.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain upper, Abnormal behaviour, Activities of daily living impaired, Affect lability, Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Arthralgia, Asthenopia, Bacterial test negative, Balance disorder, Blood iron
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood test normal, Chromatopsia, Confusional state, Conversion disorder, Crying
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Depression, Differential white blood cell count, Disorientation, Dissociation, Drug screen negative
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dysgraphia, Dyspnoea, Ear congestion, Ear discomfort, Electroencephalogram normal
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Encephalitis, Euphoric mood, Eye pain, Fatigue, Feeling abnormal
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Full blood count, Gait disturbance, Hallucination, Headache, Heart rate increased
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Hyperacusis, Hyperaesthesia, Hypertension, Hypoaesthesia, Lethargy
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Lumbar puncture normal, Malaise, Memory impairment, Meningeal disorder, Metabolic function test
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Mood swings, Motor dysfunction, Neck pain, Nervous system disorder, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pain, Pain in extremity, Panic attack, Paraesthesia, Paranoia
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Parosmia, Respiration abnormal, Sensation of heaviness, Social avoidant behaviour, Speech disorder
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Spinal pain, Suffocation feeling, Tachycardia, Throat tightness, Toxicologic test normal
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Vision blurred, Visual impairment, Vitamin B12, Walking aid user
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Conversion disorder, Dyspnoea, Hallucination, Hyperventilation, Laboratory test
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Psychiatric evaluation
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Encephalitis
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.), refers to a 16 year old female patient with amoxicillin allergy and with none pertinent medical history. On 03-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H017698 exp date 02-JUL-2015) (dose not reported, intramuscular route). Concomitant therapies included ATIVAN. It was reported that on 03-JUL-2013, the patient returned to the office about a half hour after receiving the first dose of GARDASIL, hysterical, hyperventilating, short of breath with hallucinations. The patient was sent to the emergency room. Laboratory diagnostic studies reported included unspecified laboratory tests with a psychiatric evaluation (results not reported). The outcome of hallucinations, short of breath, hyperventilating and hysterical was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 7/5 & 7/6 reports injection site was tender and slightly red then resolved. 7/14 reports site tenderness. 7/16 reported it to Employee Health.  Site with induration approx 3 in X 2 in, no increase in temp to touch, no redness but tender to touch. Medical Director notified.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Caesarean section, Computerised tomogram, Electroencephalogram, Exposure during pregnancy
Clinical narrative: Information has been received from a consumer for VARIVAX (merck), a Pregnancy Registry product, concerning a 19 year old daughter with drug allergy to sulfa, ABILIFY and prednisone who on 05-MAR-2012 was vaccinated with a dose of VARIVAX (merck), (dose and route not reported), (Lot# 671083/0826AA, exp date 02-JUN-2013). There was no concomitant medication. On an unknown date (shortly after vaccination) the patient learned that she was pregnant. The patient did not seek medical attention. No treatment was given for adverse event. At the time of the report the patient's status was not recovered. Additional information was received from patient. Patient delivered a healthy baby boy without any anomalies on 10-NOV-2012 at 39 weeks gestation. The infant was delivered C-section and weighed 9lbs., 6oz at birth. Patient said it was a difficult pregnancy with some preterm labor experienced but was able to carry her baby to full term. Patient also confirmed the VARIVAX (merck), vaccine given while pregnant was the first dose. No further information is available. Upon internal review the infant was delivered C-section was considered medically significant. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Threatened labour
Clinical narrative: Information has been received from a consumer for VARIVAX (merck), a Pregnancy Registry product, concerning a 19 year old daughter with drug allergy to sulfa, ABILIFY and prednisone who on 05-MAR-2012 was vaccinated with a dose of VARIVAX (merck), (dose and route not reported), (Lot# 671083/0826AA, exp date 02-JUN-2013). There was no concomitant medication. On an unknown date (shortly after vaccination) the patient learned that she was pregnant. The patient did not seek medical attention. No treatment was given for adverse event. At the time of the report the patient's status was not recovered. Additional information was received from patient. Patient delivered a healthy baby boy without any anomalies on 10-NOV-2012 at 39 weeks gestation. The infant was delivered C-section and weighed 9lbs., 6oz at birth. Patient said it was a difficult pregnancy with some preterm labor experienced but was able to carry her baby to full term. Patient also confirmed the VARIVAX (merck), vaccine given while pregnant was the first dose. No further information is available. Upon internal review the infant was delivered C-section was considered medically significant. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Bilirubin conjugated increased, Blood bilirubin increased, Blood lactate dehydrogenase increased, Blood smear test abnormal, Dizziness
Clinical narrative: 7-6 admit: 5-6 day h/o headache, dizziness, nausea, has h/o migraines. Occ blurry vision and scotomata. Thrombotic thrombocytopenia purpura requiring 5 days of plasmapheresis. Pt vaccinated on 6-25 for Tdap, MMR, varicella.
Age: 14.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Haematocrit decreased, Haemoglobin decreased, Haemolysis, Headache, Migraine
Clinical narrative: 7-6 admit: 5-6 day h/o headache, dizziness, nausea, has h/o migraines. Occ blurry vision and scotomata. Thrombotic thrombocytopenia purpura requiring 5 days of plasmapheresis. Pt vaccinated on 6-25 for Tdap, MMR, varicella.
Age: 14.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Nausea, Plasmapheresis, Platelet count decreased, Scotoma, Thrombotic thrombocytopenic purpura
Clinical narrative: 7-6 admit: 5-6 day h/o headache, dizziness, nausea, has h/o migraines. Occ blurry vision and scotomata. Thrombotic thrombocytopenia purpura requiring 5 days of plasmapheresis. Pt vaccinated on 6-25 for Tdap, MMR, varicella.
Age: 14.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Vision blurred
Clinical narrative: 7-6 admit: 5-6 day h/o headache, dizziness, nausea, has h/o migraines. Occ blurry vision and scotomata. Thrombotic thrombocytopenia purpura requiring 5 days of plasmapheresis. Pt vaccinated on 6-25 for Tdap, MMR, varicella.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash generalised, Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 1 year old male patient with no known allergies. On 28-MAY-2013 the patient was vaccinated with PROQUAD (Merck) 0,5 ml (subcutaneously, left thigh, lot number H020854, exp. date 26-MAY-2014). Concomitant therapies included albuterol sulfate(manufacturer unknown). On 19-JUN-2013 the patient experienced chickenpox-like rash all over and fever. The patient sought medical attention and visited office. No treatment was given. None of lab diagnostics were performed. The outcome of events reported was as not recovered/not resolved. Relatedness between vaccination with PROQUAD (Merck) and events was unknown. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 18 year old patient (unknown gender). On 12-JUL-2013 the patient was vaccinated with M-M-R II (Lot # 0952AA, expiration date 14-JUN-2013) (dose, frequency and route not reported). Concomitant therapy was not reported. It was reported that the patient was administered an expired dose of with M-M-R II. No adverse effects reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient with relevant medical history included arrhythmia. On 04-JUL-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously, lot # not reported, expiry date 06-MAR-2013. Concomitant therapies included TIKOSYN. Patient's relevant past drug history was unknown. The product had been quarantined, due to an unknown temperature excursion. The relevant laboratory data was unknown. At the time of report it was not known if she will continue to take ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot number not reported). The physician reported that the patient who received ZOSTAVAX was later diagnosed with shingles on an unspecified date. It was not known if the patient currently had active shingles. The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: As of 7-17-13, spoke with pt's mom, pt doing fine. No rash, no fever, no swelling at site.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Blood glucose normal, Dizziness, Syncope
Clinical narrative: Given first GARDASIL vaccine, reported dizziness about 5 minutes after vaccine was given. After 15 minutes the patient had fainting episode while lying on exam table. Blood pressure was normal. Glucose was 81. Urgent care was contact. Patient was transported down stairs to urgent care for further evaluation.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Started with redness and swelling of right arm and which progressed almost to a size of golf ball. Very painful and itchy but no fever. Mom gave MOTRIN and applied ice.