chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 04 April 2013. A 29-year-old female patient, whose medical history and concomitant medications were not reported, has received intramuscular first dose of ADACEL lot number: U4612AA (Anatomical site of vaccination was not reported) on 04 April 2013. The patient was pregnant during vaccination. The patient's last menstrual period was reported as 16 August 2012 and the expected date of delivery is 31 May 2013. As per reporter the patient did not experienced any adverse event. List of documents held by sender none.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. Since 05-JAN-2015, the patients was vaccinated with PROQUAD (Merck) (strength, dose, lot # were not reported) which were exposed to supported temperature excursion. Concomitant therapy was not reported. No adverse effect was reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a 64 year old female patient with none pertinent medical history and none drug reactions/allergies referring to herself. On 19-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (route, lot#, dose and frequency unknown). There was none concomitant medication. On 21-JAN-2015, the patient experienced pain and soreness, redness and warm at the injection site and a headache. The patient also stated that the redness was bigger than a 50 cent piece. There was no treatment given for the adverse events. None lab diagnostics studies were performed. The patient sought medical attention via calling pharmacist. The outcome of the adverse events was reported as not recovered/not resolved. The relationship of the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 23-JAN-2015 the patient was inadvertently vaccinated with expired ZOSTAVAX (expiry date: 21-JAN-2015) (dose, lot number and route was unknown). No adverse effects were reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 16 April 2013. A 19-year-old female patient, had received intramuscular first dose of ADACEL vaccine batch number U4431BA (anatomical site of vaccination was not reported) on 16 April 2013. The patient was seen in emergency room for laceration on unspecified date. Patient's concomitant medications were not reported. The patient received vaccine during pregnancy. The patient's last menstrual period was unknown. The expected date of delivery (EDD) was reported as 11 June 2013. The patient did not experience any adverse event. List of documents held by sender: none.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 09 April 2013. A 41-year-old female patient, with no medical history and whose concomitant medications were not reported, had received intramuscular first dose of ADACEL lot number: U4431AA (Anatomical site of vaccination was not reported) on 09 April 2013. The patient was pregnant during vaccination. Date of last menstrual period was reported as 07 August 2012 and the estimated date of delivery was 14 May 2013. At the time of the report, the patient had not experienced any adverse events. The patient's health during pregnancy, specific risk factors (e.g.: alcohol, tobacco or recreational drugs) was not reported. Treatment for infertility was not reported. As per reporter the patient did not experienced any adverse event. List of documents held by the sender none.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 09 April 2013. A 31-year-old female patient, who had no medical history, had received intramuscular first dose of ADACEL (lot number: C4366AA, site of vaccination was not reported) on 09 April 2013. The patient was pregnant during vaccination. The patient's date of last menstrual period was reported as 08 September 2012 and the estimated date of delivery is 25 June 2013. At the time of the report, the patient had not experienced any adverse event. List of documents held by sender none. Follow-up information received from a healthcare professional on 19 August 2013: The patient had chronic gastritis at the time of vaccination. The patient also had nausea and GERD (Gastro Esophageal Reflux disease). The patient was taking ZOFRAN 8 mg for nausea and PROTINIX 40 mg for Nausea/GERD. The patient had not received any treatment for infertility. The patient had no previous pregnancies. The patient had no family history of congenital anomaly. The patient received ADACEL in left deltoid. The patient had no any risk factors during pregnancy. The patient's pre-pregnancy weight was 237 lbs. and height was 5.4 feet while weight at delivery was 245 lbs. The prenatal test done on an unspecified date revealed normal results. At 39 weeks of gestation, the patient delivered a female child weighing 4/02 kg. The height of the baby was 51 cm and APGAR score at 1 minute was 9 and at 5 minute was 10. The baby had no any congenital anomaly.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 05 April 2013. A 36-year-old female patient had received first intramuscular dose of ADACEL vaccine (Lot number U4612AA, anatomical site of vaccination was not reported) on 05 April 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 29 August 2012 and the expected date of delivery was reported as 05 June 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. As of 05 April 2013, the patient did not experience any adverse event. List of documents held by the sender: None.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 03 April 2013. A 32-year-old pregnant female patient whose medical history was reported as "not applicable and concomitant medications were not reported, had received an intramuscular first dose of ADACEL batch number U4431AA (Anatomical site of administration was not reported0 on 02 April 2013. The patient's last menstrual period date was reported as 02 August 2012 and the expected date of delivery is 09 May 2013. The patient did not experience any adverse event. Documents held by the sender: None.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 26 March 2013. A 30-year-old female patient, had received a dose 1 of ADACEL vaccine (lot number: U4612AA, site of vaccination was not reported) intramuscularly on 26 March 2013. The patient was pregnant at the time of vaccination. The last menstrual period was on 17 July 2012. The patient's estimated date of delivery was reported as 23 April 2013. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. As of 26 March 2013, the patient had not experienced any adverse events. As of 26 March 2013, the patient's outcome was unknown. Documents held by sender: none.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On 16-JAN-2015 the patient was prescribed to receive a dose of ZOSTAVAX but received VARIVAX (Merck) (lot# unknown) 0.5 ml, subcutaneously instead. No adverse experience reported. The outcome and action taken were not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles
Clinical narrative: This spontaneous report has been received from a pharmacist according to an unspecified website concerning an unknown number patients of unknown age and gender. On an unknown date the patients were diagnosed with measles even though they had received an unspecified number of doses of M-M-R II (dose, route, lot# and received dates unknown). The outcome of the events was not provided. No production quality complaint was reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a male patient of unknown age referring to himself. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiration date, dose and route unspecified). On an unknown date the patient was vaccinated with second (extra) dose of PNEUMOVAX 23 (lot number, expiration date, dose and route unspecified), even though he was not considered high risk. No adverse event was reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Measles antibody negative, Mumps antibody test negative, Pregnancy test, Rubella antibody negative
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 07-JAN-2015, the patient was subcutaneously vaccinated with M-M-R II (dose, anatomical location, lot# and exp.date were not reported) because MMRII titers, which were drawn on an unspecified date, were negative. It was unknown if and when the patient received M-M-R II in the past. The patient performed a home pregnancy test on an unspecified date, results were not reported. The patient found that she was pregnant on 09-JAN-2015. The date of last menstrual period and the estimated delivery date were unknown. The outcome of the event was unknown. The relatedness between vaccination with M-M-R II and negative MMRII titers was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from other health professional via a company representative refers to an approximately 60 year old female patient. The medical history and current conditions were unspecified. On an unknown date in January 2013 the patient was vaccinated with ZOSTAVAX dose 1 (route unspecified). Concomitant medications were not reported. On an unknown date sometime in January 2015, the patient was vaccinated with dose 2 of ZOSTAVAX. The patient did not experience any adverse reaction from the first or second dose of ZOSTAVAX. The patient did not seek any medical attention and no treatment was rendered. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 22 March 2013. A 26-year-old female patient, had received an intramuscular dose of ADACEL (lot number: U4586AA and site of administration was not reported) on 21 March 2013. The patient's health during pregnancy, specific risk factors (e.g. alcohol, tobacco or recreational drugs) and treatment for infertility were reported as "Not Applicable". Concomitant medications were not reported. The patient's menstrual period was 03 July 2012 and estimated date of delivery was reported as 09 April 2013. As per reporter the patient had not experienced any adverse event. Documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 08 May 2013. A 37-year-old female patient, whose medical history and concomitant medications were not reported, had received a first intramuscular dose of ADACEL vaccine, (lot number: U4612AA, and site of vaccination was not reported) on 08 May 2013. The date of last menstrual period was on 24 August 2012. The patient's estimated date of delivery was reported as 31 May 2013. At the time of this report, the patient had not experienced any adverse event. The patient's health during pregnancy, specific risk factors (e.g.: alcohol, tobacco or recreational drugs) was not reported. Treatment for infertility was not reported. Documents held by sender: none.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to unspecified patients of unkonwn age and gender. No pertinent medical history was reported. Since 05-JAN-2015, the patients was vaccinated with VARIVAX (Merck) (strength, dose, lot # were not reported) which were exposed to supported temperature excursion. Concomitant therapy was not reported. No adverse effect was reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 22 March 2013. A 30-year-old female patient, whose medical history and concomitant medications were not reported, had received intramuscular first dose of ADACEL vaccine lot number: U4612AA (Anatomical site of vaccination was not reported) on 21 March 2013. The patient was pregnant during vaccination. The patient's last menstrual period was reported as 07 July 2012 and the estimated date os delivery is 13 April 2013. As per reporter the patient did not experienced any adverse event.  Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Local reaction, Pruritus
Clinical narrative: Patient c/o intense itching shortly after MMR injection. Ice applied. Reaction remained local. Take to E.R. for evaluation.
Age: 36.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 21 March 2013. A 36-year-old pregnant female patient had received intramuscular first dose of ADACEL (Lot number: U4586AA, site of vaccination was not reported) on 20 March 2013. The patient's last menstrual period was on 01 August 2012 The patient's estimated date of delivery was reported as 8 May 2013. As per reporter, the patient had no experienced any adverse event. The patient's health during pregnancy, concomitant medications, medical history and risk factors were reported as "not applicable". Documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 20 March 2013. A 36-year-old female patient, had received dose 1 of ADACEL (Lot number: U4586AA, site of vaccination was not reported) intramuscularly on 20 March 2013. The last menstrual period was on 01 August 2012. The patient's estimated date of delivery was reported as 08 May 2013. As of 20 March 2013, the patient had not experienced any adverse events. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. As of 20 March 2013, the patient's outcome was unknown. Documents held by sender: none.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Pain in extremity, Peripheral swelling
Clinical narrative: Sore, painful, swelling at the beginning (3 to 4 days) then bruise (arm) - around 10 days. Patient is being monitored by physician's office because patient takes blood thinner medication.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Malaise, Rash pustular
Clinical narrative: Started 1-15-15. Scattered pustules, malaise (noted a few days after sib with same). Received: varicella in our office 06-14-07, on CHIRP 08-17-11, 4-12-12.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 20 March 2013. A 28-year-old female patient had received first dose of ADACEL vaccine (Lot number: U4586AA, site of vaccination was not reported) intramuscularly on 20 March 2013. At the time of vaccination the patient was pregnant. The patient's last menstrual period was on 18 June 2012. The patient's estimated date of delivery was reported as 09 April 2013. The patient's health during pregnancy, concomitant medications, medical history and risk factors were reported as "not applicable". As of 21 March 2013, the patient had not experience any adverse events. As of 21 March 2013, the patient's outcome was unknown. Documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Malaise, Rash pustular
Clinical narrative: Started 1-12-15. Scattered pustules, malaise (a few days later sib had same). Received varicella in our office 1-26-06, 08-05-09.
Age: 1.03
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Polymerase chain reaction, Varicella virus test positive
Clinical narrative: Patient was positive for VZV by PCR 1/15/15.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 19 March 2013. A 35-year-old female patient had received first dose of ADACEL vaccine (lot number: U4431AA, site of vaccination was not reported) intramuscularly on 19 March 2013. The patient's last menstrual period was on 20 August 2012. The patient's estimated date of delivery was reported as 27 May 2013. The patient's health during pregnancy, concomitant medications, medical history and risk factors were reported as "not applicable". As of 19 March 2013, the patient had not experienced any adverse events. As of 19 March 2013, the patient's outcome was unknown. Documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient began with significant soreness that progressed into severe arm pain with decreased range of motion. On morning of 1/27/15 she reported some relief of symptoms. Been taking ibuprofen. Not reported to pharmacy until 1/27/15.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 18 March 2013. A 33-year-old female patient, whose medical history and concomitant medications were not reported, received a first intramuscular dose of ADACEL vaccine (Lot number: U4586AA and site of vaccination was not reported) on 18 March 2013. The patient was pregnant at the time of vaccination. Patient's last menstrual period date was on 28 July 2012 and estimated date of delivery was reported as 06 April 2013. The patient's health during pregnancy and risk factors was reported as "not applicable". At the time of this report, the patient had not experienced any adverse event. Documents held by sender: none.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: On 12/12/14, I had the PNEUMOVAX 23 vial shot in my left arm. From that time on my arm has been in pain from the spot where I received the shot to my wrist. This pain is there 24/7. I have been seen by Dr's and all they can say is it will take all time to sometimes to heal.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On 05-JAN-2015, the patients was vaccinated with GARDASIL (dose, lot number and frequency was unknown) which underwent unsupported temperature excursions. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of the several reports received from the same source. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On 05-JAN-2015, the patients was vaccinated with PEDVAXHIB (dose, lot number and frequency was unknown) which underwent unsupported temperature excursions. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of the several reports received from the same source. No further information provided. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 30 April 2013.  A 28-year-old female patient had received an intramuscular first dose of ADACEL vaccine (lot number: U4612AA, anatomical site of vaccination was not reported) on 30 April 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 03 September 2012 and estimated delivery date was reported as 10 June 2013. The patient's health during pregnancy, medical history, risk factors and concomitant medications were not reported. As of 30 April 2013, the patient had not experienced any adverse events. Documents held by sender: none.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On 05-JAN-2015, the patients was vaccinated with RECOMBIVAX HB (dose, lot number and route was unknown) which underwent unsupported temperature excursions. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. This is one of the several reports received from the same source. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. On 22-JAN-2015, the patient was inadvertently vaccinated with ZOSTAVAX (route and dose unspecified) which was expired on 17-JAN-2015. No adverse effect was reported. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Clostridium test negative, Corynebacterium test negative, Full blood count normal, Immunoglobulins normal, Injection site erythema
Clinical narrative: Information has been received from a physician referring to a 39 years old female patient with recurrent sinusitis, thyroiditis and vertigo. The patient's medical history included seven times sinus surgery, pernicious anemia and shortness of breath (all medical history developed on unspecified dates). The patient developed lip tingling with AVELOX on an unspecified date. On 05-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 injection, (lot number and expiry date were not reported), intramuscular. 0.5 ml, for "immune deficiency evaluation". Concomitant therapies included cyanocobalamin. On 05-JAN-2015, the patient developed a fever "up to 103F" within "about 5 hours" after receiving PNEUMOVAX 23. The patient went to Hospital emergency room. on 06-JAN-2015, because of her fever, and she was started on KEFLEX 500mg. On an unspecified date, the patient was prescribed prednisone and ADVIL. On 08-JAN-2015, the patient had the following labs: titers for tetanus and diphtheria which resulted "normal", full blood count (CBC), immunoglobulin which resulted "normal", and titers for PNEUMOVAX which showed that she was reactive to 3 serotypes out of the 23 serotypes in PNEUMOVAX 23. On an unspecified date in January 2015, the patient developed erythema which measured "3.5cm by 2.5cm" and edema which measured "9 by 9" on her left arm at the injection site where she received the PNEUMOVAX 23. The patient had a significant disability on 12-JAN-2015 (reported as "yesterday") in which she was unable to move her arm due to the edema. On 12-JAN-2015, the physician started the patient on clindamycin. On 13-JAN-2015, (reported as "today"), the patient called the physician's office to report that she was "much better" and the patient did not have a fever on the same day. The outcome of erythema and edema at the injection site were reported as recovering. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Pyrexia, Streptococcus test positive
Clinical narrative: Information has been received from a physician referring to a 39 years old female patient with recurrent sinusitis, thyroiditis and vertigo. The patient's medical history included seven times sinus surgery, pernicious anemia and shortness of breath (all medical history developed on unspecified dates). The patient developed lip tingling with AVELOX on an unspecified date. On 05-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 injection, (lot number and expiry date were not reported), intramuscular. 0.5 ml, for "immune deficiency evaluation". Concomitant therapies included cyanocobalamin. On 05-JAN-2015, the patient developed a fever "up to 103F" within "about 5 hours" after receiving PNEUMOVAX 23. The patient went to Hospital emergency room. on 06-JAN-2015, because of her fever, and she was started on KEFLEX 500mg. On an unspecified date, the patient was prescribed prednisone and ADVIL. On 08-JAN-2015, the patient had the following labs: titers for tetanus and diphtheria which resulted "normal", full blood count (CBC), immunoglobulin which resulted "normal", and titers for PNEUMOVAX which showed that she was reactive to 3 serotypes out of the 23 serotypes in PNEUMOVAX 23. On an unspecified date in January 2015, the patient developed erythema which measured "3.5cm by 2.5cm" and edema which measured "9 by 9" on her left arm at the injection site where she received the PNEUMOVAX 23. The patient had a significant disability on 12-JAN-2015 (reported as "yesterday") in which she was unable to move her arm due to the edema. On 12-JAN-2015, the physician started the patient on clindamycin. On 13-JAN-2015, (reported as "today"), the patient called the physician's office to report that she was "much better" and the patient did not have a fever on the same day. The outcome of erythema and edema at the injection site were reported as recovering. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a health care professional on 08 May 2013. A 27-yearold pregnant female patient, had received first intramuscular dose of ADCEL vaccine (Lot number: C4366AA in right deltoid) on 08 May 2013. Patient's last menstrual period was reported on 23 October 2012. The estimated date of delivery was reported as 31 July 2013. As of 08 May 2013, the patient had not experienced any adverse event. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. Documents held by sender: none.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 67 year old male patient with no pertinent medical history or concurrent conditions who on 22-JAN-2015 was vaccinated with a dose of ZOSTAVAX lot # J013133 that had expired on 17-JAN-2015. No adverse events were reported. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 01 May 2013. A 33-year-old female patient had received first intramuscular dose of ADACEL (Lot number: U4612AA, anatomical site of vaccination was not reported) on 01 May 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 15 October 2012 and the expected date of delivery is 22 July 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. As of 01 May 2013, the patient did not experience any adverse event. List of documents held by the sender: None.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 07 June 2013. A 36-year old female patient had received an intramuscular dose 1 of ADACEL vaccine (Lot number: C4418BA, site of vaccination was not reproted) on 18 May 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was unknown. The patient's estimated date of delivery was 15 June and medical history were not reported. The patient had not received any treatment for infertility. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 09 May 2013. A 30-year-old female patient had received first dose of ADACEL vaccine (lot number: U4612AA, anatomical site of vaccination was not reported) intramuscularly on 08 May 2013. The patient was pregnant at the time of vaccination. The patient's medical history, risk factors (e.g.: alcohol, tobacco or recreational drugs) and concomitant medications were not reported. The patient's last menstrual period date was on 26 September 2012 and the expected delivery date was reported as 03 July 2013. At the time of this report, the patient did not experience any adverse event. List of documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 06 May 2013. A 25-year-old female patient had received first intramuscular dose of ADACEL (Lot number U4612AA, anatomical site of vaccination not reported) on 01 May 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 17 September 2012 and the expected date of delivery is 24 June 2013. Pre-natal tests were not done. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as not applicable. As of 06 May 2013, the patient did not experience any adverse event. List of documents held by the sender: None.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 10 June 2013. A 34-year-old female patient had received an intramuscular 0.5 ml dose of ADACEL vaccine (Lot number: U4612AA, dose number not reported) in right deltoid region on 10 June 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 07 November 2012. The estimated date of delivery was reported as 14 August 2013. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. At the time of this report, the patient had not experienced any adverse event. Documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 06 May 2013. A 33-year-old female patient had received an intramuscular dose 1 of ADACEL (lot number U4612AA, anatomical site of vaccination not reported) on 01 May 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 15 August 2012 and the expected date of delivery is 22 May 2013. Prenatal tests were not done. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as not applicable. As of 06 May 2013, the patient did not experience any adverse event. List of documents held by the sender: None.
Sex: M
Vaccine: TDAP
Symptoms: Foetal exposure during pregnancy, Foetal growth restriction
Clinical narrative: This case is linked with case number 2012-07324 (mother case). Initial report received from healthcare professionals on 08 May 2013. A male patient, whose weight was 2.36 kg and height was 48.3 cm and was delivered on 16 February 2013 had exposed of ADACEL vaccine via transplacental (lot number unknown) on 11 June 2012. The patient's personal history, family history and concomitant medications were not reported. As per reporter, the patient had intrauterine growth retardation (IUGR). The patient laboratory tests and corrective treatments were not reported. At the time of this report, the outcome of event was not reported. Documents held by sender were none.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 24 May 2013. A 28-year-old female patient had received an intramuscular first dose of ADACEL vaccine (Lot no: C4366AA, site of vaccination was not reported) on 24 May 2013. The patient was pregnant at the time of vaccination. Patient's date of last menstrual period was 01 September 2012 and the estimated date of delivery was reported as 08 June 2013. The patient's health during pregnancy, specific risk factors (e.g.: alcohol, tobacco or recreational drugs), treatment for infertility, medical history, prenatal tests and concomitant medications were not reported. As of 24 May 2013, the patient had no adverse event. Documents held by sender: none.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist assistant refers to a patient of unknown age and gender. No medical history or current condition were reported. On 23-OCT-2014, the patient was vaccinated with a first dose of GARDASIL (lot number and expiry date were not provided) 0.5 ml, intramuscular. On 29-MAY-2014, the patient was vaccinated with a second dose of GARDASIL (lot number and expiry date were not provided) 0.5 ml, intramuscular. On 31-OCT-2014, the patient was vaccinated with a third dose of GARDASIL (lot number and expiry date were not provided) 0.5 ml, intramuscular. On 25-JAN-2015, the patient was vaccinated with a fourth dose of GARDASIL (lot number and expiry date were not provided) 0.5 ml, intramuscular. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 21 June 2013. A 20-year old female patient had received an intramuscular dose 1 of ADACEL (batch number: U4612AA and site of administration was not reported) on 21 June 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 01 November 2012. The estimated date of delivery was 08 August 2013. The patient's health during pregnancy, risk factors, concomitant medications, treatment for infertility and medical history were not reported. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 28 May 2013. A 35-year-old female patient, whose medical history and concomitant medications were not reported, had received intramuscular 0.5 ml first dose of ADACEL lot number: U4512AA (Expiry date 09/20/2015) in right deltoid on 28 May 2013. The patient received vaccine during her pregnancy. The patient's last menstrual period date was reported as 17 September 2012 and the expected date of delivery is 09 July 2013. The gestation week was calculated as 34 weeks. The patient did not experienced any adverse event. List of documents held by sender: none.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 08 May 2013. A 28-year-old female patient had received an intramuscular 0.5ml dose of ADACEL (Lot number: U4612AA, Exp. date: 20-Sep-2015) in right deltoid on 08 May 2013. The patient was pregnant at the time of vaccination. The date of last menstrual period was 27 September 2012 and the expected date of delivery was 04 July 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. As of 08 May 2013, the patient did not experience any adverse event. List of documents held by the sender: None.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a healthcare professional on 07 June 2013. A 35-year-old female patient had received intramuscular dose 1 of ADACEL (Lot number U4612AA) in left deltoid on 07 June 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 11 October 2012 and the expected date of delivery is 18 July 2013. At the time of the report, the patient had not experienced any adverse event. The patient's health during pregnancy, risk factors were not reported. Concomitant medications and past medical history was not reported. Treatment for infertility was not reported. List of documents held by the sender: None.
Sex: F
Vaccine: MMR
Symptoms: Breast feeding, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On 17-JAN-2015 (reported as about 1 week ago) the patient was vaccinated with M-M-R II, 0.5 ml, subcutaneous. Concomitant medication was not reported. The patient who was breastfeeding was administered with M-M-R II. No adverse effects reported. The outcome of the event was unknown. The reporter considered the event to be not related to M-M-R II. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 07 June 2013. A 29-year-old female patient had received an intramuscular dose 1 of ADACEL (lot number: U4612AA, exp. date: 9-10-15, anatomical site of administration was not reported) on 07 June 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 04 November 2012. The estimated date of delivery was reported as 11 August 2013. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. At the time of this report, the patient had not experienced any adverse event. Documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 11 June 2013. A 37-year-old female patient had received an intramuscular first dose of ADACEL (Lot number: U4612AA, anatomical site of administration was not reported) on 11 June 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 15 November 2012. The estimated date of delivery was reported as 16 August 2013. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. As of 11 June 2013, the patient had not experienced any adverse event. Documents held by sender: none.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (reported as immunization coordinator) refers to 2 patients of unknown age and gender. No information about medical history, concurrent conditions were reported. On an unknown date the patients were vaccinated with VARIVAX (Merck) (dose strength, route not reported) that was stored improperly (Incorrect product storage). No adverse effects reported (No adverse event). No concomitant therapy was reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 28.0
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 28 year old patient. On an unknown date the patient was vaccinated with a dose of PROQUAD (Merck) 0.5 ml (lot number not reported, subcutaneous) and a dose of VARIVAX (Merck) 0.5 ml (lot number not reported, subcutaneously) instead of a dose of VARIVAX (Merck) and a dose of M-M-R II (dose, strength, lot number not reported). No adverse events were reported. No product quality complaint was involved. Additional information is not expected as we're not allowed to contact physician.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. On 21-JAN-2015 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot number not provided), 0.5 ml, intramuscular. No adverse effect was reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient got shingles vaccine in 2011, she now has shingles.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cellulitis, Injection site bruising, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient developed 7 cm erythematous patch at injection site (right thigh) of DTAP and IPV. Indurated and warm with mild bruising. No fever, able to walk and move leg freely. Treated with KEFLEX for mild cellulitis as not improved at day 3.
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: This spontaneous report as received from a other nurse practitioner via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 1, (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patient experienced hives and rash after receiving her second dose of GARDASIL. The patient sought medical attention and made a phone call to the nurse practitioner on an unknown date. The patient did not receive any treatment for the events. The outcome of hives and rash was unknown. The action taken with the therapy with GARDASIL was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. No product quality complaint was reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Received KINRIX and PROQUAD on 1/13/15. Wed. morning mom noticed large red, raised spot at injection site on Rt thigh with redness all around it. It was hot to touch. Mom gave her BENADRYL for itching. Was bigger by Fri 1/16 when she was seen.
Age: 1.65
Sex: F
Vaccine: HEPA
Symptoms: Crying, Diarrhoea, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Mom reports started having diarrhea x 1 and vomiting several times. Had 4 Bm's x 5 days afterwards. Reports fever 104 degrees F and "red pinpoint rash" all over her body. Reports crying and was itching. 1st symptoms started day after Hep A given. No tc except "cream given and issue resolved.
Age: 1.65
Sex: F
Vaccine: HEPA
Symptoms: Rash pruritic, Vomiting
Clinical narrative: Mom reports started having diarrhea x 1 and vomiting several times. Had 4 Bm's x 5 days afterwards. Reports fever 104 degrees F and "red pinpoint rash" all over her body. Reports crying and was itching. 1st symptoms started day after Hep A given. No tc except "cream given and issue resolved.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. The pharmacist reproted that on, 26-JAN-2015 (reported as "today"), the patient was vaccinated with expired dose of PNEUMOVAX 23 lot # J010332, expiration date: 14-JAN-2015, 0.5 ml, intramuscular in the left deltoid. No adverse effects were reported. Additional information is not expected because the reporter did not wish to be contacted.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient developed hives 1 hour after receiving vaccines on 1/26/15: mom was advised to give BENADRYL.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial information received from a healthcare professional on 03 June 2013. A 25-year-old female patient, had received an intramuscular dose 1 of ADACEL (Lot number C4311AA) on 06 March 2013. The patient's last menstrual period date was on 03 March 2013 and estimated delivery date was reported as 08 December 2013. At the time of the report, the patient had not experienced any adverse events. The patient's health during pregnancy, specific risk factors (e.g. : alcohol, tobacco or recreational drugs) was none. Treatment for infertility was not reported. Concomitant medications were not reported. At the time of this report, the patient's outcome was unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 09 October 2013. The patient receive ADACEL on 03 June 2013. The patient was concomitantly receiving CELEXA 40 mg daily. The patient has history of dog bite.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received on 10 June 2013 and follow-up information received on 12 June 2013 and 13 June 2013 from a healthcare professional. An adult female patient, whose medical history was not reported, had received an intramuscular dose 1 of ADACEL (Lot number U4612AN, anatomical site of vaccination was not reported) on an unspecified date. The last menstrual period date was 22 November 2012 and the expected date of delivery is 25 August 2013. As per reporter the patient had no adverse event. List of documents held by the sender: None.
Age: 23.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Exposure during pregnancy, Laboratory test normal, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 12 JUNE 2013. A 23-year-old female patient had received an intramuscular dose 1 of MENACTRA (lot number: U4594AB, site of vaccination was not reported) and an intramuscular dose 1 of ADACEL (lot number: U4612AA, site of vaccination was not reported), both on 12 JUNE 2013. It was reported that the patient was pregnant at the time of vaccination. The last menstrual period date was 27 MAY 2013. The patient's estimated date of delivery was 03 MARCH 2014. The patient had no risk factors (e.g. alcohol, tobacco, or recreational drugs). Concomitant medications and medical history were not reported. The patient had not received any treatment for infertility. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none. Follow up information received from a healthcare professional on 12 JULY 2013. The patients address details were updated. The patient had no illness at the time of vaccination and had no previous pregnancy. The patient had received 0.5 ml dose of each ADACEL and MENACTRA vaccines. Initial laboratory tests were normal, further prenatal testing to be done at patient's chosen OB/GYN. The patient had no complications in pregnancy.