chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Asthma, Attention deficit/hyperactivity disorder, Hepatitis B antibody negative
Clinical narrative: This spontaneous report has been received from a physician and refers to a 19 year old female patient with asthma and without drug reactions or allergies. The patient's medical history included attention deficit/hyperactivity disorder. The patient received three unspecified Hepatitis B vaccines (manufacturer unknown) when she was "younger" and on 21-APR-2014 the patient had titers drawn for the hepatitis B and the results showed that the patient was not immune (related case # 1501USA006194). So the patient was administered RECOMBIVAX HB on the following dates: 0.5ml (physician confirmed that the patient was administered 0.5ml) of RECOMBIVAX HB (lot# J007946 and expiration date 24-MAR-2016) intramuscular on 22-APR-2014, an unspecified dose of RECOMBIVAX HB (lot# J007946 and expiration date 24-MAR-2016) intramuscular on 26-JUN-2014 (the second vaccine should be given on 22-MAY-2014) and the "pediatric version" (unspecified dose) of RECOMBIVAX HB (lot# K008334 and expiration date 09-JUN-2016) intramuscular on 29-DEC-2014 (the third vaccine should be given on 22-OCT-2014 and should be given as adult formulation, other than "pediatric version"). Concomitant therapies included methylphenidate. Additional information is not expected as the physician is not allowed to be contacted.
Age: 19.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Drug administered to patient of inappropriate age, Hepatitis B antibody negative
Clinical narrative: This spontaneous report has been received from a physician and refers to a female patient of unknown age without drug reactions or allergies. On unspecified dates the patient received three unspecified Hepatitis B vaccines (manufacturer unknown) when she was "younger" (dose, lot number not provided). Concomitant therapies at that time were not specified. On unknown dates the patient experienced asthma and attention deficit/hyperactivity disorder (ADHD). On 21-APR-2014 the patient had titers drawn for the hepatitis B and the results showed that the patient was not immune. Since the patient was not immune, the patient was administered RECOMBIVAX HB on the later dates (related case #: 1501USA004324). The outcome of these events was unknown. Additional information is not expected as the physician was not allowed to be contacted.
Age: 19.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Asthma, Attention deficit/hyperactivity disorder, Hepatitis B antibody negative
Clinical narrative: This spontaneous report has been received from a physician and refers to a female patient of unknown age without drug reactions or allergies. On unspecified dates the patient received three unspecified Hepatitis B vaccines (manufacturer unknown) when she was "younger" (dose, lot number not provided). Concomitant therapies at that time were not specified. On unknown dates the patient experienced asthma and attention deficit/hyperactivity disorder (ADHD). On 21-APR-2014 the patient had titers drawn for the hepatitis B and the results showed that the patient was not immune. Since the patient was not immune, the patient was administered RECOMBIVAX HB on the later dates (related case #: 1501USA004324). The outcome of these events was unknown. Additional information is not expected as the physician was not allowed to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a health worker and refers to some unspecified patients. Since 30-DEC-2014, doses of VARIVAX (Merck) which had been exposed to a temperature of 11 degrees F for 51 hours cumulatively had been administered to unspecified patients. Vaccine of VARIVAX (Merck) should be stored frozen between -58 degrees F and +5 degrees F. No adverse effects have been observed or reported. This is one of several reports from same reporter. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Swelling, X-ray abnormal
Clinical narrative: Patient has swelling and redness after shot administraton.
Age: 1.55
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Redness around the injectoin site.
Sex: F
Vaccine: HPV4
Symptoms: Platelet count normal, Rash erythematous
Clinical narrative: This spontaneous report as received from a physician assistant via a field representative refers to a female patient of 14 (age unit unspecified). On 28-NOV-2014 the patient was vaccinated with a dose of GARDASIL, intramuscular (strength 120 (unit unspecified), lot#, dose# and dose/frequency unspecified). On 05-JAN-2015 the patient experienced idiopathic purpura which contained a red rash on her buttocks as well as the front and back of both her legs. It was unspecified if the rash was on the patient's entire buttock or legs. It was unspecified which GARDASIL dose the patient experienced this adverse effect with and it was unspecified how many doses were received in total. The patient had not received further doses. On an unknown date, labs looking for idiopathic thrombocytopenia were performed which came out negative. The patient sought medical attention via physician assistant visit and dermatologist visit. The outcome of these events was not reported. The relationship between GARDASIL and the events was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Viral titre increased
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 65 year old male patient with allergy to penicillin. The patient had none medical history. In 2010, "5 years ago" the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, lot# and route unspecified). Concomitant therapies included aspirin, NASONEX and simvastatin (manufacturer unknown). The reporter stated "starting 2 or 3 years ago", in approximately 2012, the patient developed a "recurrent intermittent rash which comes and goes, lasts about a week and then completely goes away". The reporter stated that each time the patient developed a rash, unspecified locations. The patient was prescribed unspecified steroids for treatment. The patient was seen by the nurse practitioner on 02-JAN-2015 at which time the patient "had a rash and titers drawn". The titers showed the patient "positive for zoster". The reporter gave the patient unspecified steroids for treatment. The outcome of the events was not reported. The causality was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site reaction, Myalgia
Clinical narrative: This spontaneous report as received from consumer's wife regarding her husband of unknown age. The patient's concurrent condition included allergy to penicillin. On 09-JAN-2015 the patient was vaccinated with ZOSTAVAX (dose/frequency: 1 single shot) intramuscularly. Concomitant medications were unspecified by reporter. On an unknown date in January 2015, the patient's muscle at the injected arm was sore. No treatment was given for the event. Action taken with ZOSTAVAX was not reported. The outcome of the event was reported as not recovered/not resolved. The causal relationship between event and ZOSTAVAX was unknown. No further information was reported. This case# 1501USA008040 is linked to the case # 1501USA008948 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: This spontaneous report as received from a pharmacist via agency employee refers to some adult patients of unknown age and gender. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (dose, route, anatomical location and expiration date were not reported). On an unknown date, the reporter's hospital decided to administered the PREVNAR to those patients, as they were not responding to PNEUMOVAX 23. The outcome of the event was unknown. The relatedness between the event and the therapy with PNEUMOVAX 23 was not provided. Additional information is not expected, as the reporter was not willing for him/her or her/his doctor to be contacted to discuss further.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Patients medical history and current conditions were not provided. On an unknown date the patients were vaccinated with an improperly stored dose of GARDASIL (lot #, expiration date, dose and route were not reported). No concomitant medications were reported. Additional information is not expected because the reporter details were not provided.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On an unknown date in 2014 (reported as some time last year), the patient was vaccinated with dose one of GARDASIL (dose and frequency were not reported) intramuscularly. On 21-JAN-2015 the patient was in the reporting nurse's office and will receive the dose two of GARDASIL. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. On 22-JAN-2015, the patient was vaccinated with an expired dose of M-M-R II (lot #, dose and route were not reported) expiration date 08-NOV-2014. No adverse effects 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 pharmacist refers to a patient of unknown age and gender. Patient's medical history and current conditions were not provided. On an unknown date the patient was vaccinated with an expired dose of ZOSTAVAX (dose and route were not reported) lot # J008435, expiration date 11-OCT-2014, 19400 PFU. No concomitant medications were reported. No adverse effects were noted. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a other refers to patient of unknown age and gender. Patient medical history and concurrent condition was not reported. On 24-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 (lot # K010466, expiration date 23-MAR-2016) prefilled syringe (dose and frequency unknown) which were exposed to temperatures outside of the required temperature range. Concomitant medication was not reported. The reporter stated customer purchased two 10 packs of this item and did not disclose any patient information. Also reported, this product had been administered to 20 patients. The outcome of the event was unknown. Additional information is not expected as all correspondence has been received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. On unknown dates, since December 2014, the patients were vaccinated with improperly stored doses of GARDASIL (dose, route and lot numbers were not provided). No adverse effects were noted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Rash
Clinical narrative: This spontaneous report as received from a patient's mother via company representative refers to a currently 15 years old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient was vaccinated with the second dose of GARDASIL (dose, route of administration, anatomical location, lot # and expiration date were not reported). The patient's concomitant therapies were not reported. On an unknown date, after the second dose of GARDASIL, the patient experienced a rash and the patient generally was not feeling well for about 2-3 days. On an unknown date, the patient recovered from the events, but the therapy with GARDASIL was discontinued (the patient did not receive the third dose of GARDASIL). The relatedness between the events and the therapy with GARDASIL was not provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: This spontaneous report was received from a health professional via company representative and refers to a 15-year-old female patient. The patient had no pertinent medical history, no drug reactions and no allergies. On 23-OCT-2014, the patient was vaccinated with the first dose of GARDASIL (dose and anatomical location were not reported, lot # J011272, exp. date was not reported). After the vaccination the patient offered no complaints. There was no concomitant therapy. On 06-JAN-2015, the patient was vaccinated with the second dose of GARDASIL (dose and anatomical location were not reported, lot # K006960, exp. date was not reported). On 06-JAN-2015, in the evening, the patient experienced dizziness, nausea and headache. The patient's mother informed her physician that the patient sought medical attention in an unspecified emergency department of an unspecified facility. The patient was not admitted to the hospital and the reporter did not know if the patient received any treatments while in the emergency department. The patient recovered from the adverse events on an unspecified date, approximately in January 2015. The relatedness between vaccination with GARDASIL and the events was not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Patient was seen for 4 yr physical on 1-6-15 was given 4yr vaccine. (MMR, varicella, DTAP and IPV). Mother states had swelling and redness immediately after injection to right upper arm with MMR. Patient was seen today 1-9-15 and was givne cefdinir 250mg/5mL q 12 x 10 days. Patient to follow up next week.
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This report was received from Pfizer with manufacturer control number# 2015005953 on 21-JAN-2015. This report was originally received from a pharmacist, an elderly male in his sixties, regarding himself. The patient's medical history included receiving his second PREVNAR 7 booster dose about two years ago, when he was 62 or 63 years old. On an unknown date, one year ago, the pharmacist had the wrong vaccine administered to him, he had asked his doctor for PREVNAR 13 but his doctor gave him PNEUMOVAX 23 instead. This was an unusual regimen for the pharmacist. Limited information was available as the pharmacist disconnected the call before he could be transferred to medical information department. The outcome of wrong vaccine administration was unknown. Additional information is not expected since there was no request for medical information.
Sex: U
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot #, expiration date, dose and route of administration were not provided). No concomitant medications were reported. On an unknown date, the patient complained of pain after injection of GARDASIL. The outcome of the event was unknown. The relatedness between the event and the vaccination with GARDASIL was not provided. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 29-year-old female subject was enrolled in a study. The subject received BOOSTRIX (unknown) .5 ml on 20th November 2014. The subject received BOOSTRIX at week 38 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information received on 20 November 2014: The due date was unknown. The last menstrual period was not reported.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 31-year-old female subject was enrolled in an open label study: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during pregnancy or within 28 days preceding. The subject received the 1st dose of BOOSTRIX (intramuscular) .5 ml on 26th November 2014. The subject's last menstrual period was on 18th April 2014 and estimated date of delivery was 23rd January 2015. The subject received BOOSTRIX at week 32 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was going. Additional information received on 26 November 2014: It was unknown if the patient was using contraceptive method. The patient had one previous pregnancy with normal birth. It was also unknown if the child born with defect, if there was any maternal history which may have an impact on the outcome of this pregnancy and if the father had a relevant medical or family history. The last menstrual period was not reported but was calculated with the due date.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This female subject was enrolled in a study. The subject received BOOSTRIX (unknown) on an unknown date. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). Additional event(s) included incorrect storage of drug. The outcome of vaccine exposure during pregnancy was unknown. The outcome(s) of the additional event(s) included incorrect storage of drug (unknown). The pregnancy was ongoing. Additional information received on 05 December 2014: The vaccine may have been improperly stored. The due date, the gestational exposure and the last menstrual period were not reported. This is one of the 3 cases reported by the same reporter for the same vaccine.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 62-year-old female patient who received ENGERIX B (batch number 995J5, expiry date 6th February 2017). In December 2014, the patient received ENGERIX B. In December 2014, the patient received ENGERIX B. In December 2014, an unknown time after receiving ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: Office was sent a recall notification from their distributor regarding ENGERIX B and storage temperature. The office has already administered the vaccine to 5 adults. Reporter is not certain what type of excursion took place (high or low temperatures). At this time, no reports to the office have been received from the patients following vaccination. Vaccines were given this week. Follow-up received on 08 December 2014: Age added. Patient got ENGERIX B which was not stable. No adverse event reported.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 29-year-old female subject was enrolled in an open label study: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during pregnancy or within 28 days preceding conception. The subject received BOOSTRIX (intramuscular) .5 ml on 26th November 2014. The subject's last menstrual period was on 18th April and estimated date of delivery was 14th January 2015. The subject received BOOSTRIX at week 31 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information received on 05 December 2014: It was unknown if the patient was using contraceptive method. The type of conception was normal and there was no evidence of defect from prenatal testing. The patient had one previous pregnancy with normal birth and without birth defect. It was also unknown if there was any maternal history which may have an impact on the outcome of this pregnancy, if she experienced adverse event and if the father had a relevant medical or family history. The number of gestational weeks at vaccination was not reported but was calculated with the last menstrual period.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a health worker and refers to some unspecified patients. Since 30-DEC-2014, doses of PROQUAD (Merck) which had been exposed to a temperatures of 11 degrees F for 51 hours cumulatively (supported temperature excursion) had been administered to unspecified patients. Vaccine of PROQUAD (Merck) should be stored frozen between -58 degrees F and +5 degrees F. No adverse effects have been observed or reported. This is one of several reports from same reporter. Additional information has been requested.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Incorrect product storage
Clinical narrative: This is a prospective pregnancy case. This female subject was enrolled in a study. The subject received BOOSTRIX (unknown) on an unknown date. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). Additional event(s) included incorrect storage of drug. The outcome of vaccine exposure during pregnancy was unknown. The outcome(s) of the additional event(s) included incorrect storage of drug (unknown). The pregnancy was ongoing.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site warmth
Clinical narrative: Cellulitis, that is moderate, well demarcated, on the (RT) tricep, warm to touch, Measured 9 cm x 5 cm.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Incorrect product storage
Clinical narrative: This is a prospective pregnancy case. This female subject was enrolled in a study. The subject received BOOSTRIX (unknown) on an unknown date. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). Additional event(s) included incorrect storage of drug. The outcome of vaccine exposure during pregnancy was unknown. The outcome(s) of the additional event(s) included incorrect storage of drug (unknown). The pregnancy was ongoing. Additional information received on 05 December 2014: The vaccine may have been improperly stored. The due date, the gestational exposure and the last menstrual period were not reported. This is one of the 3 cases reported by the same reporter for the same vaccine.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 31-year-old female subject was enrolled in a study. The subject received BOOSTRIX (injection) .5 ml on 29th December 2014. The subject's last menstrual period was on 3rd June 2014 and estimated date of delivery was 10th March 2015. The subject received BOOSTRIX at week 29 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information received on 29 December 2014: The type of conception was normal (no in-vitro fertilization). The number of gestational weeks at vaccination was 29 weeks and 6 days.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 26-year-old female subject was enrolled in a study. The subject received BOOSTRIX (injection) .5 ml on 29 December 2014. The subject's past medical history included human papilloma virus infection and miscarriage. Concurrent medical conditions included gestational diabetes. The subject's last menstrual period was on 16th June 2014 and estimated date of delivery was 23rd March 2015. The subject received BOOSTRIX at week 28 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 27-year-old female subject was enrolled in a study. The subject received BOOSTRIX (injection) .5 ml on 12th December 2014. Concurrent medical conditions included gestational diabetes. The subject's last menstrual period was on 5th May 2014 and estimated date of delivery was 9th February 2015. The subject received BOOSTRIX at week 31 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information received on 12 December 2014: The type of conception was normal (no in-vitro fertilization). The number of gestational weeks at vaccination was 31 weeks and 4 days.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 23-year-old female subject was enrolled in an open label study titled BOOSTRIX Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during pregnancy or within 28 days preceding conception. The subject received BOOSTRIX (injection) .5ml on 29th December 2014. The subject's last menstrual period was on 19th May 2014 and estimated date of delivery was 23rd February 2015. The subject received BOOSTRIX at week 32 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information received on 29 December 2014: The type of conception was normal (no in-vitro fertilization).
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 38-year-old female subject was enrolled in a study. The subject received BOOSTRIX (intramuscular) .5 ml on 12th December 2014. The subject's last menstrual period was on 18th April 2014 and estimated date of delivery was 23rd January 2015. The subject received BOOSTRIX at week 34 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information received on 12 December 2014: The last menstrual period was not reported but was calculated with the due date. The type of conception was not reported.
Age: 40.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a consumer refers to an unspecified number of patients of 40 year old and unknown gender enrolled in a market research. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL (route, dosage, lot# and expiration date were not reported). Concomitant therapy was not reported. The consumer informed that on an unknown date a physician was discussing patients he vaccinated with GARDASIL and said that he vaccinated 40 years old people, which was potentially off label usage. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Eye pain
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. Patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (route, lot # and expiration date were not provided). On an unknown date, the patient was vaccinated with the second dose of GARDASIL (route, lot # and expiration date were not provided). Concomitant therapies information was not provided. The physician mentioned that on an unknown date, the patient developed eye pain, described as ocular pain, after receiving the second dose of GARDASIL. It was stated that the ocular pain began hours after the patient received GARDASIL. The patient sought medical attention through an office visit. On an unknown date, the patient recovered from ocular pain. Additional information has been requested.
Age: 50.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a consumer refers to an unspecified number of patients of 50 year old and unknown gender enrolled in a market research. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL (route, dosage, lot# and expiration date were not reported). Concomitant therapy was not reported. The consumer informed that on an unknown date a physician was discussing patients he vaccinated with GARDASIL and said that he vaccinated 50 years old people, which was potentially off label usage. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist, via a company representative, refers to a currently 65 years old female patient with hypertension. Medical and concurrent conditions were not reported. On an unknown date approximately in 2011 (reported as "about 4 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (administration route, lot number and expiration date were not reported). The reporting pharmacist stated that the patient was taking unspecified blood pressure medications (at the time of the report). On an unknown date (reported as "before last month"), the patient developed herpes zoster and was treated with an unspecified anti-viral. The outcome of herpes zoster was reported as recovered (the reporter stated that the patient was "doing fine now") on an unspecified date. Additional information is not expected because the reporter refuses to be contacted.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a pharmacist and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject had no previous pregnancies. On 18 June 2014, the subject received unspecified dose of BOOSTRIX (intramuscular, unknown injection site). Her last menstrual period was on 14 October 2013 and estimate date of delivery was on 20 July 2014. The subject was exposed to the vaccine during the third trimester. At the time of reporting, the pregnancy was ongoing. Follow-up received on 13 January 2015 from pharmacist: On an unknown date, the subject gave birth to a neonate. The pregnancy resulted in a live neonate with no apparent congenital anomaly. At the time of reporting no information regarding the method of delivery, the gender, the weight or Apgar score for baby were available.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 36-year-old female subject was enrolled in a study. The subject received the 1st dose of BOOSTRIX (unknown) on 23rd December 2014. The subject's last menstrual period was on 28th May 2014 and estimated date of delivery was 4th March 2015. The subject received BOOSTRIX at week 29 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information received on 31 December 2014: The type of conception was normal (no in-vitro fertilization). There was no evidence of a defect from prenatal testing. The number of gestational weeks was not reported but was calculated with the last menstrual period.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 22-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 9 September 2014, the subject received a dose of BOOSTRIX (intramuscular, administration site unknown). Her last menstrual period was on 24 December 2013 and estimated date of delivery on 10 October 2014. The subject was exposed to the vaccine during the third timester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 06 October 2014 from nurse: The VAERS details were provided. Some of the patient's details were updated. This has a normal conception pregnancy. Follow-up information received on 06 January 2015 from nurse: Concurrent medical conditinos included pollen allergy (z-pak). This was a normal conception. The subject received dTpa vaccine at week 35 4/7 of the pregnancy and during the third trimester of pregnancy. On 4th Octobet 2014 after 39 weeks, the subject gave birth to a [gender unknown] neonate via vaginal delivery. The pregnancy resulted in a live neonate with no apparent congenital anomaly. The neonate weighed 3900 grams (8lbs 10oz) at birth. The length, head circumference and Apgar score were unknown.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 39-year-old female subject was enrolled in a study. The subject received BOOSTRIX (intramuscular) on 5th January 2015. The subject's past medical history included live birth (The patient had 2 previous pregnancies with normal births). The subject's last menstrual period was on 2nd June 2014 and estimated date of delivery was 6th March 2015. The subject received BOOSTRIX at week 31 of the pregnancy and during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional information received on 13 January 2015: The type of conception was normal. There was no evidence of a defect from prenatal testing. The mother wasn't using contraception. The number of gestational weeks was not reported but was calculated with the last menstrual period.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Crying, Decreased appetite, Fatigue, Irritability, Middle insomnia
Clinical narrative: Cranky & clingy, no appetite, fever 102 on the night of the vaccine (which was Thursday). On Friday, his fever was lower (99) in the morning, but still very little appetite and cranky.  Later in the morning, he seemed normal again, but around lunch time still no appetite, fever returned and very tired.  After nap, he seemed normal again.  At supper, he didn't want to eat and got cranky again.  Normally, he sleeps fine through the night, but he woke up several times during the night crying out.  Now it is Saturday morning.  So far he seems okay.  I have been giving him Advil and applying lemon essential oil to his spine and lavender essential oil to the bottom of his feet.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Cranky & clingy, no appetite, fever 102 on the night of the vaccine (which was Thursday). On Friday, his fever was lower (99) in the morning, but still very little appetite and cranky.  Later in the morning, he seemed normal again, but around lunch time still no appetite, fever returned and very tired.  After nap, he seemed normal again.  At supper, he didn't want to eat and got cranky again.  Normally, he sleeps fine through the night, but he woke up several times during the night crying out.  Now it is Saturday morning.  So far he seems okay.  I have been giving him Advil and applying lemon essential oil to his spine and lavender essential oil to the bottom of his feet.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Fatigue, Rash, Urticaria
Clinical narrative: Hives /bumps, fatigue possible chicken pox.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Breath holding, Cyanosis, Hypotonia, Ocular hyperaemia, Respiratory arrest
Clinical narrative: My son was given the oral vaccination, then a few minutes later was administered another vaccination via a shot. The nurse had to leave the room as she pulled the safety on the second shot that was to be given, and in the time she was gone my son turned a dark shade of purple (he was only in his diaper) his eyes become blood shot red and he went limp and stopped breathing. I immediately picked him up, and began patting his back trying to get him to breath again. Within 10 seconds he began to breathe again and the nurse returned to the room and asked me what was wrong and I told her that he had stopped breathing and she said he was just holding his breath. I know he wasn't holding his breath as I have seen him hold his breath before. I strongly believe this was an adverse reaction to the vaccines he got. I am not sure on which vaccine this was, but I know it was the first shot he got of the 3 he received that day. He received these vaccinations: DTaP, IPV, HIB, Prevnar 13, hep B, and rotavirus.
Age: 67.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Amnesia, Feeling abnormal
Clinical narrative: 5 days after vaccination I was eating dinner and I felt very "strange" and I could not remember the name of the foods I was eating at that moment. After 10-15 minutes, I could remember the names of the food. I thought I was having a stroke.
Age: 67.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Memory impairment
Clinical narrative: 5 days after vaccination I was eating dinner and I felt very "strange" and I could not remember the name of the foods I was eating at that moment. After 10-15 minutes, I could remember the names of the food. I thought I was having a stroke.
Age: 67.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Amnesia, Feeling abnormal
Clinical narrative: Patient stated 5 days after receiving his flu vaccine he had a moment at dinner where he couldn't remember anything. States his research shows this was a possible side effect of vaccine and he wanted us to report it. 1/24/15 was first time patient contacted pharmacy.
Age: 67.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Memory impairment
Clinical narrative: Patient stated 5 days after receiving his flu vaccine he had a moment at dinner where he couldn't remember anything. States his research shows this was a possible side effect of vaccine and he wanted us to report it. 1/24/15 was first time patient contacted pharmacy.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Abortion spontaneous, Anaemia, Fibromyalgia, Maternal exposure before pregnancy, Neuropathy peripheral
Clinical narrative: I started losing sensation in my (R) hands and feet in 1999. I suffered a miscarriage 4/24/00 and 5/15/00 it was twins gestation.  The loss of sensation moved from (R) hands to both hands and arms and both legs and feet.  My regular doctors ran tests for years and are still running them as I type this to determine cause.  I have been diagnosed with neuropathy, fibromyagia, possible lupus and MS, severe anemia, among other things ...it wasn't until meeting with a naturalist recently and reading the effects of the anthrax vaccine today that I realized I may be undergoing all of this because of either taking the vaccine or not finishing the series. Prior to this I had been a very healthy person.  I not missed a day of high school and only 1.5 days from K-8 (1 day for my brother's graduation and .5 to appear on a show).
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Sensory loss
Clinical narrative: I started losing sensation in my (R) hands and feet in 1999. I suffered a miscarriage 4/24/00 and 5/15/00 it was twins gestation.  The loss of sensation moved from (R) hands to both hands and arms and both legs and feet.  My regular doctors ran tests for years and are still running them as I type this to determine cause.  I have been diagnosed with neuropathy, fibromyagia, possible lupus and MS, severe anemia, among other things ...it wasn't until meeting with a naturalist recently and reading the effects of the anthrax vaccine today that I realized I may be undergoing all of this because of either taking the vaccine or not finishing the series. Prior to this I had been a very healthy person.  I not missed a day of high school and only 1.5 days from K-8 (1 day for my brother's graduation and .5 to appear on a show).
Age: 1.09
Sex: M
Vaccine: DTAP
Symptoms: Dermatitis diaper, Diarrhoea, Vomiting projectile
Clinical narrative: Projectile vomiting 2-3 times per day for 7 days, no vomiting on day 8, 3 times on day 9 - began Zantac on day 9, ended Zantac on day 10, began Pepcid on day 11. Excessively loose stool. Severe diaper rash from loose stool requiring prescription diaper ointment.
Age: 27.0
Sex: F
Vaccine: FLUN4
Symptoms: Angiotensin converting enzyme increased, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Antinuclear antibody positive, Blood alkaline phosphatase increased
Clinical narrative: Intermittent action, postural and rest tremor of the limbs that persists.
Age: 27.0
Sex: F
Vaccine: FLUN4
Symptoms: Blood calcium normal, Blood glucose increased, Blood thyroid stimulating hormone normal, C-reactive protein increased, Full blood count normal
Clinical narrative: Intermittent action, postural and rest tremor of the limbs that persists.
Age: 27.0
Sex: F
Vaccine: FLUN4
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid factor negative, Tremor
Clinical narrative: Intermittent action, postural and rest tremor of the limbs that persists.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: RIGHT DELTOID AREA BECAME VERY RED, INDURATED, AND PAINFUL. IT IS WARM TO TOUCH AND PT C/O PAIN EXTENDING TO HER RIGHT POSTERIOR SHOULDER AREA.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pruritus
Clinical narrative: Local site reaction, redness, itching, back site reaction in a location of a previous shingles outbreak per patient.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Viral infection
Clinical narrative: Extremely high fever over 104F.  Every fever since then has been 104F or higher.
Age: 0.8
Sex: F
Vaccine: DTAP
Symptoms: Lethargy, Listless, Muscle rigidity, Pyrexia, Seizure
Clinical narrative: My daughter became rigid at first and then proceeded to convulse in my arms for at least 45 seconds at which time she projectile vomited.  She became listless and very lethargic and developed a fever.
Age: 0.8
Sex: F
Vaccine: DTAP
Symptoms: Vomiting projectile
Clinical narrative: My daughter became rigid at first and then proceeded to convulse in my arms for at least 45 seconds at which time she projectile vomited.  She became listless and very lethargic and developed a fever.
Age: 1.02
Sex: F
Vaccine: MMR
Symptoms: Decreased eye contact, Flat affect, Language disorder, Screaming
Clinical narrative: High pitched screaming, loss of eye contact, loss of expression, loss of expressive and receptive language.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Pt is experiencing ongoing shoulder pain well beyond area of vaccination.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 2 years old patient of unknown gender. On 20-OCT-2014, patient was vaccinated with an improperly stored dose of M-M-R II (lot# J016232, Expiry: 19-DEC-2015, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 12 months old patient of unknown gender. On 20-OCT-2014, patient was vaccinated with an improperly stored dose of M-M-R II (lot# J016232, Expiry: 19-DEC-2015, therapy type: HSA, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
Age: 1.07
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 12 months old patient of unknown gender. On 12-NOV-2014, patient was vaccinated with an improperly stored dose of M-M-R II (lot# J016232, Expiry: 19-DEC-2015, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
Age: 1.04
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 12 months old patient of unknown gender. On 15-OCT-2014, patient was vaccinated with an improperly stored dose of MMR II (lot# J016232, Expiry: 19-DEC-2015, therapy type: HSA, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
Age: 1.03
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 12 months old patient of unknown gender. On 07-NOV-2014, patient was vaccinated with an improperly stored dose of M-M-R II (lot# J016232, Expiry: 19-DEC-2015, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MMRV, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.