chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4, MMR
Symptoms: Maternal exposure during pregnancy, Placenta praevia, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female patient who on 13-JAN-2012, was vaccinated with a dose of GARDASIL (dose, route, lot number not reported). Secondary therapy included MMR II (dose, route, lot number not reported). The patient received MMR II and GARDASIL on 13-JAN-2012, and then discovered she was pregnant. The patient's last menstrual period was on 08-DEC-2011. Estimated delivery date would be 13-SEP-2012. On an unknown date, in 2012, an ultrasound was performed and the patient was diagnosed to have partial placenta previa. The registered nurse stated that the partial placenta previa was probably not due to the vaccinations. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Follow-up information has been received from a registered nurse via initial pregnancy questionnaire for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female patient with history of anemia and no history of previous pregnancies, full term deliveries, pre-term deliveries, spontaneous abortions, elective terminations, fetal deaths and no obstetric history of birth defects or infant complications in previous pregnancies, who on 13-JAN-2012, was vaccinated with a first dose of GARDASIL (lot number 670049/1171AA) (dose, route not reported). Secondary therapy included MMR II, 0.5 ml (lot number 671483/1008AA) (route not reported). Concomitant therapy included vitamins (unspecified) (one dose daily, used for pregnancy). On 16-MAR-2012, an ultrasound was performed and showed 14 weeks 6 days and the patient was diagnosed to have partial placenta previa. According to ultrasound, estimated delivery date would be 08-SEP-2012. Follow up information had been received from a pediatrician for GARDASIL, a Pregnancy Registry product, reporting that the 23 year old female patient with no concurrent medical conditions, on 08-SEP-2012, 40 weeks from the last menstrual period (LMP), delivered a male infant. The infant's APGAR scores were 8 at one minute and 9 at five minutes. Upon delivery, the infant was noted to be a normal, healthy newborn, with no congenital anomalies and no other complications or abnormalities. It was reported that there were no complications during pregnancy, no complication during delivery, no infections or illness during pregnancy and that on 23-APR-2012 and 14-AUG-2012, an ultrasound was performed which was normal. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Nasal congestion, Nasopharyngitis, Photopsia, Visual impairment
Clinical narrative: Has receive Flu vaccine for 10 years with no problems. 24 hours after vaccination vision affected. Seeing sparks to the left, flashing lights, floaters on left eye. Saw eye doctor on 10/17 and diagnosed with post-vitreous detachment on left eye. Optic nerve fine at this point. On 2nd day after vaccination experiencing cold symptoms including stuffy nose, hoarseness, no scratchy throat yet. Took some cough drops.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Vitreous detachment, Vitreous floaters
Clinical narrative: Has receive Flu vaccine for 10 years with no problems. 24 hours after vaccination vision affected. Seeing sparks to the left, flashing lights, floaters on left eye. Saw eye doctor on 10/17 and diagnosed with post-vitreous detachment on left eye. Optic nerve fine at this point. On 2nd day after vaccination experiencing cold symptoms including stuffy nose, hoarseness, no scratchy throat yet. Took some cough drops.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 24-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 79 years old male patient. The patient was vaccinated subcutaneously on left arm with a dose of 0.7 ml expired ZOSTAVAX (lot # 670617/0618AA; Expire date: 26-JUL-2012) on 09-OCT-2012. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an unknown number of patients. The patients were vaccinated subcutaneously with ZOSTAVAX (dose, lot# not reported) that was improperly stored in the pharmacy for an unknown period of time. The pharmacist was unable to provide the identities or exact number of patients at the time of report. No adverse effects reported. Additional information is not available.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with PNEUMOVAX 23 (lot number 669776/0614AA; expired date 27-SEP-2012) (0.5 ml, intramuscular on unknown injection site) on 14-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 14-OCT-2012 the patient was administered an expired dose of PNEUMOVAX 23 expired date 27-SEP-2012. No adverse effect reported. The outcome was unknown. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of fever in a 44-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 11 July 2012 the subject received a dose of BOOSTRIX (.5 ml, unknown route). On 11 or 12 July 2012, less than one day after vaccination with BOOSTRIX the subject experienced fever and chills. In July 2012, the events were resolved within 3 days. The pharmacist reported two subjects were vaccinated on the same day with same lots of BOOSTRIX at the same pharmacy complained of fever and chills with onset within 1 day of vaccination and resolution within 3 days. See case A0987453A for details regarding the other subject. On 08 August 2012, updated lot number information was received from a safety review. The lot number was reported as A152B078AA from the reporter; however, based on safety lot number review, the lot was updated to AC52B078AA.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of fever in a 62-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included arthritis, back pain and high blood pressure. Concurrent medications included TRAMADOL, Atenolol, Cyclobenzaprine and HCTZ. On 4 June 2012 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left deltoid). In June 2012, less than one week after vaccination with BOOSTRIX, the subject experienced fever, chills nausea erythema, swelling and pain. The subject was not willing to take any other medications to manage the "side effects". At the time of reporting the outcome of the events was unspecified.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of fever in a 62-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included arthritis, back pain and high blood pressure. Concurrent medications included TRAMADOL, Atenolol, Cyclobenzaprine and HCTZ. On 4 June 2012 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left deltoid). In June 2012, less than one week after vaccination with BOOSTRIX, the subject experienced fever, chills nausea erythema, swelling and pain. The subject was not willing to take any other medications to manage the "side effects". At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Eating disorder, Fatigue, Lethargy, Pallor
Clinical narrative: Initial information received from another manufacturer (Reference number: 1-398530441) on 09 August 2012. The information was originally provided to the other manufacturer by a health care professional. A female patient born on 30 July 1998, whose concomitant medications and medical history were not reported, had received MENACTRA (Lot number, route and anatomical site of vaccination were not reported) on an unspecified date. On an unspecified date, the patient was dizzy, lethargic appeared ash grey, had eating disorder and was tired. Corrective treatment and outcome of the events dizzy, lethargic appeared ash grey, eating disorder and tired was not reported. List of documents held by sender none.
Sex: F
Vaccine: TDAP
Symptoms: Foetal exposure during pregnancy, Low birth weight baby, Premature baby
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of low birth weight in a neonate female subject who was exposed to BOOSTRIX (GlaxoSmithKline) received by the subject's mother while pregnant. On 7 April 2011 the mother of the subject received unspecified dose of BOOSTRIX at 0.5 ml in the left arm. The mother's estimated date of delivery was September 2011.  The baby experienced maternal vaccine exposure. It was reported that the female neonate subject was delivered on 24 August 2011, at 37 weeks gestation via normal vaginal delivery. The neonate weighed 4 lbs and 9.1 ounces at birth, with a length of 16.75 inches and a head circumference of 16 inches. No defects were noted in the neonate at birth; however, low birth weight was noted. At the time of reporting the outcome of the event was unspecified.
Age: 54.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of swelling injection site in a 54-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included a 1st dose of TWINRIX (GlaxoSmithKline) given on 20 July 2012. Concurrent medications included Multivitamin. On 20 July 2012 at 10:30 the subject received a dose of BOOSTRIX at 0.5 ml in the right arm. On 20 July 2012 (in the PM), less than one day after vaccination with BOOSTRIX, the subject experienced a large, red, swelling of the right arm (swelling injection site and injection site redness). At the time of reporting the events were improved. The pharmacist considered the events were probably related to vaccination with BOOSTRIX. It was noted by the reporter that the subject might seek medical treatment if the events did not clear up. The dose of TWINRIX administered was not considered to be suspect as it was administered into a different, unspecified site. It was reported that the subject had not had a BOOSTRIX vaccination since childhood.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Fatigue, Pain in extremity, Somnolence
Clinical narrative: This case was reported by a pharmacist (father of the subject) and described the occurrence of arm pain in a 17-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included MENACTRA (Sanofi Pasteur MSD) given on 23 July 2012. There were no concurrent medications. On 23 July 2012 at 15:00 the subject received a booster dose of BOOSTRIX in the left arm. On 23 July 2012, less than one day after vaccination with BOOSTRIX, the subject experienced arm pain. On the afternoon of the following day, 24 July 2012, the subject experienced weakness, tiredness and sleepiness. At the time of reporting the event of arm pain was worse. The remaining events were unresolved. The reporter indicated that he advised his son to take MOTRIN to help his symptoms.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Convulsion, Impaired work ability
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 57-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included asthma, chronic obstructive pulmonary disease, gastroesophageal reflux disease and hyperlipidemia. Concurrent medications included PREVACID, LIPITOR and SPIRIVA. On 16 July 2012 at 16:00 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, right arm). On 19 July 2012 at 10:00, 3 days after vaccination with BOOSTRIX, the subject experienced seizure. This case was assessed as medically serious by GSK. The subject, who was a truck driver, went to the emergency room on 19 July 2012 due to having a seizure. He had never had a seizure before and medically, the only difference was the vaccination. At the time of reporting, he had not had another seizure. He was seen by a neurologist on 30 July 2012 and was awaiting results. The outcome date was reported as 19 July 2012, however, the outcome was reported as unknown. Follow-up information was received on 28 August 2012 via healthcare professional who reported the subject had a seizure on 19 July 2012. The subject was reported to be "unable to drive subject is a truck driver due to reporting to DMV (department of motor vehicles)". The reporting healthcare professional considered the seizure to jeopardize the subject or required intervention. The healthcare professional attributed the seizure to "per neurology report, subject slept four hours before drive for work". The subject was advised not to received BOOSTRIX in the future. Neurology reports still pending. At the time of the report the outcome was unknown.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Extensive swelling of vaccinated limb, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in a 27-year-old female subject who was vaccinated with Tdap (manufacturer unspecified). The subject's medical history included delivery of baby on 20 July 2012. Concurrent medications included Pain medications. On an unspecified day in July 2012, on or after 20 July 2012, the subject received unspecified dose of Tdap (details unknown, left arm). On an unspecified day in July 2012, less than one week after vaccination with Tdap, the subject experienced extensive swelling of vaccinated limb. The subject reported that she experienced "large area of swelling at injection site" to her doctor's office on 24 July 2012. The subject received the vaccination in the hospital sometime after the birth of her baby. She delivered on 20 July 2012. The exact vaccination date was unknown. At the time of reporting the outcome of the event was unspecified.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Chest discomfort, Pain in extremity
Clinical narrative: This case was reported by a physician and described the occurrence of chest tightness in a 28-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 11 June 2012 the subject received "1st booster dose" of BOOSTRIX (unknown, left arm). On 11 June 2012, less than one day after vaccination with BOOSTRIX, the subject experienced chest tightness and arm pain. At the time of reporting the arm pain resolved on an unspecified date and the outcome of the chest tightness was unspecified. At the time of the report no additional information was available.
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of flu-like symptoms in an adult female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 27 June 2012 the subject received a dose of BOOSTRIX (details unknown). On 27 June 2012, less than one day after vaccination with BOOSTRIX, the subject experienced flu-like symptoms. The subject was told by her urgent care that the "tetanus-only vaccine" (not a combination product) administered to her was a GlaxoSmithKline (GSK) product. The subject was not given the name of the product and she planned to call the urgent care back to get further details. The subject declined to provide any further information. GSK does not make a tetanus-only product so the report was entered as BOOSTRIX since the subject stated it was a GSK product. At the time of reporting the event was unresolved.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of sore arm in a 31-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (manufacturer unspecified) given in 2011 following the the birth of a child. There were no concurrent medications. On 13 July 2012 the subject received a dose of BOOSTRIX in the left deltoid at the advice of her physician following, cutting her foot on a rain downspout. The subject experienced a sore arm on 13 July 2012 following BOOSTRIX administration. The subject also experience extra dose administered as she also received a Tdap vaccine following the birth of a child in 2011. At the time of reporting the event of arm soreness was improved. The subject noted that her arm was more sore than other injections she received.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of fever in a 22-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 11 July 2012 the subject received a dose of BOOSTRIX (.5 ml, unknown route). On 11 or 12 July 2012, less than one day after vaccination with BOOSTRIX, the subject experienced fever and chills. In July 2012, the events were resolved within 3 days. The pharmacist reported two subjects were vaccinated on the same day with same lots of BOOSTRIX at the same pharmacy complained of fever and chills with onset within 1 day of vaccination and resolution within 3 days. See case A098745A for details regarding the other subject. On 08 August 2012, updated lot number information was received from a safety review. The lot number was reported as A152B078AA from the reporter; however, based on safety lot number review, the lot was updated to AC52B078AA.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of rash on hands and feet in a male subject aged between 20 and 29 years old who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 7 December 2011 the subject received a dose of BOOSTRIX (unknown route). In December 2011, less than one week after vaccination with BOOSTRIX, the subject experienced rash on hands and feet. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was unrelated to vaccination with BOOSTRIX. Follow-up information was received on 04 January 2012 via nurse who is the immunization provider. The 26-year-old male subject previously received DTaP and Td form; no adverse events followed previous vaccinations. On 14 December 2011, seven days after the initial dose of BOOSTRIX the subject experienced the rash on hands and feet that resolved on 19 December 2012. The reporting nurse considered the rash on hands and feet unrelated to vaccination with BOOSTRIX. At the time of the report no additional information was provided.
Age: 67.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Limb discomfort, Muscular weakness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm discomfort in a 67-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included PNEUMOVAX 23 (Merck) given on 7 December 2011. Concurrent medications included aspirin and multivitamins. On 7 December 2011 at 15:30 the subject received a dose of BOOSTRIX at 0.5 ml in the right deltoid. On 7 December 2011, less than one day after vaccination with BOOSTRIX, the subject experienced arm discomfort and arm weakness. At the time of reporting the events were unresolved. It was reported that the subject was due for a doctor's visit soon and an assessment would be made at that time.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 13-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARR #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 673029/0616AE, expiration date not listed, dose not reported) on 20-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #:1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of raised area injection site in a subject of unspecified age (18 to 60 years of age) and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). In January 2012 (either the 17th or the 18th) the subject inadvertently received a dose of BOOSTRIX intradermally. This was wrong vaccine administered and inappropriate route of vaccination. The subject should have received a ppd skin test. BOOSTRIX should be administered intramuscularly when ordered. Within the same week of receiving BOOSTRIX (on or prior to 20 January 2012) the subject experienced redness, raised, pain and itching at the site of injection. The outcome of the events was unknown at the time of reporting. It was reported BOOSTRIX was inadvertently administered intradermally to 7 subjects instead of the ppd skin test. It was noted that the subjects were roughly between the ages of 18 to 60 years. Two of the subjects were males and the rest were females. One subject reported redness, raised, pain and itching at the site of injection (this case A0962818A). Three subjects reported no adverse event and no additional information was known regarding the other 3 subjects. Additional linked cases include A0962809A, A0962813A, A0962814A, A0962815A, A0962816A and A0962817A. Follow-up information was received for this case on 08 February 2012. It was reported that the subject was a 21 year old female. Injection site reaction including redness, raised area, pain and itching at the site of injection with onset of 17 January 2012 were noted. Per previous reported information vaccination with BOOSTRIX occurred on the 17th or 18th of January 2012. Given the onset of events was 17 January 2012, administration of BOOSTRIX should have occurred on the same day of event onset, 17 January 2012. Resolution from a single dose vial inadvertently and intradermally instead of tuberculin purified protein derivative. No significant medical history was reported. Seasonal contraceptive an ibuprofen were taken concurrently.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of raised area injection site in a subject of unspecified age (18 to 60 years of age) and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). In January 2012 (either the 17th or the 18th) the subject inadvertently received a dose of BOOSTRIX intradermally. This was wrong vaccine administered and inappropriate route of vaccination. The subject should have received a ppd skin test. BOOSTRIX should be administered intramuscularly when ordered. Within the same week of receiving BOOSTRIX (on or prior to 20 January 2012) the subject experienced redness, raised, pain and itching at the site of injection. The outcome of the events was unknown at the time of reporting. It was reported BOOSTRIX was inadvertently administered intradermally to 7 subjects instead of the ppd skin test. It was noted that the subjects were roughly between the ages of 18 to 60 years. Two of the subjects were males and the rest were females. One subject reported redness, raised, pain and itching at the site of injection (this case A0962818A). Three subjects reported no adverse event and no additional information was known regarding the other 3 subjects. Additional linked cases include A0962809A, A0962813A, A0962814A, A0962815A, A0962816A and A0962817A. Follow-up information was received for this case on 08 February 2012. It was reported that the subject was a 21 year old female. Injection site reaction including redness, raised area, pain and itching at the site of injection with onset of 17 January 2012 were noted. Per previous reported information vaccination with BOOSTRIX occurred on the 17th or 18th of January 2012. Given the onset of events was 17 January 2012, administration of BOOSTRIX should have occurred on the same day of event onset, 17 January 2012. Resolution from a single dose vial inadvertently and intradermally instead of tuberculin purified protein derivative. No significant medical history was reported. Seasonal contraceptive an ibuprofen were taken concurrently.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 27-APR-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2012, dose not reported) on 06-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS#: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006066, 1210USA006067, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure
Clinical narrative: This spontaneous report was received from a pharmacist concerning a female patient of unknown age. On 13-SEP-2012, the pharmacist was injecting a dose of 0.65 milliliter ZOSTAVAX (lot number unspecified) subcutaneously to a patient in the pharmacy. While injecting, the ZOSTAVAX dripped down her arm. No concomitant medications were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a office manager(healthcare prof-other) refers to a patient of unknown age. The patient, on 11-OCT-2012, was subcutaneously vaccinated with 0.65 ml of ZOSTAVAX (lot # 671018/0748AA) that expired 18-AUG-2012. The patient was not experiencing any known symptoms. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 673029/0616AE, expiration date not listed, dose not reported) on 22-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was intended to receive vaccinated ZOSTAVAX was inadvertently administered with 0.5 ml of VARIVAX (merck) (Lot# unspecified) on 11-OCT-2012. No adverse effects reported. The outcome was unknown unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a female consumer, of unknown age, concerning herself. On 05-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not reported) (Lot # and expiration date were not reported). On 08-AUG-2012, the patient arm was sore and warm to the touch at the injection site. Patient stated that she was going to have a Dr. Appointment on 10-OCT-2012, and she would bring it up then. Patient also reported that she was fine other than the symptoms that have been mentioned. At the time of the report, the patient outcome was unknown. The relatedness for her arm was sore at the injection site and her arm was warm to the touch at the injection site was unknown for ZOSTAVAX. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a consumer refers to herself a 63 years old female patient. On 02-OCT-2012, the patient was vaccinated subcutaneously with, 0.65 ml ZOSTAVAX (lot not reported). Concomitant medications included: CRESTOR. The consumer stated that on 02-OCT-2012 the patient was vaccinated with ZOSTAVAX and she had an adverse event (AE) after getting the vaccination. On 03-OCT-2012, she noticed a red spot larger than a quarter at the reaction site, it did not itch and had starting going away as of 04-OCT-2012. No laboratory tests were performed. The patient did not receive treatment for the adverse events. The patient did not seek medical attention. The outcome of red spot larger than a quarter at the reaction site was reported as recovering. The relatedness for red spot larger than a quarter at the reaction site was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 673029/0616AE, expiration date and dose not reported) on 16-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Rash generalised, Rash papular
Clinical narrative: This spontaneous report as received from a physician refers to a 69 years old female patient with sulfa allergy, CIPRO allergy and fibromyalgia. The patient was vaccinated with ZOSTAVAX on 09-OCT-2012 or 10-OCT-2012. Lot# and route were unspecified. No other co-suspects were reported. In October 2012, the patient experienced papular vesicular rash scattered over her body after receiving ZOSTAVAX. Specimen of vesical was sent to laboratory for evaluation. No result was provided at reporting time. The outcome of patient was reported as not recovered/not resolved. The patient visited office to seek medical attention. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 673029/0616AE, expiration date not listed, dose not reported) on 13-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 673029/0616AE, expiration date not noted, dose not reported) on 16-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 6726091/1733AA, expiration date 04-FEB-2013, dose not reported) on 10-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 673029/0616AE, expiration date not listed, dose not reported) on 15-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Dyspnoea
Clinical narrative: This case was reported by a healthcare professional (subject's mother), via a GSK representative, and described the occurrence of shortness of breath in a 28-year-old female subject who was vaccinated with DTPA (manufacturer unspecified). Concurrent medical conditions included post-partum. On 18 September 2011 the subject received booster dose of DTPA (detail unknown). On 18 September 2011, less than one day after vaccination with DTPA, the subject experienced shortness of breath. At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with DTPA.
Sex: U
Vaccine: TDAP
Symptoms: Injection site joint pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (details unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced injection site pain "described as arthritic". At the time of reporting the outcome of the event was unspecified.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Influenza like illness, Malaise, Nausea, Pain
Clinical narrative: This case was reported by a healthcare professional (occupational health nurse) and described the occurrence of flu like symptoms in a 38-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 23 March 2012 at 12:00 the subject received a dose of BOOSTRIX at 0.5 ml in the left arm. On 23 March 2012, 6 to 8 hours after vaccination with BOOSTRIX, the subject experienced flu like symptoms, body pain,  nausea and low grade fever. The subject was treated with TYLENOL. The events were reported to be resolved as of 25 March 2012; however, the subject reported still having malaise, tiredness and a sleepy feeling the day prior to reporting. Outcome of these events was not reported. It was noted that the subject returned to work. The healthcare professional considered the events of flu like symptoms, body pain, nausea and low grade fever were probably related to vaccination with BOOSTRIX. Attribution of malaise, tiredness and sleepy feeling to BOOSTRIX administration was not known.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Somnolence
Clinical narrative: This case was reported by a healthcare professional (occupational health nurse) and described the occurrence of flu like symptoms in a 38-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 23 March 2012 at 12:00 the subject received a dose of BOOSTRIX at 0.5 ml in the left arm. On 23 March 2012, 6 to 8 hours after vaccination with BOOSTRIX, the subject experienced flu like symptoms, body pain,  nausea and low grade fever. The subject was treated with TYLENOL. The events were reported to be resolved as of 25 March 2012; however, the subject reported still having malaise, tiredness and a sleepy feeling the day prior to reporting. Outcome of these events was not reported. It was noted that the subject returned to work. The healthcare professional considered the events of flu like symptoms, body pain, nausea and low grade fever were probably related to vaccination with BOOSTRIX. Attribution of malaise, tiredness and sleepy feeling to BOOSTRIX administration was not known.
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Sensation of heaviness, Urticaria
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of hive-like rash in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX. One day after vaccination with BOOSTRIX, the subject experienced hive-like rash on her forearms, back and legs that cleared (resolved) with BENADRYL treatment. It was noted that the subject called the reporter last week and reported her legs feeling heavy, welts on her body and tingling of her hands. At the time of reporting the outcome of these events was unspecified. The nurse practitioner stated that the subject reported that she went to see her primary care physician and the physician told the subject that this was a delayed reaction to the tetanus component of the BOOSTRIX vaccine; however, the nurse practitioner stated that they were still trying to pinpoint what had caused these symptoms in the subject (possible relationship to BOOSTRIX vaccine).
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 31-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included iodine allergy and latex allergy. Concurrent medications included CLARITIN and an unspecified nasal decongestant. Historic vaccination included tetanus vaccine (non-gsk, manufacturer unknown) given in 1988. The subject (a school teacher) received a human bite at school and on 20 March 2012 at 15:30 the subject received a dose of BOOSTRIX at 0.5 ml in the right arm. In March 2012 (on or prior to 27 March 2012), less than one week after vaccination with BOOSTRIX, the subject experienced swelling injection site, nodule injection site, injection site redness, injection site soreness (and pain) and injection site warmth. The reporter stated that the physician told the subject that she should take ibuprofen for the swelling and the pain, but no other treatments were suggested. At the time of reporting the events were unresolved (subject still "having problems" from the injection).
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspepsia, Fatigue, Malaise, Nausea, Vomiting
Clinical narrative: This case was reported by a pharmacist and described the occurrence of feeling unwell in a 81-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included Trazodone, Gabapentin and Omeprazole. On 10 April 2012 (noonish to 14:00) the subject received a dose of BOOSTRIX at 0.5 ml in the left arm. In April 2012, less than one week after vaccination with BOOSTRIX (on or before 12 April 2012), the subject experienced feeling unwell, nausea, heartburn, vomiting (x1) and tiredness. At the time of reporting the events were improved, but not resolved. It was reported that the subject was attempting to make an appointment with her physician regarding these symptoms. Follow-up information was received on 08 May 2012 via pharmacist. The subject was seen by a physician, who felt the reaction was no due to immunization. The subject was reported to have improved, no more nausea. At the time of the report no other details were provided.