chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site nodule
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nodule injection in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included pulmonary disease, endocarditis, intestinal perforation, prematurity at 25 weeks gestation and retinopathy. Concurrent vaccination included pneumococcal vaccines (non-GSK); Wyeth Labs; unknown; unknown given on 29 June 2013. Concurrent medications included Ampicillin, Caffeine, LASIX, GENTAMYCIN, PRED FORTE and Parenteral fat emulsion (TPN lipids). On 29 June 2013 at 12:54 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, left thigh). On 30 June 2013, 1 day after vaccination with PEDIARIX, the subject experienced nodule injection site. The nodule was described as large. The subject was in the neonatal intensive care unit at the time of vaccination. The pharmacist reported that the immunization series not discontinued or delayed. On 11 July 2013, 12 days after onset, the event was resolved. The pharmacist reported 4 other cases. See cases A1033993A, A1033994A, a1033995A, and A1033997A for details on the other cases. Follow up received on 6 August 2013. The lot number was reported as AC218406CA from the reporter; however, based on safety lot number review, the lot number was updated to AC21B406CA.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: BUMPS ON LEGS, RASH LIKE THE ITCHING, HIVE AFTER SCRATCHING. IMMUNIZATIONS WERE GIVE IN UPPER LEFT AND RIGHT ARMS LASTED UNTIL 1 AM WHEN MOTHER RETURNED FROM PHARMACY TO BUY BENADRY. CHILD ASLEEP NO TREATMENT, NO RESPIRATORY DISTRESS.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt reported today pain in arm causing discomfort upon use that first occurred after vaccination and has not improved since.  Patient states it is very uncomfortable to use arm.  Condition has not improved at time of reporting.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Emotional distress, Injection site swelling, Injection site warmth
Clinical narrative: Uncontrollable crying, unconsolable, swollen leg, and very warm to the touch.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Crying, Injection site erythema, Irritability, Urticaria
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of unusual crying in a 9-week-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). The subject's medical history included prematurity. Concurrent medical conditions included cow's milk intolerance, rectal bleeding and reflux (nos). Concurrent vaccination included haemophilius influenza type b;manufacturer unspecified;unknown;unknown;unknown given on 26 March 2013; pneumococcal (non-gsk) ;non-GSK manufacturer;unknown;unknown given on 26 March 2013; rotovirus (non-gsk) ;non-GSK manufacturer;unknown;unknown given on 26 March 2013. Concurrent medications included PRILOSEC. On 26 March 2013 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, unknown thigh). On 26 March 2013, "within 1 hour" after vaccination with PEDIARIX, the subject experienced unusual crying. The "unusual crying" lasted for more than 3 hours and was "on and off for 2 to 3 days." At the time of reporting, the nurse practitioner reported that the adverse event "may lead to discontinuation of the pertussis-containing vaccines for this" subject. On 29 March 2013, the event was resolved. Follow up was received from reporter on 10 June 2013. The nurse practitioner reported that the adverse event resolved after 5 days on 31 March 2013. which was previously reported as resolved after 3 days on 29 March 2013. The reporter did not consider this case to be serious. The healthcare professional documented that the event was not associated to a congenital anomaly or birth defect and was did not jeopardize the subject or require intervention. The healthcare professional stated that the subject experienced "red area at vaccine site/ leg only. 'Normal per mom' not extreme ." The healthcare professional also documented that the subject was "not consolable with crying after vaccination. Then after that was fussy on and off [fussiness] and not herself [not well being] for at least 5 days." By 1 April 2013, the subject was normal. The healthcare professional documented that on 3 May 2013, 38 days after vaccination with PEDIARIX, the subject experienced "similar event" of unconsolable crying that lasted for 2 hours. The subject was seen on 4 May 2013 and had a viral rash or urticarial rash per the reporter. The reporter also stated that the "following day asymptomatic." On 20 May 2013, they subject received ROTATEQ and experienced fussiness for "20 min then okay." On 31 May 2013 the subject was given PREVNAR and had no reactions. The reporter stated that DTAP series has been interrupted and documented that they are "withholding DTAP vaccine until seen by neurologist per the mom request." The reporter also stated that they are "giving vaccines one at a time."
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Viral rash
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of unusual crying in a 9-week-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). The subject's medical history included prematurity. Concurrent medical conditions included cow's milk intolerance, rectal bleeding and reflux (nos). Concurrent vaccination included haemophilius influenza type b;manufacturer unspecified;unknown;unknown;unknown given on 26 March 2013; pneumococcal (non-gsk) ;non-GSK manufacturer;unknown;unknown given on 26 March 2013; rotovirus (non-gsk) ;non-GSK manufacturer;unknown;unknown given on 26 March 2013. Concurrent medications included PRILOSEC. On 26 March 2013 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, unknown thigh). On 26 March 2013, "within 1 hour" after vaccination with PEDIARIX, the subject experienced unusual crying. The "unusual crying" lasted for more than 3 hours and was "on and off for 2 to 3 days." At the time of reporting, the nurse practitioner reported that the adverse event "may lead to discontinuation of the pertussis-containing vaccines for this" subject. On 29 March 2013, the event was resolved. Follow up was received from reporter on 10 June 2013. The nurse practitioner reported that the adverse event resolved after 5 days on 31 March 2013. which was previously reported as resolved after 3 days on 29 March 2013. The reporter did not consider this case to be serious. The healthcare professional documented that the event was not associated to a congenital anomaly or birth defect and was did not jeopardize the subject or require intervention. The healthcare professional stated that the subject experienced "red area at vaccine site/ leg only. 'Normal per mom' not extreme ." The healthcare professional also documented that the subject was "not consolable with crying after vaccination. Then after that was fussy on and off [fussiness] and not herself [not well being] for at least 5 days." By 1 April 2013, the subject was normal. The healthcare professional documented that on 3 May 2013, 38 days after vaccination with PEDIARIX, the subject experienced "similar event" of unconsolable crying that lasted for 2 hours. The subject was seen on 4 May 2013 and had a viral rash or urticarial rash per the reporter. The reporter also stated that the "following day asymptomatic." On 20 May 2013, they subject received ROTATEQ and experienced fussiness for "20 min then okay." On 31 May 2013 the subject was given PREVNAR and had no reactions. The reporter stated that DTAP series has been interrupted and documented that they are "withholding DTAP vaccine until seen by neurologist per the mom request." The reporter also stated that they are "giving vaccines one at a time."
Age: 1.6
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of swelling injection site in a 31-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). On 3 December 2012 at 15:45 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, left thigh). On 3 December 2012, immediately after vaccination with PEDIARIX, the subject experienced swelling injection site ("swollen leg") and redness of leg of injection site ("red leg"). The nurse reported that the "parents complained of a left swollen leg." At the time of reporting the outcome of the events were unknown. The reporter stated that no additional information was known at this time. The nurse reported two subjects with adverse events. See case A1004928A for details on the other case. Follow up received from healthcare professional (medical assistant) on 16 January, 2013. The healthcare professional documented that the subject was 19 months old at the time of vaccination with PEDIARIX. On 3 December 2012, all events had resolved. The healthcare professional did not consider the events serious. The subject had not experienced adverse events following previous vaccinations. The medical assistant documented that this case had been reported to a regulatory agency.
Age: 1.54
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extensive swelling of vaccinated limb, Immediate post-injection reaction, Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of extensive swelling of vaccinated limb in a 18-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). On 19 November 2012 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, left thigh). On 19 November 2012, immediately after vaccination with PEDIARIX, the subject experienced extensive swelling of vaccinated limb ("left swollen leg 3 to 4 inches"), redness of leg at injection site, warmness to touch at injection site and fluid collection at injection site ("looks like fluid inside"). The nurse stated that "the parents complained of a left swollen leg (3-4 inches), it was warm to the touch and looked like fluid inside." At the time of reporting the outcome of the events were unspecified. The nurse stated that there was no additional information known at the time of reporting. The nurse reported two subjects with adverse events. See case A1004599A for details on the other case. Follow up received from healthcare professional on 2 January 2013. The healthcare professional clarified the onset of the adverse events. On 20 November 2012, one day after vaccination with PEDIARIX, the subject experienced extensive swelling of vaccinated limb, redness of leg at injection site, warmness to touch at injection site and fluid collection at injection site. The adverse events resolved on the same date of 20 November 2012. The healthcare professional documented that she did not consider this event to be serious. There was no biopsy performed. At the time of reporting, the subject has not received additional doses of PEDIARIX since the adverse event. The reporter documented that the subject had received PEDIARIX in the past; however, she had previously reported that this was the first dose of PEDIARIX. The immunization series was not delayed or discontinued. It was unknown if the subject experienced symptoms with subsequent administration. The subject has not experienced any adverse events following previous vaccinations.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Local swelling
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of swollen leg in a 2-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). On 5 February 2013 the subject received 1st dose of PEDIARIX (unknown route, unknown thigh). On 5 February 2013, less than one day after vaccination with PEDIARIX, the subject experienced swollen leg. The representative was not sure which leg experienced the swelling and which leg received the vaccination. The representative was also not sure about the date of PEDIARIX administration and onset of the swollen leg. At the time of reporting the outcome of the event was unspecified. The physician considered the event was probably related to vaccination with PEDIARIX.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Hepatitis B surface antibody negative, Incorrect dose administered
Clinical narrative: This case was reported by a physician's office manager and described the occurrence of hepatitis b surface antibody negative in a female subject of unspecified age who was vaccinated with DTPa-HBV-IPV (manufacturer unspecified), ENGERIX B. In 1995 the subject received 1st dose, 2nd dose and 3rd dose of DTPa-HBV-IPV (unknown details) on a 2, 4, and 6 month schedule. In February 2013 the subject received 4th dose of ENGERIX B (unknown details) and experienced extra dose administered. The subject had received a completed hepatitis B vaccination series in 1995. In February 2013, 18 years after vaccination with DTPa-HBV-IPV, the subject experienced hepatitis b surface antibody negative. "Titers for anti-HBsAg [antibody to the hepatitis B surface antigen] are now less than 0.1 mIU/mL." The physician reported another case with similar events. See case A1011474A for details on the other case.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in an unknown number of subjects of unspecified age who were vaccinated with DTPA-HIBV-IPV (manufacturer unspecified). On an unknown date(s), subjects received 1st dose, 2nd dose and 3rd dose of DTPA-HBV-IPV (unknown details). On an unknown date, at an unknown time after vaccination with DTPA-HBV-IPV, the subjects experienced not responding to therapy. "Titers for anti-HBsAg [antibody to the hepatitis B surface antigen] are now less than 0.1 mIU/mL." The physician reported that "they have seen this in a couple other children who are now grown." The physician reported another case with similar events. See case A1011287A for details on the other case.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Hepatitis B DNA assay negative, Hepatitis B surface antigen positive, Polymerase chain reaction
Clinical narrative: This case was reported by a pharmacist via Merck and described the occurrence of hepatitis B surface antigen positive in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline; unknown; unknown given on an unspecified. On 23 March 2013 the subject received 2nd dose of PEDIARIX (unknown). On an unspecified date in March 2013, at an unspecified time after vaccination with PEDIARIX, the subject experienced hepatitis B surface antigen positive. The infant subject was vaccinated with her 2nd dose of PEDIARIX on 23 March 2013 in the right thigh. A titer was drawn in March 2013, (the day of this report to Merck, specific date not specified) and the lab shows that the subject is hepatitis B surface antigen positive. At the time of reporting the outcome of the hepatitis B surface antigen positive was unspecified. Follow-up information was received on 24 April 2013 via healthcare professional who clarified concurrent vaccination PEDIARIX was administered intramuscularly in the left thigh given on 23 January 2013. On 23 March 2013 the subject received 2nd dose of PEDIARIX (.5 ml, intramuscular, right thigh). The healthcare professional reported that on 27 March 2013, 4 days after vaccination with PEDIARIX, the subject experienced hepatitis B surface antigen positive. The subject had a titer was drawn on 27 March 2013, on 28 March 2013 the Hepatitis B virus (HBV) DNA quantity polymerase chain reaction (PCR) was not detected. The reporting healthcare professional attributed the hepatitis B surface antigen positive to a false positive four days post vaccination. The immunization series with PEDIARIX was not delayed or discontinued. On 28 March 2013, the event was resolved.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of crying in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included Hib (non-gsk); non-GSK manufacturer; unknown; unknown given on 01 October 2013; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 1 October 2013; rotavirus vaccine (non-gsk); non-GSK manufacturer; unknown given on 1 October 2013. On 1 October 2013 the subject received a dose of PEDIARIX (unknown details). On 2 October 2013, 1 day after vaccination with PEDIARIX, the subject experienced crying, irritability and fever. The nurse reported that the subject was "crying and irritable with a 104 degree fever." Relevant test results included body temperature taken on 2 October 2013 with results of 104 degree fever. At the time of reporting the outcome of the events were unspecified. The nurse documented 2 other cases with PEDIARIX. See cases A1044387A and A1044385A for details on the other cases.
Age: 0.62
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash generalised
Clinical narrative: This case was reported by a pharmacist and described the occurrence of rash spots in a 7-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR (non-gsk) and Hib (non-gsk). On 17 April 2013 the subject received 3rd dose of PEDIARIX (unknown, left thigh), 3rd dose of PREVNAR (unknown), 3rd dose of Hib (Non-GSK) (unknown). On 20 April 2013, 3 days after vaccination with Hib (Non-GSK), PEDIARIX and PREVNAR, the subject experienced rash-like spots. The subject developed rash-like spots on her face three days after receiving vaccinations. The subject was evaluated at the clinic on 01 May2013 and the spots were now all over her body. The physician prescribed BENADRYL to treat the subject. It was reported that there were no changes in the subject's food or laundry detergent. The immunization series with PEDIARIX was not discontinued or delayed. At the time of reporting the event was unresolved. The pharmacist considered the event was possibly related to vaccination with PEDIARIX, PREVNAR and Hib (Non-GSK). Follow up information received from the pharmacist on 22 July 2013. The pharmacist reported that no action was taken with PEDIARIX, PREVNAR and Hib (Non-GSK). The pharmacist confirmed that PEDIARIX, PREVNAR, and Hib were all suspect and the event started on 20 April 2013. At the time of the follow up report, the outcome of the event was unknown.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a healthcare professional (nurse) via Merck and described the occurrence of fever in an unspecified number of subjects of unspecified ages and gender who were vaccinated with PEDIARIX (GlaxoSmithKline), DTPA. On an unspecified dates the subjects received unspecified doses of PEDIARIX (unknown) or unspecified doses of DTPA (unknown). At unspecified times after vaccination with DTPA or PEDIARIX, the subjects experienced fever. A nurse mentioned that some subject developed a fever after receiving PEDIARIX and TDAP vaccines. At the time of the report no other information was provided. At the time of reporting the outcome of the fever was unspecified. The nurse's contact information was not provided, therefore no additional information could be obtained. PEDIARIX, the subjects experienced fever. A nurse mentioned that some subject develop a fever after receiving PEDIARIX and TDAP vaccines. At the time of the report no other information was provided. At the time of reporting the outcome of the fever was unspecified. The nurse's contact information was not provided, therefore no additional information could be obtained.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Bordetella test positive, Pertussis, Vaccination failure
Clinical narrative: This case was reported by a physician and described the occurrence of bordetella pertussis in a 6-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). On unspecified dates the subject received 1st dose, 2nd dose and 3rd dose of PEDIARIX (unknown). Less than one year after vaccination with PEDIARIX, the subject experienced Bordetella pertussis, Bordetella pertussis test positive and vaccination failure. The physician inquired about storage/ transportation recommendations and reported a subject tested positive for Pertussis after being vaccinated with PEDIARIX. The subject was 6-months old and had just received the 3rd dose of PEDIARIX. At the time of the report no additional information was available. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the Bordetlla pertussis and Bordetella pertussis test positive was unspecified. The physician reported another case of Bordetella pertussis test positive, for that subject please see case A1024573A.
Sex: U
Vaccine: DTAP
Symptoms: Bordetella test positive, Pertussis
Clinical narrative: This case was reported by a physician and described the occurrence of bordetella pertussis in a subject of unspecified age and gender who was vaccinated with PEDIARIX (GlaxoSmithKline), INFANRIX. On an unspecified date the subject received unspecified dose of PEDIARIX (unknown) or an unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX or PEDIARIX, the subject experienced bordetella pertussis and bordetella pertussis test positive. The physician inquired about storage/transportation recommendations and reported a subject tested positive for Pertussis after being vaccinated with INFANRIX or PEDIARIX. The physician did not remember any details of the regarding the subject. At the time of the report no additional information was available. At the time of reporting the outcome of the Bordetella pertussis and Bordetella pertussis test positive was unspecified. The physician reported another case of Bordetella pertussis test positive, for that subject please see case A1024572A.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of fever in an unknown number of subjects of unspecified age and gender who were vaccinated with PEDIARIX (GlaxoSmithKline). On an unspecified date (s) the subject(s) received a dose of PEDIARIX (unknown details). At an unspecified time after vaccination with PEDIARIX, the subject (s) experienced fever. The nurse reported that her office had "received a lot of calls asking about fever after having the PEDIARIX vaccine." The nurse indicated that the office staff was "a little bit concerned about this." At the time of reporting the outcome of the event was unspecified. The nurse reported 2 other cases with PEDIARIX. See cases A1044386A and A1044387A for details on the other cases. Follow up was received from the nurse on 21 October 2013. The nurse reported that this case had been reported to a Regulatory authority; however, the reference number was not provided. The nurse described the occurrence of fever in a 6-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). On 1 October 2013 the subject received a dose of PEDIARIX (0.5ml, unknown details). Concurrent vaccination included haemophilus influenzae type b (non-gsk) ;non-GSK manufacturer;intramuscular;unknown given on 1 October 2013; pneumococcal vaccines (non-gsk) ;non-GSK manufacturer;intramuscular;unknown given on 1 October 2013; rotavirus vaccine (non-gsk) ;non-GSK manufacturer;oral given on 1 October 2013; seasonal; influenza vaccine (non-gsk) ;non-GSK manufacturer;intramuscular;unknown given on 1 October 2013. On 1 October 2013 the subject received 3rd dose of PEDIARIX (.5 ml, unknown details). On 2 October 2013, 1 day after vaccination with PEDIARIX, the subject experienced fever and irritability. The diagnosis was fever. On 5 October 2013, the events were resolved. The nurse identified the suspect product as PEDIARIX. The nurse did not consider the case of as serious.
Age: 10.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Drug administered to patient of inappropriate age, Injection site discomfort
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm discomfort at injection site in a 10-year-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medications included Multivitamins (Daily vitamin). On 19 September 2013 at 15:00 the subject mistakenly received a dose of PEDIARIX (unknown route, unknown deltoid), and experienced inappropriate age at vaccine administration. The subject was older than the indicated age for administration of PEDIARIX. On 20 September 2013, 1 day after vaccination with PEDIARIX, the subject experienced "arm discomfort" (arm discomfort at injection site). The event was reported as a local injection site reaction. At the time of reporting the outcome of the event was unspecified.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Nephrotic syndrome
Clinical narrative: Nephrotic syndrome 04/2010. No live vaccines until cleared by nephrology. H/o RVS 2007.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician, via a GSK representative, and described the occurrence of high fever in an infant male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of PEDIARIX (.5 ml, unknown route and site). On an unspecified date in either August or September 2013, at an unspecified time after vaccination with PEDIARIX, the subject experienced high fever. The physician reported that the subject was taken to the Emergency Room "multiple" times for the high fever. At the time of reporting the event was resolved. The physician considered the event was probably related to vaccination with PEDIARIX. The physician also reported that multiple subjects had reported fever following vaccination with PEDIARIX. See case ID A1042995A for details.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician, via a GSK representative, and described the occurrence of fever in "multiple" subjects of unspecified age and gender who were vaccinated with PEDIARIX (GlaxoSmithKline). On unspecified dates the subjects received unspecified dose of PEDIARIX (.5 ml, unknown route and site). On unspecified dates, at an unspecified time after vaccination with PEDIARIX, the subjects experienced fever. The outcome of the event was unknown. The physician also reported an infant subject who experienced high fever following vaccination with PEDIARIX. See case ID A1042992A for details.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site nodule
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nodule injections site in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included prematurity. Concurrent vaccination included PREVNAR (non-gsk); Wyeth Labs; unknown; unknown given on 15 June 2013. Concurrent medications included Erythromycin ethyl succinate (EES), Multivitamins + iron and Zantac. On 15 June 2013 at 22:45 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, left thigh). Within an unknown number of days after vaccination with PEDIARIX, the subject experienced nodule injections site. The subject was in the neonatal intensive care unit at the time of vaccination. The pharmacist documented that the immunization series was not discontinued or delayed. At the time of reporting the event was resolved. The pharmacist reported 4 other cases. See cases A1033993A, A1033994A, A1033995A, and A1033996A for details on the other cases.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Angiogram abnormal, Colour vision tests normal, Fundoscopy abnormal, Intraocular pressure test normal, Ophthalmological examination
Clinical narrative: This case was reported in a literature article and described the occurrence of multiple evanescent white dot syndrome in a 53-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject's medical history included pterygium excised. Concurrent medical conditions included hepatitis b and c carrier, polysubstance abuse and rehabilitation. Concurrent medications included Buprenorphine and Naloxone. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unknown route, site of injection and batch number). 10 days after vaccination with Influenza vaccine, the subject presented with a complaint of seeing a purple haze in his right eye. Initial examination revealed corrected visual acuity of 20/25 -2 OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE with agranular foveal appearance. Fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with aparacentral scotoma, which improved over time. The subject was diagnosed with multiple evanescent white dot syndrome. this case was assessed as medically serious by GSK. At the 1-month visit, the subject noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Ophthalmological examination abnormal, Pupillary light reflex tests normal, Retinal exudates, Retinal pigment epitheliopathy, Scotoma
Clinical narrative: This case was reported in a literature article and described the occurrence of multiple evanescent white dot syndrome in a 53-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject's medical history included pterygium excised. Concurrent medical conditions included hepatitis b and c carrier, polysubstance abuse and rehabilitation. Concurrent medications included Buprenorphine and Naloxone. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unknown route, site of injection and batch number). 10 days after vaccination with Influenza vaccine, the subject presented with a complaint of seeing a purple haze in his right eye. Initial examination revealed corrected visual acuity of 20/25 -2 OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE with agranular foveal appearance. Fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with aparacentral scotoma, which improved over time. The subject was diagnosed with multiple evanescent white dot syndrome. this case was assessed as medically serious by GSK. At the 1-month visit, the subject noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Vision blurred, Visual acuity reduced, Visual field tests normal, Visual impairment
Clinical narrative: This case was reported in a literature article and described the occurrence of multiple evanescent white dot syndrome in a 53-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject's medical history included pterygium excised. Concurrent medical conditions included hepatitis b and c carrier, polysubstance abuse and rehabilitation. Concurrent medications included Buprenorphine and Naloxone. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unknown route, site of injection and batch number). 10 days after vaccination with Influenza vaccine, the subject presented with a complaint of seeing a purple haze in his right eye. Initial examination revealed corrected visual acuity of 20/25 -2 OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE with agranular foveal appearance. Fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with aparacentral scotoma, which improved over time. The subject was diagnosed with multiple evanescent white dot syndrome. this case was assessed as medically serious by GSK. At the 1-month visit, the subject noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Angiogram abnormal, Angiogram retina abnormal, Colour vision tests normal, Fundoscopy abnormal, Intraocular pressure test normal
Clinical narrative: This case was reported in a literature article and described the occurrence of multiple evanescent white dot syndrome in a 53-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject's medical history included pterygium excised. Concurrent medical conditions included hepatitis b and c carrier, polysubstance abuse and rehabilitation. Concurrent medications included Buprenorphine and Naloxone. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unknown route, site of injection and batch number). 10 days after vaccination with Influenza vaccine, the subject presented with a complaint of seeing a purple haze in his right eye. Initial examination revealed corrected visual acuity of 20/25 -2 OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE with agranular foveal appearance. Fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with aparacentral scotoma, which improved over time. The subject was diagnosed with multiple evanescent white dot syndrome. this case was assessed as medically serious by GSK. At the 1-month visit, the subject noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Pupillary light reflex tests normal, Retinal exudates, Retinal pigment epitheliopathy, Scotoma, Vision blurred
Clinical narrative: This case was reported in a literature article and described the occurrence of multiple evanescent white dot syndrome in a 53-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject's medical history included pterygium excised. Concurrent medical conditions included hepatitis b and c carrier, polysubstance abuse and rehabilitation. Concurrent medications included Buprenorphine and Naloxone. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unknown route, site of injection and batch number). 10 days after vaccination with Influenza vaccine, the subject presented with a complaint of seeing a purple haze in his right eye. Initial examination revealed corrected visual acuity of 20/25 -2 OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE with agranular foveal appearance. Fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with aparacentral scotoma, which improved over time. The subject was diagnosed with multiple evanescent white dot syndrome. this case was assessed as medically serious by GSK. At the 1-month visit, the subject noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Visual acuity tests abnormal, Visual field tests abnormal
Clinical narrative: This case was reported in a literature article and described the occurrence of multiple evanescent white dot syndrome in a 53-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject's medical history included pterygium excised. Concurrent medical conditions included hepatitis b and c carrier, polysubstance abuse and rehabilitation. Concurrent medications included Buprenorphine and Naloxone. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unknown route, site of injection and batch number). 10 days after vaccination with Influenza vaccine, the subject presented with a complaint of seeing a purple haze in his right eye. Initial examination revealed corrected visual acuity of 20/25 -2 OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE with agranular foveal appearance. Fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with aparacentral scotoma, which improved over time. The subject was diagnosed with multiple evanescent white dot syndrome. this case was assessed as medically serious by GSK. At the 1-month visit, the subject noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Angiogram abnormal, Colour vision tests normal, Fundoscopy abnormal, Intraocular pressure test normal, Pupillary light reflex tests abnormal
Clinical narrative: This case was reported in a literature article and described the occurrence of multiple evanescent white dot syndrome in a 53-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject's medical history included pterygium excised. Concurrent medical conditions included hepatitis b and c carrier, polysubstance abuse and rehabilitation. Concurrent medications included Buprenorphine and Naloxone. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unknown route, site of injection and batch number). 10 days after vaccination with Influenza vaccine, the subject presented with a complaint of seeing a purple haze in his right eye. Initial examination revealed corrected visual acuity of 20/25 -2 OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE with agranular foveal appearance. Fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with aparacentral scotoma, which improved over time. The subject was diagnosed with multiple evanescent white dot syndrome. this case was assessed as medically serious by GSK. At the 1-month visit, the subject noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Retinal exudates, Retinal pigment epitheliopathy, Scotoma, Vision blurred, Visual acuity reduced
Clinical narrative: This case was reported in a literature article and described the occurrence of multiple evanescent white dot syndrome in a 53-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject's medical history included pterygium excised. Concurrent medical conditions included hepatitis b and c carrier, polysubstance abuse and rehabilitation. Concurrent medications included Buprenorphine and Naloxone. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unknown route, site of injection and batch number). 10 days after vaccination with Influenza vaccine, the subject presented with a complaint of seeing a purple haze in his right eye. Initial examination revealed corrected visual acuity of 20/25 -2 OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE with agranular foveal appearance. Fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with aparacentral scotoma, which improved over time. The subject was diagnosed with multiple evanescent white dot syndrome. this case was assessed as medically serious by GSK. At the 1-month visit, the subject noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Visual field tests abnormal, Visual impairment
Clinical narrative: This case was reported in a literature article and described the occurrence of multiple evanescent white dot syndrome in a 53-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject's medical history included pterygium excised. Concurrent medical conditions included hepatitis b and c carrier, polysubstance abuse and rehabilitation. Concurrent medications included Buprenorphine and Naloxone. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unknown route, site of injection and batch number). 10 days after vaccination with Influenza vaccine, the subject presented with a complaint of seeing a purple haze in his right eye. Initial examination revealed corrected visual acuity of 20/25 -2 OD and 20/20 OS. Results of pupillary reactions, confrontational visual field, color vision, and intraocular pressure were all within normal limits. An unremarkable anterior segment examination and quiet vitreous were noted. Fundus examination in right eye revealed multiple white lesions at the level of outer retina/RPE with agranular foveal appearance. Fluorescein angiography revealed early multiple punctate hyperfluorescent spots with late staining, which also involved the optic nerve head. Initial Humphrey 30-2 visual field was of low reliability, but follow-up testing revealed residual enlargement of the blind spot with aparacentral scotoma, which improved over time. The subject was diagnosed with multiple evanescent white dot syndrome. this case was assessed as medically serious by GSK. At the 1-month visit, the subject noted improvement in symptoms. Fundus lesions resolved and vision recovered to 20/20.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Hypersomnia, Lethargy, Pyrexia, Somnolence
Clinical narrative: This case was reported by a healthcare professional nurse practitioner) via a sales representative and described the occurrence of crying uncontrollably in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on an unspecified date. On an unspecified date the subject received the 1st dose of PEDIARIX (.5 ml, unknown details). On an unknown date, less than one day after vaccination with PEDIARIX (described as "post vaccination, same day"), the subject experienced crying uncontrollably, lethargy, inability to wake up and low grade fever. The reporter was not certain where the subject received the vaccination. At the time of reporting the outcome of the events of crying uncontrollably, lethargy, inability to wake up were was resolved. At the time of reporting, the outcome of the event of low grade fever was not reported and unknown. The healthcare professional documented that the uncontrollable crying lasted 3 to 4 hours and "then fell asleep for 2 days child did not want to wake up to eat."). It was unknown if the immunization series was delayed or discontinued.
Age: 0.23
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site nodule, Intensive care
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nodule injection site in a 3-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included chronic pulmonary disease, prematurity (born at 23 weeks gestation), reflux (unknown) and retinopathy of prematurity. Concurrent vaccination included pneumococcal vaccines (non-GSK); Wyeth Labs; unknown, unknown given on 18 June 2013. Concurrent medications included CHOLECALCIFEROL, Atropine, EES, Gatifloxacin, Multivitamin with iron and PRED FORTE. On 18 June 2013 at 13:54 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, right thigh). On 19 June 2013, 1 day after vaccination with PEDIARIX, the subject experienced nodule injection site. The pharmacist described the nodule as large. The subject was in the neonatal intensive care unit at the time of reporting. The pharmacist reported that the immunization series was not discontinued or delayed. The pharmacist considered the event was disabling. At the time of reporting the event was improved. The pharmacist reported 4 other cases. See cases A1033993A, A1033995A, A1033996A, and A1033997A for details on the other cases.