chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 18 May 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 12-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; received on 08 July 2011, 12 September 2011 and 02 December 2011 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 27 April 2012, approximately 5 months after the last dose. On 29 April 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 02 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 02 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 18 May 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 12-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; received on 08 July 2011, 12 September 2011 and 02 December 2011 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 27 April 2012, approximately 5 months after the last dose. On 29 April 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 02 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 02 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: YF
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus
Clinical narrative: Received other vaccines 1 month prior but in another facility. Redness and itching at injection site on 5/17. On 5/18 redness turned into dark purple same size.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Joint stiffness, Pyrexia
Clinical narrative: Fever, stiffness to joints, headache, diarrhea.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Convulsion, Staring, Vision blurred
Clinical narrative: Episode of short seizure 1-2 min, staring, no focus, does not remember episode better after 15 min.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash, Rash macular
Clinical narrative: Pt reports about 4 day after vaccines: pink/red "splotches" formed on face/chin/chest. "Terrible headache" top of head to neck. Right side only.
Sex: U
Vaccine: VARZOS
Symptoms: Conversion disorder
Clinical narrative: Patient suffers from pseudo seizures after ZOSTAVAX was administered 10 minutes later patient went into pseudo seizures 911 was called.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt received HPV #1 at 1 yo physical. Approx 1-1 1/2 hrs after vaccine, pt started feeling lightheaded, nauseous, vomited, without temp went to ED - seemed better. Next day low grade temp, nausea, HA.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Band neutrophil percentage, Blood culture positive, CSF culture negative, CSF glucose normal, CSF protein normal
Clinical narrative: Two generalized tonic clonic seizures both lasting approximately 1 min long. (Mother describes "eyes rolled back, arms drawn up, shaking). In ED, pt had full sepsis workup as fever 100.6. EEG performed with results pending.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF white blood cell count, Electroencephalogram, Gaze palsy, Grand mal convulsion, Lymphocyte percentage
Clinical narrative: Two generalized tonic clonic seizures both lasting approximately 1 min long. (Mother describes "eyes rolled back, arms drawn up, shaking). In ED, pt had full sepsis workup as fever 100.6. EEG performed with results pending.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Neutrophil percentage decreased, Neutrophil percentage increased, Posture abnormal, Pyrexia, Red blood cells CSF positive
Clinical narrative: Two generalized tonic clonic seizures both lasting approximately 1 min long. (Mother describes "eyes rolled back, arms drawn up, shaking). In ED, pt had full sepsis workup as fever 100.6. EEG performed with results pending.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Tremor, White blood cell count increased
Clinical narrative: Two generalized tonic clonic seizures both lasting approximately 1 min long. (Mother describes "eyes rolled back, arms drawn up, shaking). In ED, pt had full sepsis workup as fever 100.6. EEG performed with results pending.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Bone pain, Cough, Dysphagia, Dysphonia
Clinical narrative: Fever, ache bones, soreness on Friday 5-25-12; cotton mouth, raw throat, unable to swallow, elevated temperature on Saturday 5-26-12; 5-30-12 Continues with cough, green phlegm, swollen neck, hoarse voice, soreness of bone.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Increased upper airway secretion, Local swelling, Oral disorder, Pain, Pharyngeal disorder
Clinical narrative: Fever, ache bones, soreness on Friday 5-25-12; cotton mouth, raw throat, unable to swallow, elevated temperature on Saturday 5-26-12; 5-30-12 Continues with cough, green phlegm, swollen neck, hoarse voice, soreness of bone.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Fever, ache bones, soreness on Friday 5-25-12; cotton mouth, raw throat, unable to swallow, elevated temperature on Saturday 5-26-12; 5-30-12 Continues with cough, green phlegm, swollen neck, hoarse voice, soreness of bone.
Age: 1.33
Sex: M
Vaccine: PNC13
Symptoms: Ear infection, Pyrexia
Clinical narrative: Patient began to run fever and have double ear infections after have the Prevnar 13 vaccine, has never had even a fever before this, we are still fighting the ear infection today 05/30/2012.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Lipids, Mammogram, Pruritus
Clinical narrative: Swelling, warmness, redness ~6" above and below injection site, blisters, itching, biting itch - resolved after 2 weeks.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Swelling, warmness, redness ~6" above and below injection site, blisters, itching, biting itch - resolved after 2 weeks.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Neck pain, Pain in extremity, Pyrexia, Streptococcus test negative
Clinical narrative: Soreness in arm and neck, high fever. Normal temperature is 96, fever up to 102.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Injection site erythema, Myalgia, Pain
Clinical narrative: 5/28/12 aching pain to deltoid muscle; 5/29/12 approx 1/4 inch redness at injection point; below point increased aching pain and redness developed approx 1/3"; 5/30/12 AM after rising; a second area of redness developed with possible 3 blisters just below starting point of redness, area approx 1X2". Clear area of skin between both areas of redness. Area is not raised but irregular, not rashy appearing.  Client denies itchiness, headache, fever or flu-like symptoms.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Profuse watery diarrhea for 12 hours.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Right deltoid red, hard and swollen per school Nurse. Area approx. 4"X2". Meningitis Vaccine given in that location.  Instructed to ice area and take Tylenol for discomfort.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaphylactic reaction, Dyspnoea, Endotracheal intubation, Extubation, Intensive care
Clinical narrative: Anaphylaxis (shortness of breath; sensation of throat swelling) that started approximately 30 minutes after vaccine dose (Gardasil). This was dose #2. Dose #1 was given on 6/8/2011 with no reported adverse effects.  Pt was seen in local ER. She was intubated and transferred to ICU on 29 May 2012. She was extubated on 30 May 2012. The plan is to transfer her from the ICU to the regular medicine ward for observation later today if she continues to do well. Currently, this is hospital day #2. No other exposures were thought to be responsible for her signs/symptoms.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pharyngeal oedema
Clinical narrative: Anaphylaxis (shortness of breath; sensation of throat swelling) that started approximately 30 minutes after vaccine dose (Gardasil). This was dose #2. Dose #1 was given on 6/8/2011 with no reported adverse effects.  Pt was seen in local ER. She was intubated and transferred to ICU on 29 May 2012. She was extubated on 30 May 2012. The plan is to transfer her from the ICU to the regular medicine ward for observation later today if she continues to do well. Currently, this is hospital day #2. No other exposures were thought to be responsible for her signs/symptoms.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaphylactic reaction, Arthropathy, Burning sensation, Bursitis, Cartilage injury
Clinical narrative: Anaphylaxis (shortness of breath; sensation of throat swelling) that started approximately 30 minutes after vaccine dose (Gardasil). This was dose #2. Dose #1 was given on 6/8/2011 with no reported adverse effects.  Pt was seen in local ER. She was intubated and transferred to ICU on 29 May 2012. She was extubated on 30 May 2012. The plan is to transfer her from the ICU to the regular medicine ward for observation later today if she continues to do well. Currently, this is hospital day #2. No other exposures were thought to be responsible for her signs/symptoms.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Endotracheal intubation, Hypersensitivity, Hypoaesthesia, Intensive care
Clinical narrative: Anaphylaxis (shortness of breath; sensation of throat swelling) that started approximately 30 minutes after vaccine dose (Gardasil). This was dose #2. Dose #1 was given on 6/8/2011 with no reported adverse effects.  Pt was seen in local ER. She was intubated and transferred to ICU on 29 May 2012. She was extubated on 30 May 2012. The plan is to transfer her from the ICU to the regular medicine ward for observation later today if she continues to do well. Currently, this is hospital day #2. No other exposures were thought to be responsible for her signs/symptoms.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle spasms, Musculoskeletal pain, Pain in extremity, Pharyngeal oedema, Pruritus
Clinical narrative: Anaphylaxis (shortness of breath; sensation of throat swelling) that started approximately 30 minutes after vaccine dose (Gardasil). This was dose #2. Dose #1 was given on 6/8/2011 with no reported adverse effects.  Pt was seen in local ER. She was intubated and transferred to ICU on 29 May 2012. She was extubated on 30 May 2012. The plan is to transfer her from the ICU to the regular medicine ward for observation later today if she continues to do well. Currently, this is hospital day #2. No other exposures were thought to be responsible for her signs/symptoms.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Swelling, Tenderness
Clinical narrative: Anaphylaxis (shortness of breath; sensation of throat swelling) that started approximately 30 minutes after vaccine dose (Gardasil). This was dose #2. Dose #1 was given on 6/8/2011 with no reported adverse effects.  Pt was seen in local ER. She was intubated and transferred to ICU on 29 May 2012. She was extubated on 30 May 2012. The plan is to transfer her from the ICU to the regular medicine ward for observation later today if she continues to do well. Currently, this is hospital day #2. No other exposures were thought to be responsible for her signs/symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness at injection site began the morning after the injection.  Redness continued getting worse the following day.  Swelling and pain occurred as well.  Red area was approximately 2-3 inches in diameter.  The reaction was reported to the prescribing physician.  Patient took diphenhydramine and acetaminophen to treat the reaction.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Pallor, Skin tightness, Skin warm
Clinical narrative: 2 days s/p vaccine admin. (L) upper arm with erythema & edema. No hives or diffuse rash. Tautness to skin positive blanching cap refil 2 sec. Warm.
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity, Pertussis, Stress urinary incontinence, Urticaria, Vaccination complication
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of allergic reaction to tetanus shot in a female subject aged between 20 and 29 years old who was vaccinated with Tetanus shot (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date when the subject was "about 22" she received a dose of tetanus shot (details unknown). At an unspecified time after vaccination with tetanus shot, the subject experienced allergic reaction to tetanus shot, hive, whooping cough and cough incontinence. The subject reported that she was allergic to a tetanus shot as she broke out in hives. She stated that she has had whooping cough a couple of times "lately" and when she coughs; she loses lots of urine further described as urine pours out of her. As a result she cannot go anywhere for a few months. At the time of reporting the outcome of the events was unspecified. The subject was inquiring about the possibility of receiving a whooping cough shot.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a consumer (also the subject's mother) and described the occurrence of injection swelling in a 15-month-old male subject who was vaccinated with Dtap vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included ear infection. Concurrent vaccinations included 5 unspecified vaccines; manufacturer unspecified given on the same unspecified date as the Dtap vaccine. Concurrent medications included Multivitamin + fluoride. On an unspecified date the subject received a dose of Dtap vaccine (details unknown) as the 2nd or 3rd dose in the series. Less than one day after vaccination with Dtap vaccine, the subject experienced injection site swelling. The mother reported that the subject experienced "baseball size swelling at the site of the injection". She noted that the subjected received 5 vaccinations that day: 2 in one arm and 3 in the other. As she best recalls, she believed the swelling was with the Dtap site. At the time of reporting the event was resolved.
Age: 0.12
Sex: F
Vaccine: DTP
Symptoms: Crying, Injection site induration, Injection site swelling, Irritability, Vaccination complication
Clinical narrative: This case was reported by a physician (the mother of the patient) and described the occurrence of systemic shot reaction in a 1-month-old female subject who was vaccinated with Diphtheria tetanus pertussis (A or W not known), (manufacturer unspecified). Concurrent vaccination included tetanus toxoid vaccine (manufacturer unspecified) given on unspecified dates following reactions to Diphtheria tetanus pertussis (A or W not known). On 02 July 1985, at 1 month of age, the subject received primary 1st dose of Diphtheria tetanus pertussis (A or W not known). At an unspecified time after vaccination with Diphtheria tetanus pertussis (A or W not known) the subject experienced systemic shot reaction with irritability, injection site induration, inconsolable crying, and swelling injection site. Resolution of irritability and injection site induration was noted (no date specified). Attribution of these same events was indicated to be possible. Outcome of systemic shot reaction, inconsolable crying, and swelling injection site and attribution of these events to vaccination with Diphtheria tetanus pertussis (A or W not known) was not specifically reported (unknown). It was reported that the subject is now 26 years old and the physician (mother) was wondering if her daughter (now grown) would still have reactions to Tdap if given. Similar events occurred in the subject's brother following vaccination with Diphtheria tetanus pertussis (A or W not known). For details on the sibling case, refer to linked case A0943969A. The physician (mother) stopped further Diphtheria tetanus pertussis (A or W not known) vaccinations in the female subject (her daughter) after seeing the same reactions in older son after doses of Diphtheria tetanus pertussis (A or W not known).
Age: 0.17
Sex: M
Vaccine: DTP
Symptoms: Crying, Injection site induration, Injection site swelling, Irritability, Vaccination complication
Clinical narrative: This case was reported by a physician (the mother of the patient) and described the occurrence of systemic shot reaction in a 2-month-old male subject who was vaccinated with Diphtheria tetanus pertussis (A or W not know), manufacturer unspecified). Concurrent vaccination included tetanus toxoid vaccine (manufacturer unspecified) given on an unspecified date when the subject was an adolescent. On unspecified dates at 2, 4, and 6 months of age the subject received primary 1st dose, 2nd dose and 3rd dose of Diphtheria tetanus pertussis (A or W not known). The subject received booster doses (4th dose and 5h dose) of Diphtheria tetanus pertussis (A or W not known) in 1984 and 1987. At unspecified times after each vaccination with Diphtheria tetanus pertussis (A or W not known) the subject experienced systemic shot reaction with inconsolable crying, irritability, injection site induration, high-pitched crying and swelling injection site. Resolution of inconsolable crying, irritability and injection site induration was noted, but not specifically following each dose of Diphtheria tetanus pertussis (A or W not known) received. Attribution of these same events was indicated to be possible, but again, in relation to specific doses was not noted. Outcome of systemic shot reaction, high-pitched crying and swelling injection site and attribution of these events to vaccination with Diphtheria tetanus pertussis (A or W not known) was not specifically reported (unknown). It was reported that the subject is now 29 years old and the physician (mother) was wondering if her son (now grown) would still have reactions to Tdap if given. Similar events occurred in the subject's sister following vaccination with Diphtheria tetanus pertussis (A or W not known). For details on the sibling case, refer to linked case A0943976A.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Barium enema, Crying, Culture stool, Full blood count, Haematochezia
Clinical narrative: Admitted 03/23/12, inconsolable crying and bloody stools x 3 days. GI consult.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intussusception, Metabolic function test, Occult blood, X-ray
Clinical narrative: Admitted 03/23/12, inconsolable crying and bloody stools x 3 days. GI consult.
Sex: M
Vaccine: DTAP
Symptoms: Nonspecific reaction
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of nonspecific reaction in a male subject of unspecified age who was vaccinated with INFANRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject had a history of allergies to various bovine products. Specific details were not provided. On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced nonspecific reaction. At the time of reporting the outcome of the event was unspecified. The lot number was reported as 8C14B140BA from the reporter; however, based on an INFANRIX lot number check, the lot number was updated to AC14B140BA.
Age: 57.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: Drug administered to patient of inappropriate age, Headache, Pain, Pyrexia, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of body pain in a 57-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent medical conditions included penicillin allergy. Concurrent vaccination included pneumococcal vaccine (non-gsk); Merck; unknown; unknown given on 23 January 2012. Concurrent medications included METFORMIN and Lisinopril. On 23 January 2012 the subject received 1st dose of INFANRIX (.5 ml, unknown route, right arm) and experienced inappropriate age at vaccine administration. The subject was older than the indicated age for INFANRIX. On 23 January 2012, less than one day after vaccination with INFANRIX, the subject experienced body pain, fever and headache. It was not clear if PNEUMOVAX was co-suspect or not. At the time of reporting the body pain, fever and headache were unresolved. Follow up information received from the physician on 22 February 2012. The physician reported that the events resolved on 31 January 2012. The physician considered the events unrelated to the INFANRIX vaccination. The physician noted that the events could have been due to erroneous administration described as the "nurse chose wrong vaccine". It was also noted in the suspect drug section that the subject was "given the wrong dose of vaccine" (no dose in label for subject for this age). The physician selected that no action was taken with INFANRIX, that the INFANRIX was not reintroduced and that the INFANRIX immunization series was discontinued. The physician noted that the subject had not received INFANRIX before.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a physician and described the occurrence of injection site reaction in a 5-year-old subject (now age 11 at the time of reporting) of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date (years prior) the subject received unspecified dose of INFANRIX. At an unspecified time after vaccination with INFANRIX, the subject experienced a severe local injection site reaction. At the time of reporting the outcome of the event was unspecified. No additional details were provided. The physician was wondering, now that the subject is 11 years old, if the Tdap vaccine was contraindicated for this subject. Follow up information received from the physician on 24 January 2012. The physician noted that there was no information available about the subject. He explained that his call to GlaxoSmithKline was in response to a telephone consultation and conversation with another physician. No further information was provided.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Throat irritation, Urticaria
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of hive-like rash in a 3-year-old male subject who was vaccinated with Dtap vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. There were no concurrent medications. In June 2004 the subject received unspecified dose of Dtap vaccine in an unknown arm. In June 2004, immediately after vaccination with Dtap vaccine, the subject experienced a hive-like rash that began to crawl up his neck and face and he experienced a scratchy throat. At the time of reporting the events were resolved. It was noted that two years ago, this subject was given a tetanus booster (unspecified) without any such side effects. It was noted that the dose of Dtap vaccine given was the second of it's kind in the childhood immunization series.
Age: 0.39
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hives in a 4-month-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). The subject has a history of developing hives following administration of PEDIARIX at her two month visit. On 6 June 2011 at 13:30 the subject received unspecified dose of INFANRIX at 0.5 ml in the left leg. On 7 June 2011, 1 day after vaccination with INFANRIX, the subject experienced hives. The subject was treated with BENADRYL prior to vaccination with INFANRIX. At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with INFANRIX. For details regarding the event following administration of PEDIARIX at the subject's two months visit, refer to case number A0935245A.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Aphagia, Crying, Irritability
Clinical narrative: This case was reported by a physician and described the occurrence of crying uncontrollably in a 2-month-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included Hib (manufacturer unspecified), IPV (manufacturer unspecified) and PREVNAR (PFIZER) all given on 18 April 2011 while in a foreign country. Concurrent medications included Paracetamol (given just after vaccination). On 18 April 2011 while the subject was in a foreign country, she received 1st dose of INFANRIX at 0.5 ml in an unknown thigh. One and a half hours following vaccination, the subject was crying unstoppably for greater than three hours until she fell asleep. During that time the subject was unable to eat "due to crying" even though she was hungry. After a nap, the child was still irritable and unable to eat properly. It was noted that crying and inability to eat ended the following day, 19 April 2011. Outcome of irritability was not stated.
Age: 3.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Hypersensitivity, Incorrect route of drug administration, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 3-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR vaccine (non-gsk); Merck given on 17 May 2011; varicella virus vaccine (non-gsk); Merck given on 17 May 2011. There were no concurrent medications. On 17 May 2011 at 11:00 the subject received 4th dose of INFANRIX (.5 ml, subcutaneous, left thigh). INFANRIX was given subcutaneously (intramuscular formulation administered by other route). On unspecified date(s) in May 2011, on or before 19 May 2011, an unspecified time after vaccination with INFANRIX, the subject experienced the local reactions of redness and swelling (injection site redness and swelling injection site). The subject's mother had notified the healthcare professional's office of the reactions on 19 May 2011. The subject's mother was asked to bring the subject in; however, at the time of reporting on 19 May 2011, the subject had not been seen. The reporting nurse stated there was a local reaction of redness and swelling according to the subject's mother. At the time of reporting, it was unknown when the reactions started. At the time of reporting the outcome of the events was unspecified. The healthcare profession considered the injection site redness was unrelated to vaccination with INFANRIX. Causality was not provided for swelling injection site. Follow-up information received on 13 June 2011 indicated that the subject experienced a local reaction with an allergic component. Injection site redness and swelling injection site were reported previously. The events began on 18 May 2011 and resolved on an unspecified date. The events were not considered to be related to treatment with INFANRIX, MMR vaccine and varicella virus vaccine were given subcutaneously.
Sex: M
Vaccine: DTAP
Symptoms: Adverse drug reaction, Decreased immune responsiveness, Injection site swelling, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling injection site in a male subject of unspecified age who was vaccinated with INFANRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included anaphylactic reaction to food. Previous and/or concurrent vaccination included PEDIARIX; GlaxoSmithKline; unknown; unknown given on an unspecified date. Concurrent medications included EPIPEN. On an unspecified date the subject received 2nd dose of INFANRIX (unknown, unknown leg). At an unspecified time after vaccination with INFANRIX, the subject experienced swelling injection site. The mother of the subject was concerned about her son receiving a 3rd dose of INFANRIX vaccine after receiving a DECADRON injection on 03 May 2011 and contracting an illness as well as having reduced immune response because of receiving the steroid. The mother reported with the previous dose of INFANRIX the subject experienced swelling. She clarified the swelling was at the injection site on the leg. She stated this would be the third dose of INFANRIX and the injection site swelling was with the previous dose of INFANRIX. At the time of the report, the outcome of the injection site swelling was unknown and the reporter refused to be contacted for follow-up.
Age: 1.11
Sex: F
Vaccine: DTAP, PNC, VARCEL
Symptoms: Expired drug administered, Injection site rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of the use of expired vaccine in a 13-month old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included varicella virus vaccine (non-GSK) (manufacturer unspecified) and PREVNAR (manufacturer unspecified) both given on 14 April 2011. There were no concurrent medications. On 14 April 2011 the subject inadvertently received an expired dose of INFANRIX in the left thigh. On an unspecified date, the same month after vaccination with INFANRIX, the subject experienced a rash on her left lower leg. The outcome of the event was not known. No additional information was provided. This event occurred in four subjects. Linked cases include A925197A, A0925203A and A0925204A. Follow-up received on 03 October 2011 from the healthcare professional: The healthcare professional also considered the varicella virus vaccine, which was administered in the same leg as INFANRIX (left thigh), to be a suspect vaccine. The event of leg rash resolved on an unspecified date. The healthcare professional considered that the event was not associated with medical history or a concurrent illness, lack of efficacy, erroneous administration, nor suspected transmission of an infectious agent via a medicinal product. The healthcare professional reported that the event may have been associated with the outdated vaccine.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Decreased appetite, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer (patient's grandmother) and described the occurrence of low grade fever in a 2-month-old male subject who was vaccinated with DTAP vaccine (manufacturer unspecified), Rotavirus vaccine, Haemophilus influenzae type b vaccine and poliomyelitis vaccine inactivated (non-gsk). A physician or other health care professional has not verified this report. The subject's medical history included constipation, drug reaction and thrush. Concurrent medical conditions included sensitive to chemicals. On 16 December 2008 the subject received unspecified dose of DTAP vaccine  (details unknown), 1st dose of Rotavirus vaccine (details unknown), 1st dose of Haemophilus influenzae type b vaccine (details unknown), 1st dose of Poliomyelitis vaccine inactivated (Non-GSK) (details unknown). In December 2008, less than one week after vaccination with DTAP vaccine, Haemophilus influenzae type b vaccine, Poliomyelitis vaccine inactivated (Non-GSK) and Rotavirus vaccine, the subject experienced low grade fever, soreness and loss of appetite. The subject experienced the events after the vaccinations and the symptoms lasted for 2 to 3 days. In December 2008, the events were resolved. On 23 March 2010, the subject was vaccinated with Hepatitis A vaccine and experienced some of the same events plus different events. See case A0970857B for details. On 09 March 2012, the subject was vaccinated with HAVRIX and experienced some of the same events plus different events. See case A0970857C for details. Follow-up information was received on 27 April 2012 via consumer (subject's grandmother) who provided the subject's immunization record. On 16 December 2008, the subject received 1st dose DTPA-IPV-HIB, 1st dose ROTATEQ (other manufacturer), 2nd dose of Hepatitis B vaccine and 1st dose PREVNAR. The subject has had a long history of reactions to vaccines.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: This case was reported by a healthcare professional (nurse supervisor), via a sales representative, and described the occurrence of injection site tenderness in a 4-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included MMR vaccine (non-gsk); non-GSK manufacturer; unknown route; left thigh given on 5 December 2011. Concurrent medications included Tuberculin. On 5 December 2011 at 09:54 the subject received 5th dose of INFANRIX (.5 ml, unknown route, left thigh). On 7 December 2011, 2 days after vaccination with INFANRIX, the subject experienced injection site tenderness, injection site warmth, tightness at injection site and swollen thigh. The healthcare professional reported that the skin was tender, warm and tight to the touch at and surrounding the injection site and the "whole thigh area" was swollen. The healthcare professional explained that injection site of the other vaccine was administered in the same leg; however, the events were clearly seen to be generated from the INFANRIX site. The other vaccine was not considered co-suspect according to the healthcare professional. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with INFANRIX. Follow-up information was received on 3 January 2012 from the healthcare professional. On 6 December 2011, 1 day after vaccination with INFANRIX, the subject experienced injection site tenderness, injection site warmth, tightness at injection site and swollen thigh (updated from the previously reported onset date of 7 December 2011). No biopsy was performed. The healthcare professional considered all the events non-serious. All the events resolved on 09 December 2011.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth, Local reaction
Clinical narrative: Local reaction at injection site 8-9 inches long oval rash w/ darker 2-3 inches long oval center - warm to touch. Treatment w/ cool compress and BENADRYL - observation.
Sex: F
Vaccine: DTAP
Symptoms: Injection site rash, Laboratory test, Rash
Clinical narrative: This case was reported by a consumer (the subject's grandmother), via another manufacturer (Merck), and described the occurrence of leg rash in a female subject of unspecified age who was vaccinated with DTAP vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of DTAP vaccine (details unknown). In August 2010, at an unspecified time after vaccination with DTAP vaccine, the subject experienced rash on her legs and injection site rash. The subject was taken to an allergist and unspecified tests were performed with unspecified results. At the time of reporting the outcome of the events was unspecified. The consumer reported that "while on" DTAP vaccination, in August 2010 her granddaughter experienced a rash on her legs and near the injection site.
Age: 75.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Abscess limb, Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Pt developed painful erythema of (R) deltoid which migrated down her arm 5/16/12 cellulitis and abscess of upper arm and forearm. Treated w/ cephalexin 250mg QID x 10 days.
Age: 36.0
Sex: F
Vaccine: TYP, YF
Symptoms: Induration, Pruritus, Urticaria
Clinical narrative: After receiving YF vaccine (L) tricep region (SC) pt developed pruritic wheal about 6 x7 cm. Induration/min warm non tender. Without adenopathy.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Culture urine, Decreased appetite, Pyrexia, Urine analysis, Vomiting
Clinical narrative: Fever & vomiting began about 12 hours after vaccinations. Anorexia [decrease in appetite] as well. TYLENOL alternating with ibuprofen did normalize fever. Fever to 104 degrees F. Questionable dysuria within 24 hours after vaccination.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gaze palsy, Head injury, Loss of consciousness, Tremor
Clinical narrative: Pt was a check out and passed out. She fell backward and hit her head on door frame. Her eyes rolled back and she started to shake for 20 seconds.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram head normal, Dizziness, Electroencephalogram normal, Head injury, Loss of consciousness
Clinical narrative: Pt was a check out and passed out. She fell backward and hit her head on door frame. Her eyes rolled back and she started to shake for 20 seconds.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle twitching, Nuclear magnetic resonance imaging
Clinical narrative: Pt was a check out and passed out. She fell backward and hit her head on door frame. Her eyes rolled back and she started to shake for 20 seconds.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Deafness, Immediate post-injection reaction, Irritability, Unresponsive to stimuli
Clinical narrative: Mom noted immediate fussiness, then suspected loss of hearing- patient would make noises (repetitive), almost as if trying to see if she can hear herself. Specialists noted that she would not turn to noise in either ear with banging on pots. Another office noted similar findings with clapping. Mom notes that she started responding again to noises in the right ear the week of 5/15 and in the left ear 5/25/12.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Tdap was administered to a 7y/o boy who was not up to date on his Dtaps. Injection was given on 5/16/12. Patient had app't on 5/18/12 to be evaluated for swelling, redness and pain in (L) upper arm. Advised to use ice to reduce swelling & ZYRTEC to control itching.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site warmth, Pain in extremity
Clinical narrative: Patient displayed a bruise-like appearance at the injection site that spreaded outward, it's warm to the touch and pt is experiencing pain throughout the left arm. Patient was advised to follow-up with MD and came back to the pharmacy with an Rx for an antibiotic on 5/29/12.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Neck pain
Clinical narrative: Client reports headache and neck ache beginning 5/24/12. Denies any further reactions.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Convulsion, Dizziness, Loss of consciousness, Syncope
Clinical narrative: More severe lightheadedness, 112/70 HR 50. Blackout, seizure < 30 sec. Diag: faint from needle shot.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: Cellulitis. Inflammation, pain, itching at vaccine site.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Skin warm, Tenderness
Clinical narrative: The day after the injection, I noticed a 3 inch solid red raised welt that was very warm to the touch. After several days, the welt began to break up into individual bumps. This continued and became itchy and a little sensitive. By 7 days, my arm was back to normal.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: The day after the injection, I noticed a 3 inch solid red raised welt that was very warm to the touch. After several days, the welt began to break up into individual bumps. This continued and became itchy and a little sensitive. By 7 days, my arm was back to normal.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash
Clinical narrative: Infection given on 5/26/12. Pt reported she developed a rash on 5/27/12 she presented at pharmacy on 5/29/12 to show us redness in area of vaccine pt. is still recovering.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria, Pruritus.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature, Headache, Injection site erythema, Injection site induration, Neck pain
Clinical narrative: Patient reports hardening and redness at injection site along with mild swelling to (R) forearm. Also report feeling like "I was running a temperature". Pt. denies checking temperature. Also reports headache and neck ache on 5/24/12.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Oedema peripheral
Clinical narrative: Patient reports hardening and redness at injection site along with mild swelling to (R) forearm. Also report feeling like "I was running a temperature". Pt. denies checking temperature. Also reports headache and neck ache on 5/24/12.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Joint swelling, Pruritus
Clinical narrative: Redness, swelling and itchy on right arm. Refer to his PCM in clinic because of nationality.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt. has redness, warm to touch & itching at injection site - tx w/ topical corticosteroid by dermatologist (happened to have appt 5/30/12).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Redness, small lump, warm to touch & pain at injection site - treated for cellulitis w/ abx.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Injection site warmth
Clinical narrative: Pt got infection at injection site. Red, warm to touch & hard. Pt put on antibiotic.
Age: 1.43
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL, DTPPHIB, HEPA, MEA, PNC, VARCEL, DTAP, HEPA, HIBV, IPV, MMR, PNC, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Autism, Communication disorder, Decreased eye contact, Dysphagia, Eating disorder
Clinical narrative: Information has been received from a consumer concerning a 17 month old male with intestinal bacteria flora disturbance, coeliac disease, flour sensitivity and allergy to chemicals and a history of oral candidiasis, candidiasis of the intestine, adverse drug reaction (MIRALEX), psychotic disorder, confusion, diarrhoea, bloating, does not detoxify and yeast infection. The patient also experienced some of the same and other adverse events after DTaP vaccine on 16-DEC-2008 (case #A0970857A). The patient was born with thrush in mouth and intestines because mom took antibiotics on and off during pregnancy for tooth abscess. Patient's mom was taking birth control shots every three months when she became pregnant. Mom also took omeprazole (unspecified) for reflux during 3rd trimester. Grandmother reports patient's mom did have prenatal care, however was unaware of pregnancy initially. Grandmother reports he tolerated antibiotics well for 3 months, but didn't have any flora in his system. Patient has sibling that is 6 years of age, without any medical issues, from different father. The older brother has been adopted to another family. The patient on 23-MAR-2010 was vaccinated with VARIVAX (Merck), (dose, route and lot # not reported). Secondary suspect included MMR II (dose, route and lot # not reported), VAQTA, DTaP+IPV+HIB, PREVNAR. Concomitant therapy included nutritional supplements. On approximately 30-MAR-2010 (reported as less than one week) the patient experienced high grade fever up to 105 and loss of appetite. On approximately 06-APR-2010 (reported as 2 to 3 weeks after vaccination) the patient experienced chicken pox. On approximately 23-APR-2010 (reported as about one month after vaccination) the patient experienced weight loss, loss of fine motor skills, non communicative, dysphagia and loss of making eye contact. The reporter said that the subject lost about 50 percent of his weight and 80 percent of his fine motor skills. In approximately June 2010 (reported as about 4 month after vaccination), the patient experienced autism. Subsequently in 2010 the patient experienced diarrhea, increase tantrums and loss of all speech. At the time of the report, the grandmother explained that the subject had recovered to about 90 percent and now attended a school for special education student. At the time of reporting the outcome of the events was unspecified except the autism was considered as improved. The patient also experienced adverse events after HAVRIX (administered on 09-MAR-2012) and experienced some of the same events plus different events (case #A0970857C). Upon internal review, loss of all speech was determined to be as other important medical event. No further information is available.