chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain, Swelling
Clinical narrative: Reddened injection site, swelling and pain, still visible as of 9/17/12.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Epistaxis, Eye discharge, Eye irritation
Clinical narrative: It started with a persistent cough with difficulty breathing and a congested feeling. By 3:00 AM, I had a severe headache as well as red eyes with some burning as well as a stickiness that made opening my eyes difficult. The headaches continued through the day, though advill helped alleviate the pain. I also got a nosebleed as well, though I don't know whether it was related.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid function disorder, Headache, Ocular hyperaemia, Respiratory tract congestion
Clinical narrative: It started with a persistent cough with difficulty breathing and a congested feeling. By 3:00 AM, I had a severe headache as well as red eyes with some burning as well as a stickiness that made opening my eyes difficult. The headaches continued through the day, though advill helped alleviate the pain. I also got a nosebleed as well, though I don't know whether it was related.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Vomiting, nausea, fever, headache, body ache lasting 6 days thus far.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Eye irritation
Clinical narrative: Burning in eyes
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Bipolar disorder, Bradyphrenia, Convulsion, Dyspnoea, Emphysema
Clinical narrative: This case was reported by a consumer and described the occurrence of seizure in a 49-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included hive and penicillin allergy. On an unspecified date in November 2008 at approximately 10:00 the subject received 1st dose of HAVRIX (unknown, right arm). Lot number was reported as "AHVB173AA". In November 2008, at an unspecified time after vaccination with HAVRIX, the subject experienced irregular bleeding in menstrual area, shortness of breath, hernia from pushing stock around and ovarian cyst. At an unspecified time after vaccination with HAVRIX, the subject experienced seizure, bipolar disorder, thinking slow and "people seemed like they were talking to fast and everything around her seemed to be going fast" (ill defined disorder). Her shortness of breath turned into emphysema so she has been sent for CPAP and "VPAP" [unknown] testing. She also experienced seizures, bipolar disorder, thinking was slow, people seemed like they were talking to fast and everything around her seemed to be going fast. These issues were treated with Lamotrigine which seems to be helping. She stated that she had uterine surgery and removal of both ovaries. She has been placed on estrogen to help slough off inside of uterus. This case was assessed as medically serious by GSK. At the time of reporting the irregular menstrual bleeding, shortness of breath, hernia and ovarian cyst were unresolved. The outcome of seizure, bipolar disorder, thinking slow and ill defined disorder were unspecified.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Hernia, Ill-defined disorder, Menstruation irregular, Oophorectomy bilateral, Ovarian cyst
Clinical narrative: This case was reported by a consumer and described the occurrence of seizure in a 49-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included hive and penicillin allergy. On an unspecified date in November 2008 at approximately 10:00 the subject received 1st dose of HAVRIX (unknown, right arm). Lot number was reported as "AHVB173AA". In November 2008, at an unspecified time after vaccination with HAVRIX, the subject experienced irregular bleeding in menstrual area, shortness of breath, hernia from pushing stock around and ovarian cyst. At an unspecified time after vaccination with HAVRIX, the subject experienced seizure, bipolar disorder, thinking slow and "people seemed like they were talking to fast and everything around her seemed to be going fast" (ill defined disorder). Her shortness of breath turned into emphysema so she has been sent for CPAP and "VPAP" [unknown] testing. She also experienced seizures, bipolar disorder, thinking was slow, people seemed like they were talking to fast and everything around her seemed to be going fast. These issues were treated with Lamotrigine which seems to be helping. She stated that she had uterine surgery and removal of both ovaries. She has been placed on estrogen to help slough off inside of uterus. This case was assessed as medically serious by GSK. At the time of reporting the irregular menstrual bleeding, shortness of breath, hernia and ovarian cyst were unresolved. The outcome of seizure, bipolar disorder, thinking slow and ill defined disorder were unspecified.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Uterine operation
Clinical narrative: This case was reported by a consumer and described the occurrence of seizure in a 49-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included hive and penicillin allergy. On an unspecified date in November 2008 at approximately 10:00 the subject received 1st dose of HAVRIX (unknown, right arm). Lot number was reported as "AHVB173AA". In November 2008, at an unspecified time after vaccination with HAVRIX, the subject experienced irregular bleeding in menstrual area, shortness of breath, hernia from pushing stock around and ovarian cyst. At an unspecified time after vaccination with HAVRIX, the subject experienced seizure, bipolar disorder, thinking slow and "people seemed like they were talking to fast and everything around her seemed to be going fast" (ill defined disorder). Her shortness of breath turned into emphysema so she has been sent for CPAP and "VPAP" [unknown] testing. She also experienced seizures, bipolar disorder, thinking was slow, people seemed like they were talking to fast and everything around her seemed to be going fast. These issues were treated with Lamotrigine which seems to be helping. She stated that she had uterine surgery and removal of both ovaries. She has been placed on estrogen to help slough off inside of uterus. This case was assessed as medically serious by GSK. At the time of reporting the irregular menstrual bleeding, shortness of breath, hernia and ovarian cyst were unresolved. The outcome of seizure, bipolar disorder, thinking slow and ill defined disorder were unspecified.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV, RV1
Symptoms: Culture stool negative, Diarrhoea, Incorrect route of drug administration, Irritability, Parasite stool test negative
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of diarrhea in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), PENTACEL (non-gsk) and pneumococcal vaccines (non-gsk). Concurrent medical conditions included possible gastrointestinal virus. Concurrent vaccination included hepatitis B vaccine recombinant ;manufacturer unspecified; intramuscular;unknown given on 16 April 2012. On 16 April 2012 the subject received 1st dose of ROTARIX (intramuscular, unknown), unspecified dose of PENTACEL (intramuscular, unknown), unspecified dose of Pneumococcal vaccines (Non-GSK) (intramuscular, unknown) and experienced inappropriate route of vaccination with ROTARIX. The ROTARIX was administered by intramuscular injection instead of orally as indicated. On 16 April 2012, 2 days after vaccination with PENTACEL, Pneumococcal vaccines (Non-GSK) and ROTARIX, the subject experienced diarrhea and fussiness. According to the nurse, the subject had watery diarrhea for 12 days, but the nurse reported the recovery date for water diarrhea as 18 May 2012 and indicated that it could be a concurrent condition. The nurse noted the events could have been associated with exposure to gastrointestinal (GI) virus in the physician's office. No action was taken with ROTARIX series. The subject received first oral dose of ROTARIX at 4 month well check up on 18 June 2012 and "no problems occurred". The nurse planned for the 2nd ROTARIX oral dose to be given at 6 month well check up in August 2012. Relevant test results included stool culture with normal flora on 10 May 2012 and OVA and Parasite negative on 16 May 2012. On 20 April 2012 the fussiness was resolved and on 18 May 2012 the watery diarrhea and GI virus were resolved. The healthcare professional explained that the vaccine was reconstituted correctly and a new needle and syringe were used to withdraw the vaccine from the vial and administer intramuscularly. The healthcare professional noted that the maladministration occurred because the nurse did not attend training in services or read given literature on ROTARIX. It was reported that six subjects were administered ROTARIX by intramuscular injection. See cases A0981435A, A0983047A, A0983051A, A0983052A, and A0983053A for details regarding the other five cases.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Electroencephalogram normal, Partial seizures
Clinical narrative: Focal seizure after administration of DTAP vaccine.
Age: 0.2
Sex: U
Vaccine: RV1
Symptoms: Faeces discoloured, Haematochezia, Occult blood positive, Vomiting
Clinical narrative: This case was reported by a physician and described the occurrence of vomiting in a 2-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subjects received unspecified dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced vomiting, heme-positive stool that were dark green. The 2-month-old subject was at a WCC (well child care) visit and received ROTARIX. Approximately one week later started with vomiting (intermittent, large amount one to two times per day for a week, plus dark green (heme positive) stools for two weeks. This report was received second hand from a vaccine congress meeting, so this is possibly additional information or duplicate case. At the time of the report no other information was available. At the time of reporting the vomiting, heme-positive stool that were dark green were resolved.
Age: 0.27
Sex: F
Vaccine: RV1
Symptoms: Haematochezia, Vaccination complication
Clinical narrative: This case was reported by a physician, via a sales representative, and described the occurrence of blood in stools in an infant subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ROTARIX (details unknown). One day after vaccination with ROTARIX, the subject experienced blood in stools. The infant went to the physician's office for a well visit and was administered the ROTARIX vaccine. The physician was notified the following day that the infant had blood in stool. No additional details were provided. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. Follow up information was received from the physician on 13 March 2012. On 23 January 2012, the 3-month-old female subject received 1st dose of ROTARIX (oral route). On 27 January 2012, 4 days after vaccination with ROTARIX (the physician noted it was 3 days but the dates indicated 4 days), the subject experienced blood in stools and was diagnosed as having a reaction to ROTARIX. On 31 January 2012, the event was resolved. The physician considered the event was probably related to ROTARIX. The physician noted that the event was not serious, but then indicated that the event jeopardized the patient or required intervention. The physician explained that the subject's stool was monitored daily for 2 to 3 days by keeping in contact with the mother. The physician noted that the event could have been associated with the subject's medical history, but noted it was "hard to say, patient was not exposed to anybody with diarrhea". According to the physician, the ROTARIX series was discontinued.
Sex: U
Vaccine: RV1
Symptoms: Product reconstitution issue, Retching
Clinical narrative: This case was reported by a healthcare professional via a GSK sales representative and described the occurrence of gagging on medication in infant subjects of genders who were vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified dates the subjects received a dose of ROTARIX (details unknown) and experienced gagging on medication. The healthcare professional reported that they were having multiple issues reconstituting ROTARIX. It was not mixing up no matter how much shaking the vial and several babies who received the vaccine were gagging after taking ROTARIX. At the time of reporting, no further information was available. At the time of reporting the outcome of the event was unspecified. This case was reported as a product complaint. An investigational report received via GlaxoSmithKline quality assurance on 28 February 2012 indicated that no lot number was available and there was no sample of return. Based on the fact that no precise technical problem considered this complaint as unsubstantiated.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Patient complaining of pain at injection site. Area warm to touch. No signs of infection. Pt received diphenhydramine.
Age: 0.33
Sex: M
Vaccine: RV1, UNK
Symptoms: Vomiting
Clinical narrative: This case was reported by a consumer (subject's father) and described the occurrence of threw up in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other healthcare professional has not verified this report. Concurrent vaccination included two unspecified vaccines ;manufacturer unspecified ;unknown given on 11 November 2012. On 11 November 2011 at 16:00 the subject received unspecified dose of ROTARIX (oral). On 11 November 2012, at 17:00, 1 hour after vaccination with ROTARIX, the subject experienced threw up The subject's father consulted with a healthcare professional. At the time of reporting the outcome of the event was unspecified.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Lightheaded, dizzy, 11:45A -> 12:30P - pt stayed stationary, symptoms resolved. Elevated BP (180/87) 11:45A (157/92) 12:30P - pt states this is normal, treated but uncontrolled.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Chest pain
Clinical narrative: Stabbing chest pains off & on.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Cyanosis, Erythema, Oedema peripheral, Skin discolouration
Clinical narrative: Swelling on right arm, black, blue and red. 6 x 6 cm bruising. No fever, some tenderness.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Swelling on right arm, black, blue and red. 6 x 6 cm bruising. No fever, some tenderness.
Age: 38.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Abdominal discomfort, Arthralgia, Pain, Pyrexia
Clinical narrative: Fever 106.7 degrees F starting one day after Tdap & PNEUMOVAX. Abdominal discomfort, body aches, joint pain.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Red, swollen, hot injection site. Fever/chills, myalgias, four days post injection. Given MEDROL - dose pak 9/17.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Red, swollen, hot injection site. Fever/chills, myalgias, four days post injection. Given MEDROL - dose pak 9/17.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Pallor, Syncope
Clinical narrative: About 3 minutes after vaccine, he turned pale and fainted, he felt weak for 10 minutes. He denied chest pain, SOB, nausea, or vomiting. His BP was normal 10 minutes after event.
Age: 12.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Body temperature increased, Burning sensation, Hypersensitivity, Pruritus, Rash generalised
Clinical narrative: Mom reports that child developed rash over entire body & c/o burning up. Child's temp was 102 degrees. Mom brought child back to H.D. RN looked at rash after hosp. ER visit. Child still has rash over entire body but he states much improved. RN obtained hosp ER record. See attached. Allergic reaction. Had immunizations yesterday at Health Department. Anterior & posterior trunk and upper ext. 97% O2 sat. DEPO-MEDROL 80mg IM. VISTARIL 50mg IM. Hydroxyzine 25mg PO q 6 hours PRN itching. RTC in AM or earlier if symptoms persist.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Wheezing approximately 2 hours after injection of FLUZONE.
Age: 39.0
Sex: F
Vaccine: RV1
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of burning eyes (eye irritation) in a 39-year-old female subject who was accidentally exposed to ROTARIX while preparing the vaccine for administration. Concurrent medical conditions included contact lenses. Concurrent medications included CONCERTA. On 27 October 2011 at 11:45 the subject accidentally was exposed a dose of ROTARIX (intraocular) while preparing drug for administration. On 27 October 2011, less than one day after accidental exposure to eye with ROTARIX, the subject experienced burning eyes (eye irritation). The subject inadvertently got ROTARIX vaccine or diluent alone in her eye when she was mixing the vaccine. The subject stated that the eye burned. She removed the contact lens and flushed the eye with water for at least 5 minutes. At the time of reporting, the burning eyes (eye irritation) was improved, but the eye was still irritated.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Infantile spitting up
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of infantile spitting up in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included PENTACEL (Sanofi Pasteur MSD) and PREVNAR 13 (Wyeth Labs) both given on 27 September 2011. There were no concurrent medications. On 27 September 2011 at 10:30 the subject received 1st dose of ROTARIX (oral). On 27 September 2011, less than one day after vaccination with ROTARIX, the subject experienced infantile spitting up. It was reported that the baby spit up everything that his mother fed him and according to the mother, the child has never spit up. At the time of reporting the outcome of the event was unspecified.
Age: 0.3
Sex: M
Vaccine: RV1
Symptoms: Contusion, Diet refusal, Irritability, Tongue discolouration
Clinical narrative: This case was reported by a physician and described the occurrence of fussy in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 8 September 2011 the subject received unspecified dose of Rotavirus vaccine (oral). Less than one month after vaccination with Rotavirus vaccine, the subject experienced fussiness, refusal to eat and discolored area under tongue. At the time of reporting the outcome of fussiness and refused to eat was unspecified. Attribution of these events to vaccination with Rotavirus vaccine was not known. Discoloration under tongue resolved on an unspecified date. This event was considered unrelated to vaccination with Rotavirus. Follow-up received from the physician on 12 October 2011: The physician reported that the original reporter of the adverse event was a child abuse specialist and the physician did not agree with what was reported. The physician believed that the subject had a bruise and that the vaccine did not cause an adverse event. The physician confirmed that she did not believe that the subject experienced an adverse event.
Sex: U
Vaccine: RV1
Symptoms: Dehydration, Diarrhoea
Clinical narrative: This case was reported by a physician, via a GSK representative, and described the occurrence of diarrhea in approximately 5 to 10 infant subjects of unspecified gender who were vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subjects received 1st dose of ROTARIX (details unknown). At an unspecified time after vaccination with ROTARIX, the subjects experienced diarrhea. At the time of reporting the event was resolved. The physician reported that diarrhea had been observed in several (approximately 5 to 10) subjects following the 1st dose of ROTARIX (this case). One infant had been hospitalized for dehydration due to severe diarrhea (see case ID A0951277A).
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, RV1
Symptoms: Diarrhoea, Irritability, Vomiting
Clinical narrative: This case was reported by a consumer (subject's father) and described the occurrence of diarrhea in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included Hib vaccine; manufacturer unspecified; unknown; unknown given in January 2012; DTaP vaccine; manufacturer unspecified; unknown; unknown given in January 2012. In January 2012 the subject received 1st dose of ROTARIX (oral). In January 2012, less than one month after vaccination with ROTARIX, the subject experienced diarrhea, throwing up, cranky and sleep more hours at night. At the time of reporting the events were unresolved.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Injection site pain
Clinical narrative: Vaccine received 9-7-12. Incurred 102 degrees temp on 9-9-12, relieved by TYLENOL. Arm, at injection site, sore 9-10-12 no swelling.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Vertigo
Clinical narrative: Received vaccination 9/7/12 at 09:30 am, at 21:30 same day had dizzy spell - room spinning. Since has had 3-4 episodes per day - that last 10-15 minutes.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Headache, Mobility decreased, Swelling, Swelling face
Clinical narrative: Headache 20 mins after injection on Thursday. Friday had cellulitis around area was given KEFLEX on Sat couldn't move arm or neck very well. Very swollen up into facial area and back.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Abdominal pain upper, Incorrect drug dosage form administered, Irritability
Clinical narrative: This case was reported by a consumer and described the occurrence of stomach pain in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. On 20 July 2011 the subject received 1st dose of ROTARIX at 1.0 ml, orally. It was discovered that the ROTARIX vaccine administered was prepared with diluent from chicken pox and measles vaccine. This was the wrong solution used for drug reconstitution. On the afternoon of 20 July 2011, less than one day after vaccination with ROTARIX, the subject experienced stomach pain and irritability. At the time of reporting the events were unresolved.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Arthralgia, C-reactive protein normal, Full blood count normal, Headache, Pyrexia
Clinical narrative: (Fever, rash) (Serum sickness) (Headache, joint pains) x 7 days.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Rash, Serum sickness
Clinical narrative: (Fever, rash) (Serum sickness) (Headache, joint pains) x 7 days.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Diarrhoea, Headache, Myalgia
Clinical narrative: 9/17/12 received call from client to report reactions following receipt of Tdap vaccine. States experienced headache "severe", diarrhea, muscle aches and weakness. States has recovered.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Skin warm, Vaccination complication
Clinical narrative: Received Tdap vaccine 9/10/12. Called 9/17/12 to state has experienced soreness x 7 days since adm. of Tdap vaccine. Denies any redness or streaks states warm to touch. S & S of mild-mod. reaction to Tdap vaccine reviewed per VIS. Encouraged to contact PCP.
Age: 10.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP, VARCEL
Symptoms: Chills, Oedema peripheral, Pain, Rash
Clinical narrative: 9/14/12 Rash, swelling on (L) arm, c/o of chills and body aches. Temp - 98.4 F on visit.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient received ZOSTAVAX on 9/8/12 and reported to the pharmacy on 9/12/12 complaining of rash around the injection site. Rash was localized to the back of the arm, about 2 inches wide by 4 inches in length.
Age: 1.16
Sex: U
Vaccine: DTAPHEPBIP, FLU3, MMR
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration
Clinical narrative: None reported.
Sex: U
Vaccine: RV1
Symptoms: Haematochezia
Clinical narrative: This case was reported by a physician and described the occurrence of blood in stools in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On 27 July 2011 the subject received unspecified dose of ROTARIX (unknown). On 31 July 2011, 4 days after vaccination with ROTARIX, the subject experienced blood in stools. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever / chills / arm redness & swelling & pain around injection site of Left arm - site of PNEUMOVAX.
Age: 1.03
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Decreased appetite, Injection site erythema, Injection site induration, Injection site rash, Irritability
Clinical narrative: Right anterior thigh red, raised, hard enlarging. Fever 99-100, cranky, decreased appetite. Rx KEFLEX 250/5ml oral suspension 1/2 tsp TID x10 days.
Age: 1.03
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Pyrexia
Clinical narrative: Right anterior thigh red, raised, hard enlarging. Fever 99-100, cranky, decreased appetite. Rx KEFLEX 250/5ml oral suspension 1/2 tsp TID x10 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash generalised
Clinical narrative: Patient had swelling & redness at injection site starting 8/30/12 then she developed a rash on her body 9/4/12.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased, Syncope
Clinical narrative: Syncope and collapse.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Vaccines given 9/5/12. Parent noted local reaction (L) arm site of DTaP and VARIVAX approximately 50mm soft, & tender, warm.
Age: 1.44
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: Red welts noted on arms & upper torso - reported via telephone by mother.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Injection site vesicles, Tenderness
Clinical narrative: There was an abnormal amount of redness, warmth & tenderness. There was also what appeared to be blisters at the injection site.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. got the ZOSTAVAX shot on 9/7/12. Immediately the site of injection started itching & turned pink. She called back on 9/8/12, saying site was swollen (size of an orange) and red. I told her to go to ER to have it checked.
Age: 19.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Arthralgia, Asthenia, Lymphadenopathy
Clinical narrative: Weakness, joint pain, adenopathy.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Malaise, Oedema peripheral, Skin warm
Clinical narrative: Red, swollen area that spread to elbow after vaccine. Hot to touch & patient did not feel well next day.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event yet. Nurse gave #3 VARIVAX after pt had documented 2 previous doses.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Contusion, Feeling abnormal, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Large dark bruise. Pain radiating from site of vaccine up to patient's head. Patient has fever, feels "off".
Age: 5.0
Sex: F
Vaccine: FLU3, HIBV, PNC
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None reported.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Urticaria
Clinical narrative: Admitted to hospital for severe rash (urticarial) & febrile illness.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness, warm to the touch - starting about 3 fingers from injection site middle of arm rotating to inner arm. Patient has never had a reaction to Flu
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site inflammation, Injection site rash, Oedema peripheral, Skin warm
Clinical narrative: Shot given 9/16/12 patient presented with hot, red swollen arm on 9/17/12 am. There are bumpy inflamed area around injection site - per pt.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Varicella
Clinical narrative: Swollen & red at injection site 9-7-12 gradually spread  & worse till made Dr appt 9-10-12, Dr diagnosed with chicken pox.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Two days after administration she developed a 5-8 inch red mark and her arm was warm, swollen & sore to touch. After 1 week it changed to a triangle red/puffy ~4 inch area. 10-11 days after, started to feel better, redness is starting to clear.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Administration site pain
Clinical narrative: Pain in site of administration for more than 1 week.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling with redness and swelling of right thigh. No purulent discharge was seen in emergency room and given KEFLEX. 4 days after area woke better. No fever, no systemic effects.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Parotitis
Clinical narrative: Acute parotitis developed 24-36 hours after FLUMIST no fever.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Bronchospasm, Cough, Pyrexia, Rash, Respiratory tract congestion
Clinical narrative: 7-17-12 Fever, coughing and congestion that started the evening of receiving vaccines. Bilateral high pitched wheezing that is mild, worse at lung bases. Fine rash on face and neck. Bronchospasm. Received 2 min bronchodilator nebulizer treatment with albuterol T 97.7, P 149, R 28, BP 96/58, O2 sat 98 RA.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Wheezing
Clinical narrative: 7-17-12 Fever, coughing and congestion that started the evening of receiving vaccines. Bilateral high pitched wheezing that is mild, worse at lung bases. Fine rash on face and neck. Bronchospasm. Received 2 min bronchodilator nebulizer treatment with albuterol T 97.7, P 149, R 28, BP 96/58, O2 sat 98 RA.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: ZOSTAVAX vaccine - rash & swelling with pain at injection site. Seeing MD on 9/17/12.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient stated that this years flu shot hurt immediately after administration. She called today (9/17/12) and states still very sore/painful. No visible redness or swelling ever occurred. Just very sore. TYLENOL suggested as needed.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Hyperhidrosis, Nausea, Oedema peripheral
Clinical narrative: Arm is swollen, red, warm to touch pt had sweating, chills, nausea and ached all over.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Skin warm
Clinical narrative: Arm is swollen, red, warm to touch pt had sweating, chills, nausea and ached all over.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Pruritus
Clinical narrative: Cold chills began Sat. after vaccination & patient noticed redness develop on Sunday. Itching was also observed by pt.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Musculoskeletal pain, Swollen tongue, Tongue disorder
Clinical narrative: None stated.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Red knots over all injection sites. Prescribed Mometasone Furoate 0.1% topical ointment to affected areas BID for 7-10 days.
Age: 40.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Middle insomnia, Pain
Clinical narrative: Within 3 to 5 hrs after receiving the FLUZONE vaccine, pt developed a round, red, raised, hard bump around injection site. Warm to touch. Localized to upper arm. Woke pt up in middle of night due to pain (about 8 on 1-10 scale). No fever, no rash elsewhere on body. No MD visit.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Adverse reaction, Injection site erythema, Injection site pain, Injection site pruritus, Injection site vesicles
Clinical narrative: Adverse rxn to ZOSTAVAX right arm. Patient developed redness at site of injection w/ a 4-5 inches in diameter w/ a few tiny blisters in the center. The affected site was itching and was tender to touch. No other symptoms were reported.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Pruritus, Rash, Rash pustular, Tenderness
Clinical narrative: Adverse rxn to ZOSTAVAX right arm. Patient developed redness at site of injection w/ a 4-5 inches in diameter w/ a few tiny blisters in the center. The affected site was itching and was tender to touch. No other symptoms were reported.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest pain, Condition aggravated, Dyspnoea, Hyperhidrosis
Clinical narrative: approx 10 min after FLUVIRIN dose pt c/o heart palpitation, diaphoresis, chest pain, difficulty breathing. Called 911, had pt sit down and try to relax. EMT arrived within 5-10 min. Pt claims she felt better but EMT evaluation concluded pt needed to be transported to the hospital. EMT Reported increased BP.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations
Clinical narrative: approx 10 min after FLUVIRIN dose pt c/o heart palpitation, diaphoresis, chest pain, difficulty breathing. Called 911, had pt sit down and try to relax. EMT arrived within 5-10 min. Pt claims she felt better but EMT evaluation concluded pt needed to be transported to the hospital. EMT Reported increased BP.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted and had potential seizure.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Inflammation, Pruritus
Clinical narrative: FLUZONE HD administered 9/12/12 3pm. At 2 am patient had difficulty breathing. Right arm was red, inflamed and itching at 9/14/12 4:15 pm (2 days later) when she came in. No breathing problem.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Developed chills, fever, swelling at injection site, was sick for 3 days following vaccine.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Mild chickenpox rash.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender who "three years ago" in approximately August 2009, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number not reported) and was in the office today, on 24-AUG-2012, to received the second dose of GARDASIL. No adverse effects were reported. Additional information is not expected.
Age: 21.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 21 years old patient who on 19-AUG-2008, was vaccinated with a dose of GARDASIL (dose, route and lot# not reported). The nurse stated that the patient might have received improperly stored GARDASIL. The nurse did not have the nature of the excursion because another facility sent the letter informing her of the incident. No adverse effect was reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a male patient of unknown age who on 12-AUG-2011, was vaccinated with the first dose of GARDASIL (route and lot# not reported). On 05-SEP-2012, the patient was vaccinated with the second dose of GARDASIL (route and lot# not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Dermatomyositis
Clinical narrative: Information has been received from a female patient with dermatomyositis which was symptomatic since November of 2011 who in February 2012, was vaccinated with a dose of GARDASIL (lot # not reported). In February 2012, the patient's dermatomyositis got worse since the vaccination. The patient had sought unspecified medical attention. Prednisone and PLAQUENIL were given to the patient as treatments. At the time of this report, the patient had not recovered. Follow-up information has been received from nurse practitioner. It was reported that the patient was currently being treated for a recent "diagnosis of dermatomyositis". It was reported that she was taking steroid and an immunosuppressants. It was reported that the patient did not feel that she had a reaction but that it was coincident. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope, Upper limb fracture
Clinical narrative: This spontaneous report as received from a physician refers to a current 13 years old female patient without pertinent medical history. The patient was vaccinated with 0.5 ml unspecified dose of GARDASIL (lot number not provided) in approximately September 2010, "2 years ago". No other co-suspects were reported. No concomitant medications were reported. In approximately September 2010, "2 years ago", when the patient was 11 years old, she was given GARDASIL, and afterwards she fainted, fell down and broke her elbow. She was sent to the ER but was not admitted. The patient had sought unspecified medical attention. Adverse events improved after stopping therapy. The outcome of broke her elbow, fainted and fell down was reported as recovered in approximately September 2010, "2 years ago". Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 14 years old male patient. The physician reported the patient "fainted for a few seconds" after administration of his first dose of GARDASIL (lot# was unknown) 2 months ago about in June, 2012. The patient sought medical attention in office and got no treatment. None lab diagnostics was performed. The patient fully recovered without requiring treatment. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Infectious mononucleosis
Clinical narrative: This spontaneous report as received from a health worker (medical assistant) refers to 19 years old female patient. The patient's medical history included mononucleosis. On 08-MAY-2012, the patient was vaccinated with dose 2 GARDASIL. Lot number and the dosage regimen was unspecified. No concomitant medications were reported. Approximately in August or September 2012 (reported as last week), the patient experienced mononucleosis. The patient sought medical attention and was seen in the office. Last week, the patient was treated with an unspecified antibiotic for the same, but was now discontinued. The outcome of mononucleosis was reported as recovered/resolved and the patient was fine. Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Pallor
Clinical narrative: This spontaneous report as received from a physician refers to a 8 weeks old male patient with pertinent medical history of GERD and with no drug reactions/allergies. The patient was vaccinated with ROTATEQ (Lot# reported as 1807A17, orally, dose was unspecified) on 12-JUL-2012. No other co-suspects were reported. Concomitant medications included DTaP, IPV, PEDVAXHIB, PREVNAR 13, ZANTAC, deglycyrrhizinated licorice and PROBIOTICA. The physician stated the patient's parents reported the patient "turn extremely pale for 20-40 minutes three times in a 24 hour period" on 12-JUL-2012 after receiving ROTATEQ. The patient had sought medical attention via phone call. No lab diagnostics studies performed and no treatment was given for the adverse events. The outcome was reported as recovered/resolved (date unspecified). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (Lot # unspecified) in 2011 and the second dose (Lot # unspecified) on 11-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant. Medical assistant reported that there had been some patients who received second dose of GARDASIL (Lot# unspecified) outside of recommended schedule in the past (dates unspecified). No concomitant medications were reported. Specific number of patients unspecified. No adverse effect reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain upper, Inappropriate schedule of drug administration, Maternal exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a laboratory technician, for GARDASIL a pregnancy registry product, concerning an 18 years old female patient. The patient's history of previous pregnancies and live births is not known. The reporter stated that the patient received her GARDASIL intramuscular series doses on the following dates 19-JUN-2008, 11-SEP-2008 and 29-AUG-2012 (lot # 672652/0022AE, exp 30-SEP-20140). After the patient received her third dose of GARDASIL yesterday on 29-AUG-2012, the patient informed the physician that she was pregnant. The patients last menstrual period LMP was 15-JUN-2012 and EDD was 22-MAR-2013. The reporter stated that at the time of the administration of the third dose of GARDASIL (lot # 672652/0022AE, exp 30-SEP-2014). The practice's computer system was not functioning, so the fact that the patients pregnant was not considered prior to administration of the dose of GARDASIL. The dose of GARDASIL was administered concomitantly with MENACTRA and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufactures unspecified). The patient had consulted the physician because she was experiencing "stomach pain after eating spicy foods" (approximately in August 2012). The reporter was not aware if any treatment was given for the adverse experience. Initial exposure to GARDASIL was at 0 week. The patient was exposed to GARDASIL during trimester 1. The outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Menstruation irregular
Clinical narrative: Information has been received from a consumer regarding her daughter of unknown age. There was no medical history reported. In 2007, the patient was vaccinated with 0.5 mL of the first dose of GARDASIL intramuscular. In 2010, the patient was vaccinated with 0.5 mL of the second dose of GARDASIL intramuscular. In 2012, the patient was vaccinated with 0.5 mL of the third dose of GARDASIL intramuscular. No other co-suspects were reported. No concomitant medications were reported. The patient had irregular periods after her first shot with GARDASIL in 2007 and had a loss of period after her second dose of GARDASIL in 2010. The patient did not received treatment for the adverse event. No laboratory tests were performed. The patient's outcome was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient was vaccinated with GARDASIL on an unspecified date. On an unknown date the patient experienced hives. The outcome of the hives was not reported. This is one of several reports from the same source. Additional information is not expected.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 77 years old male patient with none drug reactions/allergies. The patient's medical history included hypertension. The patient was vaccinated with 0.65 ml ZOSTAVAX (SQ, left arm) (lot#1658AA) as reported, exp date:21-JAN-2013) on 17-MAY-2012. Concomitant medications included unspecified medication for hypertension. On 19-MAY-2012 two days after receiving ZOSTAVAX. The patient experienced shingles. The patient visited to unspecified physician's office and was treated with ZOVIRAX. The outcome of shingles was reported as recovered/resolved on an unspecified date. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse reporting that at her office immunocompetent patients were revaccinated with PNEUMOVAX 23 (doses and lot numbers not reported) every 5 years. The numbers of patients involved were unspecified. There were no symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age. The patient was inadvertently administered VARIVAX (1 dose from vial, Subcutaneous, lot # not reported) instead of ZOSTAVAX on 29-AUG-2012. No adverse effect reported. No other co-suspects were reported. No concomitant medications were reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age. On 21-AUG-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # 671780/0170AE, exp. date 13-JUN-2013). It was reported that the diluent for ZOSTAVAX was frozen inadvertently was used to reconstitute ZOSTAVAX. The reporter could not provide temperature reading of the freezer in which diluents were kept and stability of diluents could not be determined. It was unknown if the patient sought medical attention or not. No adverse effect reported. Additional information has been requested.