chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Erythema, Injection site pain, Injection site pruritus, Skin warm, Tenderness
Clinical narrative: Case number PHHY2011US86844 is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 427175) website on 30 Sep 2011: This report refers to a 17-year-old female patient. Concomitant medications included birth control medicines. She was vaccinated with MENVEO (batch number: M10049) intramuscularly in to the left arm on 05 Jul 2011. On the same day she noticed reaction to left upper arm which was described as itchy and painful, with six to seven cm of erythema, slight warmth, and slight tenderness and was very sharply demarcated. The reaction was treated with BENADRYL, one tablet of BACTRIM DS twice daily taken orally and topical steroid. The outcome was reported as complete recovery of the patient on an undetermined date.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Case number PHHY2011US86844 is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 427175) website on 30 Sep 2011: This report refers to a 17-year-old female patient. Concomitant medications included birth control medicines. She was vaccinated with MENVEO (batch number: M10049) intramuscularly in to the left arm on 05 Jul 2011. On the same day she noticed reaction to left upper arm which was described as itchy and painful, with six to seven cm of erythema, slight warmth, and slight tenderness and was very sharply demarcated. The reaction was treated with BENADRYL, one tablet of BACTRIM DS twice daily taken orally and topical steroid. The outcome was reported as complete recovery of the patient on an undetermined date.
Age: 51.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Erythema, Headache, Local reaction, Pyrexia, Swelling
Clinical narrative: Case number PHHY2011US87160 is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 427508) website on 30 Sep 2011: This report refers to a 51 year old female patient. She was vaccinated with MENVEO (batch number: A10051 and expiry date: Jan 2013) in the left arm on 13 Jul 2011. On the same day after vaccination the patient experienced high fever 101.0 to 103.2 F, with headache, and local reaction with swelling and minimal redness. The patient required medical attention (ER visit). The patient recovered completely on unspecified date.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Erythema, Skin warm, Syncope, Tenderness
Clinical narrative: Case number PHEH2011US86849 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS; reference number 427984) on 30 Sep 2011: This report refers to a 17-year-old female patient. She was vaccinated with MENVEO (batch number: 10053) intramuscularly into the right arm and with TDAP (batch number: C3927AA, other manufacturer) intramuscularly into the left arm on 20 Jul 2011. On the same day after vaccination, she developed redness on right arm. The right arm was red, hot and tender but no pruritus was present. On 21 Jul 2011, she fainted. She recovered completely from the events.
Age: 19.0
Sex: M
Vaccine: HEP, HEPA, MNQ, HEP, HEPA, MNQ
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Case number PHHY2011US86896 is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 428380) website on 30 Sep 2011: This report refers to a 19-year-old male patient. He received MENVEO (batch number A10059) on 26 Jul 2011. He also received hepatitis vaccine (batch number AHBVB832BB, other manufacturer) and hepatitis A vaccine (batch number AHAVB518BA, other manufacturer) into right arm. But MenA component of MENVEO was mixed with the wrong sterile diluent (batch number G00151, expiry date Mar 2012, other manufacturer) instead of the correct liquid conjugate component for the MENVEO. No adverse event reported.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Local reaction
Clinical narrative: Case number PHHY2011US86902 is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 428416) website on 30 Sep 2011: This report refers to 11-year-old male child. Medical history included allergy to CEFTIN and attention deficient hyperactivity disorder (ADHD). He was vaccinated with MENVEO (batch number A10053) into right arm and on 27 Jun 2011. He was also vaccinated with Tdap (batch number ACB071BB) into left arm. After vaccination with MENVEO on 28 Jul 2011, he started having large local reaction around the site. Area was red, indurated, and pruritic. Total diameter was about 15-18cm. He was given steroid and told to use cold compresses and BENADRYL.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Dizziness, Gaze palsy, Loss of consciousness, Pallor, Syncope
Clinical narrative: Case number PHHY2011US86908, is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS ID; 428556) on 30 Sep 2011: This case refers to a 11-year-old male child. He was vaccinated with MENVEO (batch number M10030), intramuscularly into right arm and TDAP (batch number AC52B066AA, other manufacturer), intramuscularly into left arm on 01 Aug 2011. The child was quiet and sitting down when he received vaccines. Approximately one minute later, the child stood up and was walking to the door when his head shook once and his eyes rolled back and he turned pale and fainted. He was caught by his mother and did not hit his head or any other part of his body. He was eased to laying position. He woke up after 5-7 seconds and was talking regular. He said he felt dizzy right before he passed out. His color returned after approximately one minute and he continued to rest on floor for about five minutes. After ten minutes, he felt much better. Outcome of the event was reported as complete recovery.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Tremor
Clinical narrative: Case number PHHY2011US86908, is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS ID; 428556) on 30 Sep 2011: This case refers to a 11-year-old male child. He was vaccinated with MENVEO (batch number M10030), intramuscularly into right arm and TDAP (batch number AC52B066AA, other manufacturer), intramuscularly into left arm on 01 Aug 2011. The child was quiet and sitting down when he received vaccines. Approximately one minute later, the child stood up and was walking to the door when his head shook once and his eyes rolled back and he turned pale and fainted. He was caught by his mother and did not hit his head or any other part of his body. He was eased to laying position. He woke up after 5-7 seconds and was talking regular. He said he felt dizzy right before he passed out. His color returned after approximately one minute and he continued to rest on floor for about five minutes. After ten minutes, he felt much better. Outcome of the event was reported as complete recovery.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Dizziness, Gaze palsy, Head titubation, Pallor, Syncope
Clinical narrative: Case number PHHY2011US86908, is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS ID; 428556) on 30 Sep 2011: This case refers to a 11-year-old male child. He was vaccinated with MENVEO (batch number M10030), intramuscularly into right arm and TDAP (batch number AC52B066AA, other manufacturer), intramuscularly into left arm on 01 Aug 2011. The child was quiet and sitting down when he received vaccines. Approximately one minute later, the child stood up and was walking to the door when his head shook once and his eyes rolled back and he turned pale and fainted. He was caught by his mother and did not hit his head or any other part of his body. He was eased to laying position. He woke up after 5-7 seconds and was talking regular. He said he felt dizzy right before he passed out. His color returned after approximately one minute and he continued to rest on floor for about five minutes. After ten minutes, he felt much better. Outcome of the event was reported as complete recovery.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Chest pain, Dyspnoea, Headache, Injection site erythema, Injection site pain
Clinical narrative: Case number PHHY2011US87690, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System website (VAERS ID; 428594) on 30 Sep 2011: This report refers to 12-year-old male patient. He was vaccinated with MENVEO (batch number A10051)), into left arm on 19 Jul 2011. Next day on 20 Jul 2011, the patient came with symptoms of unable to breathe, chest pain, nausea, headache, low grade temp and achy. He experienced redness, swelling and tenderness at injection site. Outcome of the event was recovery as of unknown date. Following an internal review done on 22 Nov 2011 for the data received on 30 Sep 2011 following case correction done: Event low grade temperature was wrongly coded to body temperature increased which was corrected to body temperature decreased.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: Case number PHHY2011US87690, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System website (VAERS ID; 428594) on 30 Sep 2011: This report refers to 12-year-old male patient. He was vaccinated with MENVEO (batch number A10051)), into left arm on 19 Jul 2011. Next day on 20 Jul 2011, the patient came with symptoms of unable to breathe, chest pain, nausea, headache, low grade temp and achy. He experienced redness, swelling and tenderness at injection site. Outcome of the event was recovery as of unknown date. Following an internal review done on 22 Nov 2011 for the data received on 30 Sep 2011 following case correction done: Event low grade temperature was wrongly coded to body temperature increased which was corrected to body temperature decreased.
Age: 17.0
Sex: U
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Headache, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2011US87158 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS ID: 429459) on 30 Sep 2011. This report refers to a 17 year old patient. The patient did not have any pre-existing conditions and concomitant medications. The patient was vaccinated with MENVEO (batch number: 100004) intramuscularly in the left arm, and ADACEL (manufactured by Sanofi, batch number: U4088AA) intramuscularly in the left arm on 06 Aug 2011. On 07 Aug 2011, the patient experienced dizziness, nausea, fever, vomiting, shortness of breath (SOB), and heavy chest. The patient went to an emergency room (ER). On 08 Aug 2011, the patient again went to emergency room with complaints of stiff neck and massive headache. The outcome was reported as "not yet recovered".
Age: 17.0
Sex: U
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2011US87158 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS ID: 429459) on 30 Sep 2011. This report refers to a 17 year old patient. The patient did not have any pre-existing conditions and concomitant medications. The patient was vaccinated with MENVEO (batch number: 100004) intramuscularly in the left arm, and ADACEL (manufactured by Sanofi, batch number: U4088AA) intramuscularly in the left arm on 06 Aug 2011. On 07 Aug 2011, the patient experienced dizziness, nausea, fever, vomiting, shortness of breath (SOB), and heavy chest. The patient went to an emergency room (ER). On 08 Aug 2011, the patient again went to emergency room with complaints of stiff neck and massive headache. The outcome was reported as "not yet recovered".
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Grand mal convulsion, Metabolic function test, Nuclear magnetic resonance imaging brain
Clinical narrative: Case number PHHY2011US94896 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS Ref: 430135) website on 27 Oct 2011 with a follow-up received from the product technical complaint department (PTC reference number: 132955) on 09 Nov 2011. This report refers to a 12 year old male patient. He was healthy child. He was vaccinated with MENVEO (batch number: A10051) intramuscularly in the left arm on 11 Aug 2011. The patient developed GTC seizure (generalized tonic-clonic seizure) with uncertain etiology on 17Aug 2011. The patient required emergency medical attention. A basic metabolic panel and a brain MRI were done. However, the results were not reported. The outcome was reported as complete recovery. Non significant follow-up received from the product technical complaint department (PTC reference number: 132955) on 09 Nov 2011: Updated reference number.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site pain, Screaming, Seizure like phenomena
Clinical narrative: This is a spontaneous report from a contactable physician. A 1-month-old male patient received the first dose of PREVNAR 13, intramuscularly, in the left thigh, on 07Jul2011, for the prevention of pneumonia. On this same date, the patient was also administered the first doses of PENTACEL, Hepatitis B vaccine and ROTATEQ. Relevant history included "murmur". Concomitant medications and past product history were not provided. On 07Jul2011, following administration of the vaccinations, the patient developed a low grade fever, crying and loose stools. On 08Jul2011, as a result of the events, the patient was seen by the physician. The outcome of the events was not reported. Follow-up (24Oct2011): Follow-up attempts completed. No further information expected.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Diarrhoea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician. A 1-month-old male patient received the first dose of PREVNAR 13, intramuscularly, in the left thigh, on 07Jul2011, for the prevention of pneumonia. On this same date, the patient was also administered the first doses of PENTACEL, Hepatitis B vaccine and ROTATEQ. Relevant history included "murmur". Concomitant medications and past product history were not provided. On 07Jul2011, following administration of the vaccinations, the patient developed a low grade fever, crying and loose stools. On 08Jul2011, as a result of the events, the patient was seen by the physician. The outcome of the events was not reported. Follow-up (24Oct2011): Follow-up attempts completed. No further information expected.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2011US94890 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 430448) website on 27 Oct 2011. This report refers to a 13-year old male patient. The patient was vaccinated with MENVEO (batch number: A10057) intramuscularly on left arm, HAVRIX (manufactured by GlaxoSmithKline, batch number: AHAVB408AA) intramuscularly on right arm and VARIVAX (manufactured by Merck, batch number: 1321Y) subcutaneously on right arm and GARDASIL (manufactured by Merck, batch number: 0337Z) intramuscularly on left arm on 15 Aug 2011. On 16 Aug 2011, the patient experienced red rash at injection site. The patient also had swelling and it was warm to touch at the injection site. The patient was taken to the emergency room. The outcome was reported as complete recovery at the time of reporting (19 Aug 2011).
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Erythema, Induration
Clinical narrative: Case number PHHY2011US94828 is an initial spontaneous report received from Vaccine Adverse Event Reporting System  (VAERS reference number: 430753) website on 27 Oct 2011. This report refers to a 16-year old female patient. This patient was vaccinated with MENVEO (batch number: A10053) intramuscularly on left arm on 30 Jul 2011. It was reported that the patient experienced induration; and erythema of the arm after 36 hours of injection. The patient was taken to the emergency room. The outcome was reported as complete recovery at the time of reporting (17 Aug 2011).
Age: 20.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2011US94806 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 430815) website on 27 Oct 2011. This report refers to a 20-year old female patient. This patient was vaccinated with MENVEO (batch number: M10047) intramuscularly on left arm on 17 Aug 2011. On 18 Aug 2011, the patient experienced injection site swelling, itching and redness spread to the entire upper arm. The outcome was reported as condition unchanged at the time of reporting (19 Aug 2011).
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Fatigue, Headache, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Case number PHHY2011US94754 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 430970) website on 27 Oct 2011. This report refers to a 16-year-old female patient. Her medical history included rash due to penicillin and her concomitant medications included AVIANE birth control pills. She was vaccinated with MENVEO (batch number: A10059) into the left arm and with BOOSTRIX (other manufacturer and batch number: AC52B071CA) into the right arm on 09 Aug 2011. On 10 Aug 2011 she presented with low grade fever, headache, fatigue, sore throat and nausea. She was taking MOTRIN prn as a corrective treatment for the events. The outcome was reported as condition unchanged at the time of reporting.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Body temperature increased, Hypophagia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2011US94749 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 431027) website on 27 Oct 2011. This report refers to a 17-year-old female patient. Her medical history included kidney stones, asthma, sinusitis and scoliosis and her concomitant medications involved multivitamin and DEPO PROVERA. She was vaccinated with MENVEO vaccines (batch number: 091201) into the left arm on 04 Aug 2011. On 05 Aug 2011 she had red, tender, swollen area at injection site and had oral temperature of 103.5 degrees Fahrenheit that would not go down with MOTRIN, ATARAX had been given to her by her mother, she was sleepy, not eating, not drinking so her mother took her to emergency room (ER) that night. Patient went home that night. On 08 Aug 2011 she had no fever and felt better but her arm was still tender and red. On 07 Aug 2011 she recovered from redness and swelling also. Final outcome was reported as complete recovery and the patient was doing well.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Somnolence
Clinical narrative: Case number PHHY2011US94749 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 431027) website on 27 Oct 2011. This report refers to a 17-year-old female patient. Her medical history included kidney stones, asthma, sinusitis and scoliosis and her concomitant medications involved multivitamin and DEPO PROVERA. She was vaccinated with MENVEO vaccines (batch number: 091201) into the left arm on 04 Aug 2011. On 05 Aug 2011 she had red, tender, swollen area at injection site and had oral temperature of 103.5 degrees Fahrenheit that would not go down with MOTRIN, ATARAX had been given to her by her mother, she was sleepy, not eating, not drinking so her mother took her to emergency room (ER) that night. Patient went home that night. On 08 Aug 2011 she had no fever and felt better but her arm was still tender and red. On 07 Aug 2011 she recovered from redness and swelling also. Final outcome was reported as complete recovery and the patient was doing well.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Nodule, Oedema peripheral
Clinical narrative: Case number PHHY2011US94735 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 431126) website on 27 Oct 2011. This report refers to a 11-year-old female patient. She was vaccinated with MENVEO (batch number: M10032) intramuscularly into the right arm, with ADACEL (other manufacturer and batch number: U3111BA) intramuscularly into the left arm and with VARIVAX (other manufacturer and batch number: 1701Z) subcutaneously into the left arm on 03 Aug 2011. On 04 Aug 2011 she experienced left arm knot and edema of arm but had no fevers. Mother administered TYLENOL and iced the affected area. Outcome was reported as complete recovery on an undetermined date.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Abdominal pain upper, Pain
Clinical narrative: Case number PHHY2011US95104 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 431140) website on 27 Oct 2011. This report refers to a 14 year old male patient. He was vaccinated with MENVEO (batch number: A10061) in the left arm on 12 Aug 2011. The patient developed stomach ache and body aches on 13 Aug 2011. The patient recovered completely by 15 Aug 2011.
Age: 13.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2011US95099 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 431154) website on 27 Oct 2011. This report refers to a 13 year old female patient. She was vaccinated with MENVEO (batch number: A10098) intramuscularly in the left arm on 16 Aug 2011. The patient developed headache, nausea, fever (temperature 102 F) and she also vomited 2-3 times on 17 Aug 2011 afternoon. The patient's fever persisted at 102 F on 18 Aug 201. She was treated with MOTRIN for the fever and fever resolved. The patient recovered completely on 18 Aug 2011 afternoon.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2011US95100 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 431213) website on 27 Oct 2011. This report refers to a 12 year old female patient. She was vaccinated with MENVEO (batch number: M10031) intramuscularly in the left arm, ADACEL (manufactured by Sanofi, batch number: U3486CA) also intramuscularly in the left arm, and GARDASIL (manufactured by Merck, batch number: 0841AA) intramuscularly in the right arm on 23 Aug 2011. On the same day, the patient's left arm became red, swollen, warm and painful where ADACEL and MENVEO were given. The patient was taken to emergency room. The outcome was reported as not yet recovered at the time of reporting (25 Aug 2011).
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Case number PHHY2011US87156 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS ID: 431353) on 30 Sep 2011. This report refers to a 12 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number unknown) in the left arm, GARDASIL (batch number 666929/0331Z, expiry date: Nov 2012) intramuscularly in the left deltoid, VARIVAX (batch number: 667237/1357Z) subcutaneously in the left deltoid and HAVRIX (batch number: unknown) in the right arm on 07 Mar 2011. The patient experienced injection site reaction which was described as tender, raised (swelling), red area (10 cm in diameter) at the left arm. The patient was treated with ice packs, MOTRIN and BENADRYL. The patient did not seek any medical attention. The patient recovered on unspecified date. All the four vaccines were suspected to cause the reactions.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2011US87156 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS ID: 431353) on 30 Sep 2011. This report refers to a 12 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number unknown) in the left arm, GARDASIL (batch number 666929/0331Z, expiry date: Nov 2012) intramuscularly in the left deltoid, VARIVAX (batch number: 667237/1357Z) subcutaneously in the left deltoid and HAVRIX (batch number: unknown) in the right arm on 07 Mar 2011. The patient experienced injection site reaction which was described as tender, raised (swelling), red area (10 cm in diameter) at the left arm. The patient was treated with ice packs, MOTRIN and BENADRYL. The patient did not seek any medical attention. The patient recovered on unspecified date. All the four vaccines were suspected to cause the reactions.
Age: 14.0
Sex: U
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Case number PHHY2011US95094 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 431673) website on 27 Oct 2011. This report refers to a 14-year-old patient of unknown gender. This patient was vaccinated with MENVEO (batch number: A10033) intramuscularly on 08 Aug 2011. On the same day after vaccination this patient developed edema, erythema and pruritus at the injection site/ There was no shortness of breath, pain or dizziness. No trouble with vision senses. The events were treated with BENADRYL, ice pack and TYLENOL. Final outcome was reported as complete recovery of the patient on an unknown date.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, DTAP, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2011US95049 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 431885) website on 27 Oct 2011. This report refers to a 12-year-old female patient. This patient was vaccinated with MENVEO (batch number: X10053) intramuscularly on left arm, DTAP (batch number: AC52B072AA) intramuscularly on right arm and VARCEL (batch number: 0034AA8) subcutaneously on left arm on 22 Aug 2011. On 23 Aug 2011, the patient experienced redness and swelling at site of injection. The next day the redness increased in size (10cm x 6.5cm). The outcome was reported as complete recovery at the time of reporting (29 Aug 2011).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, DTAP, MNQ, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Case number PHHY2011US95045 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 431984) website on 27 Oct 2011. This report refers to an 11-year-old male patient. His concomitant medication included PROACTIV. He was vaccinated with MENVEO (batch number: A10062) intramuscularly on right arm, DTAP (batch number: AC52B071CA) intramuscularly on left arm and VARCEL (batch number: E008758) subcutaneously on left arm on 25 Aug 2011. On 26 Aug 2011, it was reported that the patient's arm became red, swollen and was warm to touch. Patient was treated with BENADRYL and cool compresses. The outcome was reported as condition unchanged at the time of reporting (29 Aug 2011).
Age: 11.0
Sex: F
Vaccine: HPV4, DTP, HPV4, MNQ
Symptoms: Blood test, Hypoaesthesia, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Case number PHHY2011US95027 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 432337) website on 27 Oct 2011. This report refers to an 11-year-old female patient. The patient's medical history included asthma, gastrooesophageal reflux disease and anxiety disorder. She was vaccinated with MENVEO (batch number: not specified) on 17 Dec 2010. She was also vaccinated with GARDASIL (batch number: not specified) and DTP (batch number: not specified and manufacturer unknown) on 17 Dec 2010. On 19 Dec 2010, the patient experienced numbness and pain in both legs. The patient was examined in the emergency room on 19 Dec 2010, but not admitted. On 20 Dec 2010, the patient saw the nurse practitioner at the office. The patient was followed up by neurology for about a month. The patient was not given treatment. Blood tests and an MRI performed with unspecified results. The event outcome was reported as complete recovery at the time of reporting (04 Aug 2011).
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, FLUN3, HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Case number PHHY2011US95015 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 432575) website on 27 Oct 2011. This report refers to a 11 year old female patient. She was vaccinated with MENVEO (batch number: A10028) intramuscularly in the right arm, intranasal FLUMIST  (manufactured by MedImmune, batch number: 501103P) intra-nasally, human papilloma virus vaccine (manufactured by Merck, batch number: 0180AA) intramuscularly in the right arm, and tetanus, diphtheria and acellular pertussis vaccine (manufactured by sanofi, batch number: C3490AA) also intramuscularly in the right arm on 31 Aug 2011. The patient experienced hives after vaccination, on the same day evening. She was prescribed BENADRYL and she recovered completely by next morning.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Case number PHHY2011US95012 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 432633) website on 27 Oct 2011 and following internal review on 16 Nov 2011 of the data received on 27 Oct 2011. This report refers to 11 year old female patient. She was vaccinated with MENVEO (batch number: A10057) intramuscularly in the right arm, TDAP (manufacturer by GlaxoSmithKline, batch number: AC52B072AA) intramuscularly in the left arm and VARIVAX (batch number: 0463AA) subcutaneously in the right arm in 16 Aug 2011. After vaccination the patient experienced itching at the vaccination site of MENVEO, VARIVAX and TDAP on the same day. On 17 Aug 2011, the patient experienced raised and red area (3/4 inch x 1/2 inch) to the right upper arm at MENVEO site, raised patch and lesion at VARIVAX vaccination area (2 inch x 2.5 inch) and red raised lesion at TDAP vaccination site (1 inch x 1 inch). The outcome was reported as not yet recovered at the time of reporting (17 Aug 2011). Following internal review on 16 Nov 2011, of the data received on 27 Oct 2011 following correction was done: The event "skin lesion" was assessed as unlisted (wrongly assessed as listed previously).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: Case number PHHY2011US95012 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 432633) website on 27 Oct 2011 and following internal review on 16 Nov 2011 of the data received on 27 Oct 2011. This report refers to 11 year old female patient. She was vaccinated with MENVEO (batch number: A10057) intramuscularly in the right arm, TDAP (manufacturer by GlaxoSmithKline, batch number: AC52B072AA) intramuscularly in the left arm and VARIVAX (batch number: 0463AA) subcutaneously in the right arm in 16 Aug 2011. After vaccination the patient experienced itching at the vaccination site of MENVEO, VARIVAX and TDAP on the same day. On 17 Aug 2011, the patient experienced raised and red area (3/4 inch x 1/2 inch) to the right upper arm at MENVEO site, raised patch and lesion at VARIVAX vaccination area (2 inch x 2.5 inch) and red raised lesion at TDAP vaccination site (1 inch x 1 inch). The outcome was reported as not yet recovered at the time of reporting (17 Aug 2011). Following internal review on 16 Nov 2011, of the data received on 27 Oct 2011 following correction was done: The event "skin lesion" was assessed as unlisted (wrongly assessed as listed previously).
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL, HEPA, MNQ, VARCEL
Symptoms: Induration, Oedema peripheral
Clinical narrative: Case number PHHY2011US95008 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 432686) website on 27 Oct 2011. This report refers to a 11 year old female patient. She was vaccinated with MENVEO (batch number: A10047) intramuscularly in the right arm, hepatitis A vaccine (manufactured by GlaxoSmithKline, batch number: E008684) intramuscularly in the left arm on 30 Aug 2011. The patient experienced swelling and induration of right lateral arm on 31 Aug 2011. She recovered completely on unspecified date.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site papule, Papule
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner communicated to a Pfizer sales representative. A 2-month-old infant received a dose of PREVNAR 13, the first dose of PENTACEL and the second dose of Hepatitis B via an intramuscular route of administration in the left arterial thigh, and ROTATEQ via an oral route of administration on 17Aug2011. Relevant medical history was none. No concomitant medications were provided and past product history included one prior Hepatitis B vaccination with no adverse reaction. The patient experienced rash-fine red papules on 20Aug2011. The patient sought follow-up care at the nurse's office. The patient recovered 25Aug2011. The nurse believes there is a reasonable possibility that the event is related to PREVNAR 13. The patient did provide information regarding the reported adverse event with the use of the product. The nurse can confirm the occurrence of the event reported by the patient. Follow-up (14Oct2011): New information was received from a contactable nurse provided patient demographics, product details, medical and past product history details, updated event term, and event outcome. Follow-up attempts completed. No further information expected.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash papular
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner communicated to a Pfizer sales representative. A 2-month-old infant received a dose of PREVNAR 13, the first dose of PENTACEL and the second dose of Hepatitis B via an intramuscular route of administration in the left arterial thigh, and ROTATEQ via an oral route of administration on 17Aug2011. Relevant medical history was none. No concomitant medications were provided and past product history included one prior Hepatitis B vaccination with no adverse reaction. The patient experienced rash-fine red papules on 20Aug2011. The patient sought follow-up care at the nurse's office. The patient recovered 25Aug2011. The nurse believes there is a reasonable possibility that the event is related to PREVNAR 13. The patient did provide information regarding the reported adverse event with the use of the product. The nurse can confirm the occurrence of the event reported by the patient. Follow-up (14Oct2011): New information was received from a contactable nurse provided patient demographics, product details, medical and past product history details, updated event term, and event outcome. Follow-up attempts completed. No further information expected.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Syncope
Clinical narrative: Case number PHHY2011US94967 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS ref: 433508) website on 27 Oct 2011. This report refers to 13- year-old female patient. Her concomitant medication included PPD (tuberculin). She was vaccinated with MENVEO (batch number: A10058) intramuscularly into right arm on 25 Aug 2011 and also vaccinated with Hepatitis A vaccine (other manufacturer, batch number: 0984AA) intramuscularly into left arm on 25 Aug 2011. Few minutes later of vaccination she experienced fainting episode. The event outcome reported as recovered.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV2, MNQ, TDAP, VARCEL, HEPA, HPV2, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Headache, Hypersensitivity, Nausea, Rash generalised
Clinical narrative: Case number PHHY2011US94831 is an initial spontaneous report derived from the Vaccine Adverse Event Reporting System website (VAERS reference number: 434220) on 27 Oct 2011. This case refers to an 18-year-old female patient. Her medical history include allergy to acetaminophen, acetylsalicylic acid and penicillin. On 22 Jun 2011, she was vaccinated with MENVEO (batch number: M10047) intramuscularly into her left arm, VAQTA (other manufacturer, batch number: 0368AA) intramuscularly into her left arm, CERVARIX (other manufacturer, batch number: AHPV096AC) intramuscularly, ADACEL (batch number: M3491CA) intramuscularly into her right arm, and VARIVAX (other manufacturer, batch number: 0044AA) intramuscularly. On the same day she experienced allergic reaction in both eye, rash all over, weakness, nausea, headache and swelling. The outcome of these events was reported as not recovered.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV2, MNQ, TDAP, VARCEL, HEPA, HPV2, MNQ, TDAP, VARCEL
Symptoms: Swelling
Clinical narrative: Case number PHHY2011US94831 is an initial spontaneous report derived from the Vaccine Adverse Event Reporting System website (VAERS reference number: 434220) on 27 Oct 2011. This case refers to an 18-year-old female patient. Her medical history include allergy to acetaminophen, acetylsalicylic acid and penicillin. On 22 Jun 2011, she was vaccinated with MENVEO (batch number: M10047) intramuscularly into her left arm, VAQTA (other manufacturer, batch number: 0368AA) intramuscularly into her left arm, CERVARIX (other manufacturer, batch number: AHPV096AC) intramuscularly, ADACEL (batch number: M3491CA) intramuscularly into her right arm, and VARIVAX (other manufacturer, batch number: 0044AA) intramuscularly. On the same day she experienced allergic reaction in both eye, rash all over, weakness, nausea, headache and swelling. The outcome of these events was reported as not recovered.
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Pruritus, Rash macular
Clinical narrative: Case number PHHY2011US94799 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 434289) website on 27 Oct 2011. This report refers to an 11-year-old female patient. This patient was vaccinated with MENVEO (batch number: M10051) intramuscularly, site unspecified on 12 Sep 2011. On 13 Sep 2011, it was reported that she experienced red itchy splotches in face area. Patient denied shortness of breath, trouble breathing or swelling in throat and nose area. The patient was given BENADRYL and it seemed to help. The outcome was reported as condition unchanged at the time of reporting (13 Sep 2011).
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: Case number PHHY2011US94799 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 434289) website on 27 Oct 2011. This report refers to an 11-year-old female patient. This patient was vaccinated with MENVEO (batch number: M10051) intramuscularly, site unspecified on 12 Sep 2011. On 13 Sep 2011, it was reported that she experienced red itchy splotches in face area. Patient denied shortness of breath, trouble breathing or swelling in throat and nose area. The patient was given BENADRYL and it seemed to help. The outcome was reported as condition unchanged at the time of reporting (13 Sep 2011).
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13
Symptoms: Crying, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician. A male infant received a dose of PREVNAR 13, along with a dose of PENTACEL, on an unspecified date. Relevant medical history, concomitant medications and past product history were not provided. On 12Sep2011, at the age of 3 months, the patient developed a swollen left thigh at the site of PENTACEL injection. The outcome of the event at the time of the report was unknown.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician. A male infant received a dose of PREVNAR 13, along with a dose of PENTACEL, on an unspecified date. Relevant medical history, concomitant medications and past product history were not provided. On 12Sep2011, at the age of 3 months, the patient developed a swollen left thigh at the site of PENTACEL injection. The outcome of the event at the time of the report was unknown.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Incorrect dose administered, No adverse event, Restlessness
Clinical narrative: My 2 month old was given a double dose of the vaccine DTaP. My son seems ok as of right now. No Fever, he is unsettled.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Disability, Mobility decreased, Myalgia, Tendon disorder
Clinical narrative: Severe muscle pain, loss of use of upper arm, inability to complete normal tasks, disability continues, sought medical care in December. Rotator cuff tendonosis and biceptical tendonitis. 4 week of therapy ahead.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Tendonitis
Clinical narrative: Severe muscle pain, loss of use of upper arm, inability to complete normal tasks, disability continues, sought medical care in December. Rotator cuff tendonosis and biceptical tendonitis. 4 week of therapy ahead.
Age: 19.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Injection site pain, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: Pt returned to office 2 days following vaccination. Reported feeling pain & swelling at site of PNEUMOVAX injection. At office visit physician noted (R) deltoid swollen & warm. No redness, no papules. Enlarged (R) cervical chain. Temp 100.7. Tx BENADRYL, Ibuprofen, ice.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Antibiotic resistant Staphylococcus test negative, Blood culture negative, Blood immunoglobulin A normal, Blood immunoglobulin E increased, Blood immunoglobulin G normal
Clinical narrative: This is an spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 3-year-old child (gender unknown) received a dose of PREVNAR 13 (Lot E 87534) on an unspecified date. Relevant medical history included viral URI immediately prior to onset pneumonia. Concomitant vaccines included Influenza virus vaccine and Hep A. Past product history included dose one of PREVNAR on 14Jan2009, 2nd dose on 17Mar2009, 3rd dose on 12May2009 and 4th dose on 03Dec2009; the 1st dose of DTaP on 14Jan2009, 2nd dose on 15Apr2009, 3rd dose on 12May2009, 4th dose on 16Feb2010; the 1st dose of Hib on 14Jan2009, 2nd dose on 17Mar2009 and 3rd dose on 03Dec2009; 1st dose of IPV on 13Aug2009, 2nd dose on 16Feb2010, and 3rd dose on 26Jun2010; the 1st dose of Hep B on 14Jan2009, 2nd dose on15Apr2009 and 3rd dose on 13Aug2009; the 1st dose of MMR on 23Apr2010; the first dose of VARIVAX on 23Apr2010; the first dose of ROTAVIRUS VACCINE on 14Jan2009, 2nd dose on 12May2009 and 3rd dose on 11Jun2009. On 09Feb2011, following administration of the vaccination, the patient was hospitalized after having been diagnosed with pneumonia and pneumothorax. The patient underwent lab tests and procedures which included blood immunoglobulin A: 113 mg/dl on 14Feb2011, blood immunoglobulin E: 24h mg/dl on 14Feb2011, blood immunoglobulin G: 946 mg/dl on 14Feb2011, blood immunoglobulin M: 123 mg/dl on 14Feb2011. Culture Blood (09Feb2011): Strep. Pneumo Serotype: 19A MRSA Screen culture (10Feb2011): No MRSA Detected. Culture Blood: (10Feb2011): no Growth. C difficile Toxin (13Feb2011): Negative for Clostridium Toxin. HIBE (15Feb2011): 7.1 ug/ml NBT:(15Feb2011): 65 L % Sweat volume 70 UL: (16Feb2011): sweat CL(MMOL/L) 47 f (Intermediate (30-59mmol/L) CRP: (10Feb11): 30.7 Hf CRP (12Feb2011): 21.5 Hf CRP (13Feb2011): 17.8 Hf CRP (14Feb2011): 29.0 Hf CRP (15Feb2011): 22.0 Hf CRP (18Feb2011): 15 Hf CRP (21Feb2011): 7.0 Hf CRP (24Feb2011): 4.4 Hf CRP (28Feb2011): 1.9 Hf Complete TOT (14Feb2011): 250 Hf Vancomycin (12Feb2011): 8 f (mcg/ml). The outcome of the event at the time of the report was recovered. Follow-up (22Dec2011): New information reported by contactable physician provided medical history, past product history, concomitant medications, clinical course, lab data, and event outcome.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Blood immunoglobulin M normal, C-reactive protein increased, Clostridium test, Drug level therapeutic, Immunology test
Clinical narrative: This is an spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 3-year-old child (gender unknown) received a dose of PREVNAR 13 (Lot E 87534) on an unspecified date. Relevant medical history included viral URI immediately prior to onset pneumonia. Concomitant vaccines included Influenza virus vaccine and Hep A. Past product history included dose one of PREVNAR on 14Jan2009, 2nd dose on 17Mar2009, 3rd dose on 12May2009 and 4th dose on 03Dec2009; the 1st dose of DTaP on 14Jan2009, 2nd dose on 15Apr2009, 3rd dose on 12May2009, 4th dose on 16Feb2010; the 1st dose of Hib on 14Jan2009, 2nd dose on 17Mar2009 and 3rd dose on 03Dec2009; 1st dose of IPV on 13Aug2009, 2nd dose on 16Feb2010, and 3rd dose on 26Jun2010; the 1st dose of Hep B on 14Jan2009, 2nd dose on15Apr2009 and 3rd dose on 13Aug2009; the 1st dose of MMR on 23Apr2010; the first dose of VARIVAX on 23Apr2010; the first dose of ROTAVIRUS VACCINE on 14Jan2009, 2nd dose on 12May2009 and 3rd dose on 11Jun2009. On 09Feb2011, following administration of the vaccination, the patient was hospitalized after having been diagnosed with pneumonia and pneumothorax. The patient underwent lab tests and procedures which included blood immunoglobulin A: 113 mg/dl on 14Feb2011, blood immunoglobulin E: 24h mg/dl on 14Feb2011, blood immunoglobulin G: 946 mg/dl on 14Feb2011, blood immunoglobulin M: 123 mg/dl on 14Feb2011. Culture Blood (09Feb2011): Strep. Pneumo Serotype: 19A MRSA Screen culture (10Feb2011): No MRSA Detected. Culture Blood: (10Feb2011): no Growth. C difficile Toxin (13Feb2011): Negative for Clostridium Toxin. HIBE (15Feb2011): 7.1 ug/ml NBT:(15Feb2011): 65 L % Sweat volume 70 UL: (16Feb2011): sweat CL(MMOL/L) 47 f (Intermediate (30-59mmol/L) CRP: (10Feb11): 30.7 Hf CRP (12Feb2011): 21.5 Hf CRP (13Feb2011): 17.8 Hf CRP (14Feb2011): 29.0 Hf CRP (15Feb2011): 22.0 Hf CRP (18Feb2011): 15 Hf CRP (21Feb2011): 7.0 Hf CRP (24Feb2011): 4.4 Hf CRP (28Feb2011): 1.9 Hf Complete TOT (14Feb2011): 250 Hf Vancomycin (12Feb2011): 8 f (mcg/ml). The outcome of the event at the time of the report was recovered. Follow-up (22Dec2011): New information reported by contactable physician provided medical history, past product history, concomitant medications, clinical course, lab data, and event outcome.