chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Fatigue, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: Tolerated past immunizations without difficulty. With Anthrax (1) vaccine, noted some site soreness starting p.m. of vaccination and continuing for 4-5 days. Had pre-treated with MOTRIN 800 mg and continued MOTRIN x 2 days post-vaccination. No significant redness, warmth or nodules at vaccination site. Describes pain as dull, aching pain surrounding vaccination site which seemed to resolve by 5th day post-vaccine. However, on 17 Sep, SM reports pain returned, but was more intense (up to 8/10 on pain scale of 0-10). Also on 17 Sep, noted swelling of R) upper arm and noted the pain more with reaching movements, adduction across chest, and with pressure applied around vaccine site (not extending to shoulder or across chest, but below vaccine site to about 1-2" above elbow). No other vaccines were received in that arm on 8 Sep. SM denies any recent or previous injuries, trauma or surgeries of R) UE. Noted some fatigue the first few days following vaccine receipt, which has improved. Noted generalized body aches and joint pains over first few days, which receive within 5-7 days. No Pruritus in area of vaccine site, no localized erythema, no red streaking, and no nodule at vaccine site - exam essentially normal except for pain to palpation and ROM limited due to pain.
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site swelling, No reaction on previous exposure to drug, Pain
Clinical narrative: Tolerated past immunizations without difficulty. With Anthrax (1) vaccine, noted some site soreness starting p.m. of vaccination and continuing for 4-5 days. Had pre-treated with MOTRIN 800 mg and continued MOTRIN x 2 days post-vaccination. No significant redness, warmth or nodules at vaccination site. Describes pain as dull, aching pain surrounding vaccination site which seemed to resolve by 5th day post-vaccine. However, on 17 Sep, SM reports pain returned, but was more intense (up to 8/10 on pain scale of 0-10). Also on 17 Sep, noted swelling of R) upper arm and noted the pain more with reaching movements, adduction across chest, and with pressure applied around vaccine site (not extending to shoulder or across chest, but below vaccine site to about 1-2" above elbow). No other vaccines were received in that arm on 8 Sep. SM denies any recent or previous injuries, trauma or surgeries of R) UE. Noted some fatigue the first few days following vaccine receipt, which has improved. Noted generalized body aches and joint pains over first few days, which receive within 5-7 days. No Pruritus in area of vaccine site, no localized erythema, no red streaking, and no nodule at vaccine site - exam essentially normal except for pain to palpation and ROM limited due to pain.
Age: 0.41
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Body temperature increased, Crying, Screaming
Clinical narrative: Temperature 100.6 (per parent). Cried and screamed from 9:00 AM to 3 P.M. 7/14/10.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Pt received the vaccination  on Tuesday 9/21/10 and on 9/22/10 noticed a rash surrounding the injection site that is warm to the touch. Pt was referred to her physician for follow up.
Age: 36.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Received call from pt at 4:10pm c/o "Hives and itchy all over". Denies SOB or respiratory distress. Pt states he bought and started BENADRYL.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia eye, Hypoaesthesia facial, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of feeling of paralysis in a 45-year-old female subject (also a nurse) who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 13 September 2010 the subject received a single dose of BOOSTRIX at 0.5 ml in the left arm. On 15 September 2010, 2 days after vaccination with BOOSTRIX, at about 13:15, the subject experienced feeling of paralysis described as paralyzing numbness and tingling of the face (both sides) and around the eyes to her mouth (facial numbness, facial tingling, numbness around eyes, tingling around eyes, numbness around mouth, tingling around mouth). It was also reported that the subject's speech was altered. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. Attribution of the events to BOOSTRIX was not indicated.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Paralysis, Speech disorder, VIIth nerve paralysis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of feeling of paralysis in a 45-year-old female subject (also a nurse) who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 13 September 2010 the subject received a single dose of BOOSTRIX at 0.5 ml in the left arm. On 15 September 2010, 2 days after vaccination with BOOSTRIX, at about 13:15, the subject experienced feeling of paralysis described as paralyzing numbness and tingling of the face (both sides) and around the eyes to her mouth (facial numbness, facial tingling, numbness around eyes, tingling around eyes, numbness around mouth, tingling around mouth). It was also reported that the subject's speech was altered. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. Attribution of the events to BOOSTRIX was not indicated.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia
Clinical narrative: Couple days pt was unable to move arm. Three weeks later not able to move arm still.
Age: 37.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Arthralgia, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, chills, muscle pain/joint, nausea.
Age: 36.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Tremor
Clinical narrative: Shakes. Fever 101 - 101.6. Redness at inj. site, swelling inj. site.
Age: 43.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia
Clinical narrative: Weak.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Headache.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Headache.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Headache.
Age: 34.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Chills achy, flu-like symptoms fever red/swollen inj. site.
Age: 34.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Chills achy, flu-like symptoms fever red/swollen inj. site.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash
Clinical narrative: One hour after shot was given I started itching all over noticed fine bumps on my face but not on my body. I've put cream on my face and body and I'm still itching the following day.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Ear pain, Headache, Hypoaesthesia facial, Hypoaesthesia oral
Clinical narrative: Flu shot Thurs 9/9/10 3PM. SAT 9/11 2PM Headache and pain to left ear & neck. Went to ER. Tues 9/14 (L) side of face numb. Wed 9/15 decreased sense of taste, lips numb, blurred vision in left eye. Went to PCP who diagnosed Bells Palsy believed to be R/C a virus. PCP gave RX for FAMVIR and prednisone. As of 9/23 s/sx resolving.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypogeusia, Neck pain, VIIth nerve paralysis, Vision blurred
Clinical narrative: Flu shot Thurs 9/9/10 3PM. SAT 9/11 2PM Headache and pain to left ear & neck. Went to ER. Tues 9/14 (L) side of face numb. Wed 9/15 decreased sense of taste, lips numb, blurred vision in left eye. Went to PCP who diagnosed Bells Palsy believed to be R/C a virus. PCP gave RX for FAMVIR and prednisone. As of 9/23 s/sx resolving.
Age: 92.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Herpes zoster, Rash, Scab
Clinical narrative: Red, scabbed rash at waist on back - painful - required MD visit. Pt. now on VALTREX Dx: Shingles.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: (L) arm pain, red & hot at injection site started the evening after having injection. Pt c/o fevers, h/a & body aches day after injection. Injection site measured 4 cm red & indurated 2 days after shot. Arm pain resolving.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: (L) arm pain, red & hot at injection site started the evening after having injection. Pt c/o fevers, h/a & body aches day after injection. Injection site measured 4 cm red & indurated 2 days after shot. Arm pain resolving.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Injection site erythema
Clinical narrative: Dime size red areas on (L) thigh.
Sex: U
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dyskinesia, Syncope
Clinical narrative: Mom states pt fainted and body with jerking movements the next morning.
Age: 1.85
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None Stated.
Age: 1.28
Sex: U
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Pt. developed chicken pox 11 days after VZV shot #1 was administered.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Developed varicella like rash on trunk onset one day ago.
Age: 2.9
Sex: F
Vaccine: PNC13
Symptoms: Febrile convulsion, Viral infection
Clinical narrative: Additional information was received in event details. Information regarding PREVNAR 13 was received from a nurse regarding a 33-month-old female patient who experienced a febrile seizure and a viral infection. The patient received the first dose on 07-Jun-2010. No medical history of seizures. The patient experienced a febrile seizure on 07-Jun-2010. The febrile seizure occurred the evening that the patient was vaccinated, and the patient was taken to the Emergency Room and was later admitted to the hospital. Follow-up information revealed that the patient was found to have a viral infection (unknown date) in Jun-2010. The physician no longer believes that the febrile seizure was due to vaccination, but that febrile seizure was due to the viral infection. Neither diagnostic tests nor treatments were reported. Febrile seizure resolved. The outcome of viral infection is unknown. No additional information was available at the time of this report.
Age: 4.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 4-year-old male patient who experienced developing a red hot golf ball sized swelling at the injection site. At 4 years of age, the patient received the first dose in May-2010. The patient also received a dose of MMR II (Merck) and a dose of VARIVAX (Merck) in May-2010. The patient experienced developing a red hot golf ball sized swelling at the injection site in May-2010. The outcome of the events is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Information was received from a healthcare professional regarding a patient who received no therapy and experienced more pain after receiving PREVNAR than reported with receipt of MMR vaccine. The patient experienced more pain after receiving PREVNAR than reported with receipt of MMR vaccine. Patient's receiving PREVNAR 13, report a pain threshold of 9 or 10 out of 10 compared to 5 out of 10 for MMR vaccine. No outcome was reported. The reporter was unable to specify the number of patient's who experienced this event. Additional reports will be generated when identifying information is provided. No additional information was available at the time of this report. See related case(s): US-WYE-H15453010 (adverse event, non-expedited).
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Information regarding PREVNAR 13 was received from a physician assistant regarding a patient (age and sex unknown) who experienced redness, inflammation and skin warm to the touch after vaccine administration. The patient received a dose on an unspecified date. The patient experienced redness, inflammation and skin warm to the touch after vaccine administration. The outcomes are unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling, Pyrexia, Vaccination complication
Clinical narrative: Information regarding PREVNAR 13 was received from a physician assistant regarding a patient who was younger than 5 years of age and experienced high fevers, unspecified side effects and enormous swelling at the injection site. The patient received the first dose in 2010. In 2010, the patient experienced high fevers, unspecified side effects and enormous swelling at the injection site. The outcome was unknown. The reporter suspects the vaccine caused the events. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 35-month-old male patient who experienced warm redness at injection site, tenderness at injection site and warm redness at injection site. At 23 months of age, the patient received a dose on 20-Apr-2010. The patient experienced warm redness at injection site, tenderness at injection site and warm redness at injection site on 21-Apr-2010. The outcome of all events is unknown. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Blood count normal, Blood culture negative, Blood electrolytes normal, Convulsion
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 24-month-old male patient who experienced seizure. The patient received a dose on 08-Jun-2010. Patient received PREVNAR therapy on 08-Jun-2010. On 09-Jun-2010, the patient experienced a seizure and was admitted to the hospital. Patient recovered on an unspecified date. No further information was provided.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced severe stinging. The patient received a dose on an unspecified date. The patient experienced severe stinging. Outcome was unknown. No additional information was available at the time of this report. The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided.
Age: 0.33
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Additional information provided test results. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 4-month-old female patient who received a dose of PREVNAR 13 that had been improperly stored. At 4 months of age, the patient received the first dose on 24-May-2010. The patient received a dose of PREVNAR 13 that had been improperly stored on 24-Mar-2010. Office refrigerator went up to 14 degrees Celsius for an unknown length of time. No adverse event was reported. Outcome: not recovered. No additional information was available at the time of this report. See related case(s): CN-WYE-H15411910 (adverse event, non-expedited).
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Malaise, Pyrexia
Clinical narrative: Follow-up information was received that indicated the reporter refused any further information. Information regarding PREVNAR 13 was received from a consumer regarding a 4-year-old female patient who experienced fever, felt sick and rash at injection site. The patient received a dose on 25-Jun-2010. The patient experienced fever, felt sick and rash at injection site on 25-Jun-2010. No treatment was reported. The patient recovered. No additional information was available at the time of this report.
Sex: F
Vaccine: PNC13
Symptoms: Incorrect storage of drug
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a female patient who experienced administered PREVNAR 13 which was stored out of temperature range. The patient received a dose on 03-Jun-2010. The patient experienced administered PREVNAR 13 which was stored out of temperature range on 03-Jun-2010. No adverse event was reported. No additional information was available at the time of this report.
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 12-month-old male patient who experienced diarrhea. At 12 months of age, the patient received the first dose on an unspecified date. The patient was administered PREVNAR 13 and experienced diarrhea within days and was hospitalized. The patient recovered. See related case: US-WYE-H16986310 (adverse event, non-expedited). No additional information was available at the time of this report.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Gait disturbance, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Follow-up information was received in patient demographics, test results and outcome of events. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old female patient who experienced rash, tactile fever, limping left leg, decreased appetite, redness at injection site and swelling at injection site. At 3 years of age, the patient received the first dose on 17-Jun-2010. The patient experienced rash, tactile fever, limping left leg and decreased appetite in Jun-2010 and redness at injection site and swelling at injection site on 19-Jun-2010. Injection site redness and swelling resolved in JUN-2010. The other events resolved on unknown dates. No additional information was available at the time of this report.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Follow-up information was received in patient demographics, test results and outcome of events. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old female patient who experienced rash, tactile fever, limping left leg, decreased appetite, redness at injection site and swelling at injection site. At 3 years of age, the patient received the first dose on 17-Jun-2010. The patient experienced rash, tactile fever, limping left leg and decreased appetite in Jun-2010 and redness at injection site and swelling at injection site on 19-Jun-2010. Injection site redness and swelling resolved in JUN-2010. The other events resolved on unknown dates. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced swelling. The patient received a dose on an unspecified date. The reporter states that "they have seen a couple of patients in the office and on the phone who experienced swelling after receiving the vaccine". It is unknown if relevant testing was done, if there was any treatment or any diagnosis for these patients. As of 25-Jun-2010, the outcome of the event was unknown at the time of report. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Pain, Rash
Clinical narrative: Information regarding PREVNAR 13 was received from a physician regarding a patient who experienced pain and rash. The patient received a dose in Jun-2010. The patient experienced pain and rash in Jun-2010. Outcome is unknown for both events. No additional information was available at the time of this report.
Age: 0.58
Sex: M
Vaccine: HEP, PNC13
Symptoms: Rash generalised
Clinical narrative: This case was considered medically important. Additional information provided patient demographics, dose details, suspect vaccine, events details, outcome and test results. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 7-month-old male patient who experienced possible allergic reaction and rash starting on thigh and spreading to the whole body. The patient received the first dose on 12-May-2010. Additional suspect medication included Hepatitis B Vaccine. The patient experienced possible allergic reaction and rash starting on thigh and spreading to the whole body on 12-May-2010. The patient recovered. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Information regarding PREVNAR 13 was received from a physician regarding a patient who experienced injection site pain and injection site rash. The patient received a dose in Jun-2010. The patient experienced injection site pain and injection site rash in Jun-2010. Outcomes are unknown. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC13
Symptoms: Malaise
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a male patient who didn't do well. the patient received a dose on an unspecified date. The patient didn't do well. The outcome of the event is unknown. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC13
Symptoms: Malaise
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a male patient who experienced that he didn't do well. The patient received a dose in 2010. The patient experienced that he didn't do well in 2010. The reporter explained that this patient is not a patient of this medical office and that she had no additional information other than what has been provided.
Age: 3.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old female patient who experienced leg hurting and fever. At 3 years of age, the patient received a dose on 25-Jun-2010. The patient also received a dose of HIB (manufacturer unknown) on 25-Jun-2010. The patient experienced leg hurting and fever on 25-Jun-2010. The outcome is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding an unknown number of patients who experienced very large, warm, bumps or knots at injection site. The patients received a dose on unknown dates in 2010. The patients experienced very large, warm, bumps or knots at injection site in 2010. The reporter commented that she sees this reaction more often when the child or infant is receiving a catch-up dose and the events are usually seen within 2 days after administration of the vaccine. Outcomes are unknown. No additional information was available at the time of this report.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal discomfort, Asthenia, Balance disorder, Decreased appetite, Fatigue
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding a 75-year-old male patient who experienced listlessness, off balance, fatigue/tired, upset stomach, lack of energy, body aches, no appetite and tenderness/soreness at injection site. At 75 year of age, the patient received a dose on 23-Jun-2010. The patient experienced listlessness and off balance in 2010, fatigue/tired, upset stomach, lack of energy, body aches and no appetite in Jun-2010 and tenderness/soreness at injection site on 24-Jun-2010. The patient was recovering from all the events except injection site tenderness which was reported as recovered. No additional information was available at the time of this report.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Listless, Pain
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding a 75-year-old male patient who experienced listlessness, off balance, fatigue/tired, upset stomach, lack of energy, body aches, no appetite and tenderness/soreness at injection site. At 75 year of age, the patient received a dose on 23-Jun-2010. The patient experienced listlessness and off balance in 2010, fatigue/tired, upset stomach, lack of energy, body aches and no appetite in Jun-2010 and tenderness/soreness at injection site on 24-Jun-2010. The patient was recovering from all the events except injection site tenderness which was reported as recovered. No additional information was available at the time of this report.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old female patient who experienced ring around injection site. At 3 years of age, the patient received a dose in Jun-2010. The patient experienced ring around injection site in Jun-2010. The patient recovered. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding an unknown number of patients who experienced an increase of minor side effects from PREVNAR 13 over PREVNAR. The patients received a dose on unspecified dates. The patients experienced an increase of minor side effects from PREVNAR 13 over PREVNAR. No additional information was available at the time of this report. The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided.
Sex: U
Vaccine: PNC13
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding an unknown number of patients who experienced administration of vaccine stored at 29 degrees C. The patients received a dose in 2010. The patients experienced administration of vaccine stored at 29 degrees C in 2010. No adverse events were reported. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information regarding PREVNAR 13 was received from a physician assistant regarding a patient who experienced cellulitis, erythema, tenderness on palpation, warmth and swelling. The patient received a dose on an unspecified date. On an unknown date, after the immunization the patient experienced erythema, swelling, warmth and tenderness on palpation at the injection site. The child was treated in an unspecified manner for cellulitis. They suspect a problem with the product. Outcome of the events was unknown. No additional information was available at the time of this report.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Irritability
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding a 12-month-old female patient who experienced fussiness. The patient received a dose on an unspecified date in 2010. The patient experienced fussiness in 2010. Outcome was unknown. No additional information was available at the time of this report. See related case(s): US-WYE-H16741310 (adverse event, non-expedited).
Sex: U
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information regarding PREVNAR 13 was received from a physician assistant regarding a patient who experienced cellulitis, tenderness on palpation, warmth, erythema and swelling. The patient received a dose on an unspecified date. On an unknown date, after the immunization, the patient experienced erythema, swelling, warmth, and tenderness on palpation at the injection site. The affected area was 14 by 11 centimeters. The child was treated in an unspecified manner for cellulitis. They suspect a problem with the product. Outcome of the events was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information regarding PREVNAR 13 was received from a physician assistant regarding a patient who experienced cellulitis, erythema, tenderness on palpation, warmth and swelling. The patient received a dose on an unspecified date. On an unknown date, after the immunization, the patient experienced erythema, swelling, warmth and tenderness on palpation at the injection site. The child was treated in an unspecified manner for cellulitis. They suspect a problem with the product. Outcome of the events was unknown. No additional information was available at the time of this report.
Age: 0.75
Sex: F
Vaccine: PNC, PNC13
Symptoms: Accidental overdose, Crying, Wrong drug administered
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding a 9-month-old female patient who experienced crying after receiving the injection, accidental overdose and receiving vaccine by mistake - dose was supposed to be given to another child. The patient received the first dose on 03-Aug-2010. The patient experienced crying after receiving the injection, accidental overdose and receiving vaccine by mistake - dose was supposed to be given to another child on 03-Aug-2010. The patient had previously received 3 doses of PREVNAR. Outcome was unknown. No additional information was available at the time of this report.
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding an 18-month-old female patient who experienced cellulitis, redness, tenderness on palpitation at the injection site, warmth and swelling. The patient received a dose on an unspecified date. Additional suspect medication included Hepatitis A Vaccine. The patient experienced cellulitis, redness and tenderness on palpitation at the injection site in Jul-2010. The patient also experienced warmth and swelling. Treatment included ceftriaxone and cephalexin. At the time of the report, the outcome of the events was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Abasia, Injection site pain, Injection site warmth
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old patient who experienced leg was hot to touch and was very sore and could not walk. The patient received a dose in Jul-2010. The patient experienced leg was hot to touch and very sore and could not walk in Jul-2010. The outcome of the events was unknown. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Abasia, Injection site pain, Injection site warmth
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old male patient who experienced complained that he could not walk, leg was sore and leg was hot to the touch. At 3 years of age, the patient received a dose in Jul-2010. A couple days after receiving PREVNAR therapy, the patient complained that he could not walk, his leg was sore and leg was hot to the touch in Jul-2010. Patient was advised to take TYLENOL for treatment. Outcome and further details were unknown.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site haematoma, Injection site mass, Injection site warmth, Wrong technique in drug usage process
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 6-month-old female patient who experienced extreme redness and bruising at the injection site with a small not raised bump underneath the skin. It was noted that the healthcare professional did not shake the syringe before administering it. The patient received a dose on 23-Jul-2010. The patient experienced extreme redness and bruising at the injection site with a small not raised bump underneath the skin at the injection site in Jul-2010. It was reported that the healthcare professional did not shake the syringe before administering it on 23-Jul-2010. No additional information was available at the time of this report.
Age: 1.3
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Pyrexia, Vaccination site cellulitis, Vomiting
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 15-month-old male patient who experienced vaccination site cellulitis, vomiting and fever. At 15 months of age, the patient received the second dose on an unspecified date. Additional suspect medication included Varicella Virus Vaccine, Live administered in the same leg as PREVNAR 13. The patient experienced vaccination site cellulitis, vomiting and fever. The patient recovered. See related case(s): US-WYE-H16922210 (adverse event, expedited). No additional information was available at the time of this report.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Urticaria
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding a 4-year-old female patient who experienced injection site hard red welt. At 4 years of age, the patient received a dose on 16-Aug-2010. It was reported that the child had completed her PREVNAR 7 history by the age of 2 years and fell within the window of needing a booster shot. On 16-Aug-2010 after receiving PREVNAR 13, some redness was noted when the patient's Band-Aid was removed. The next day a hard, red welt bigger than 1 inch but smaller than 2 inches was noticed at the injection site. The event was called into the pediatrician's office: they reported that the welt was normal and a cold pack could be applied to the area. The outcome of the event was not specified.
Age: 1.91
Sex: F
Vaccine: PNC13
Symptoms: Crying, Gait disturbance, Injection site pain
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding a 23-month-old female patient who experienced severe pain and tenderness at injection site, would not let anyone touch her, began limping and began crying. The patient received a dose on 19-Aug-2010. The patient experienced tender to the touch and severe pain at injection site, would not let anyone touch her, began limping and began crying on 19-Aug-2010. Outcome for all events was unknown. No additional information was available at the time of this report.
Age: 4.0
Sex: U
Vaccine: PNC13
Symptoms: Oedema peripheral
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 4-year-old patient who experienced swelling of arm. At 4 years of age, the patient received a dose on 23-Aug-2010. The patient experienced swelling of arm on 23-Aug-2010. The outcome is unknown. No additional information was available at the time of this report.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Eczema, Vaccine positive rechallenge
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 6-month-old female patient who experienced exacerbation of eczema. At 6 months of age, the patient received the first dose on 25-May-2010. The patient also received the third dose of ROTATEQ (Merck & Co Inc) and the third dose of PENTACEL (Aventis-Pasteur) on 25-May-2010. On 10-Jun-2010 the patient experienced exacerbation of eczema. The patient was seen by the dermatologist. The patient recovered. See related case(s): US-WYE-H17059810 (adverse event, non-expedited) for the same event following PREVNAR administration at 4 months of age. No additional information was available at the time of this report.
Age: 1.02
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site rash, Urticaria
Clinical narrative: This case was considered medically important for event of hives. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 12-month-old male patient who experienced slight rash around the injection site and hives all over. At 12 months of age, the patient received a dose on 16-Jun-2010. The patient also received a dose of HIB (GlaxoSmithKline) on 16-Jun-2010. The patient experienced slight rash around the injection site on 16-Jun-2010 and hives all over on 17-Jun-2010. It was advised to give the child diphenhydramine (dose unknown) and to bring the patient back to the office if no improvement. The outcome was unknown. No additional information was available at the time of this report.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Condition aggravated, Convulsion, Pyrexia
Clinical narrative: This case was considered medically important for the event of seizure and condition aggravated. Information regarding PREVNAR 13 was received from a nurse practitioner regarding her 4-year-old daughter who experienced seizure and condition aggravated, and fever after the vaccine and seizure. At 4 years of age, the patient received the first dose on 18-Jun-2010. The patient experienced seizure and condition aggravated on 18-Jun-2010. The patient had been pre-medicated at 13:00 with an unspecified medication, prior to vaccination at 15:30 as a catch-up dose. In Jun-2010, after the vaccine and the seizure, the patient had a fever. Treatments are unknown. The nurse practitioner states that currently her daughter is fine, however it is unknown if the patient is still recovering from the events, or has fully recovered. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Blood test, Convulsion
Clinical narrative: This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 29-month-old male patient who experienced seizure. At 29 months of age, the patient received a dose on 29-Jun-2010 along with a second dose of VAQTA (Merck) and a dose of TRIPACEL (Aventis-Pasteur) on 29-Jun-2010. On 29-Jun-2010, at 3:00 PM, the patient experienced a seizure. The patient was taken to the emergency room, where (unspecified) blood work was performed (no results available). No treatment was reported. The patient was discharged to home. The outcome was not reported. No additional information was available at the time of this report.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Follow-up information was received regarding patient details, product details, event details, concomitant therapy, treatment and medical history. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 6-month-old female patient who experienced urticarial rash all over body with no breathing difficulty. The patient received the first dose on 12-May-2010. The patient also received the third dose of ROTATEQ (Merck) and the third dose of PENTACEL (Aventis-Pasteur) on 12-May-2010. The patient experienced urticarial rash all over body with no breathing difficulty on 12-May-2010. BENADRYL cream was applied. The patient has fully recovered. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Information regarding PREVNAR 13 was received from a physician regarding a patient who experienced rash. The patient received a dose in 2010. The patient experienced rash in 2010. The outcome is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding an unknown number of patients who experienced vomiting within one to two days following administration of vaccine. The patient received a dose in 2010. The patients experienced vomiting within one to two days following administration of vaccine on unknown dates in 2010. The outcome is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Information regarding PREVENAR 13 was received from a physician regarding a patient who experienced rash. The patient received a dose in 2010. The patient experienced rash in 2010. The outcome was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding a patient who experienced swelling at the injection site. The patient received a dose on 04-May-2010. The patient experienced swelling at the injection site in Jun-2010. The outcome is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Crying, Pyrexia
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced inconsolable and high fever. The patient received a dose on an unspecified date. The patient experienced inconsolable and high fever on 29-Jun-2010. The outcome was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Crying, Pyrexia
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced being inconsolable and having a high fever. The patient received a dose on 29-Jun-2010. The patient experienced inconsolable and high fever on 29-Jun-2010. The outcome is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Emotional distress, Pyrexia
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced inconsolable and high fever. The patient received a dose on 29-Jun-2010. Patient received PREVNAR therapy on 29-Jun-2010. The patient was then inconsolable and experienced a high fever in Jun-2010. Outcome was not provided. No further information was provided.
Age: 0.7
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Rash generalised, Rash papular
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding an 8-month-old female patient who experienced generalized papular erythema described as "scant" on the posterior trunk, on her head and 4 extremities, hive-like in appearance and generalized papular erythema. At 8 months of age, the patient received a dose in Jun-2010, along with a dose of ROTARIX (GlaxoSmithKline) and a dose of PENTACEL (Aventis-Pasteur) in Jun-2010. In Jun-2010, the patient experienced generalized papular erythema described as "scant" on the posterior trunk, on her head and 4 extremities, hive-like in appearance. Treatment was not reported. The outcome was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding a patient (unknown age and sex) who experienced high fever. The patient received a dose on an unknown date in 2010. The patient experienced high fever on an unknown date in 2010. The patient did not get any vaccines other than PREVNAR 13. The patient had to return to the doctor's office due to the high fever. Treatments are not reported. The outcome of fever is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13, UNK
Symptoms: Pyrexia
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding a patient who experienced high fever. The patient received a dose in 2010. The patient experienced high fever on an unknown date in 2010. Outcome is unknown. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC13, DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a pediatrician regarding a 30-month-old male patient who experienced severe local reaction - pain, swelling, redness. The patient received the first dose in Jun-2010. The patient experienced severe local reaction - pain, swelling, redness on 11-Jun-2010. All events resolved on an unknown date. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC13, DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Information regarding PREVNAR 13 was received from a pediatrician regarding a 30-month-old male patient who experienced severe local reaction - pain, swelling, redness. The patient received the first dose in Jun-2010. The patient experienced severe local reaction - pain, swelling, redness on 11-Jun-2010. All events resolved on an unknown date. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13, DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced after dose was given child cried for three hours. The patient received a dose on an unspecified date. The patient experienced after dose was given child cried for three hours. The doctor disclosed this was the second child. Patient recovered on an unspecified date. See related case(s): US-WYE-H16202210 (adverse event, non-expedited). No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13, DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced after dose was given child cried for three hours. The patient received a dose on an unspecified date. The patient experienced after dose was given child cried for three hours. The doctor disclosed this was the second child. Patient recovered on an unspecified date. See related case(s): US-WYE-H16202210 (adverse event, non-expedited). No additional information was available at the time of this report.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 4-year-old female patient who experienced redness, tenderness and soreness at injection site and redness, tenderness and soreness at injection site. The patient received the first dose in Jun-2010. On an unspecified date in Jun-2010, approximately 48 hours post-vaccination, the patient experienced redness, tenderness and soreness at injection site reported as "about the size of a grapefruit or softball". The patient returned to the physician's office where no infection was noted. Treatment was not reported. As of 16-Jun-2010, the patient had recovered. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced injection site pain and rash. The patient received a dose in 2010. The patient experienced injection site pain and rash in 2010. Treatment and outcomes for the events were unknown. No further information was provided.
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced cried for three hours. The patient received a dose on an unspecified date. Additional suspect medication included PENTACEL and ROTATEQ. On an unspecified date after receiving vaccine, the patient experienced cried for three hours. The patient recovered. No additional information was available at the time of this report.