chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A patient of unknown age, gender and ethnicity received TRUMENBA at 0.5 ml single dose on unspecified date. Concomitant medications and medical history were not reported. About 5 hours after the injection was given, the patient had site reactions, warm, red, and a little hurt, painful and there was some itching too, so the patient called back to the office and it was suggested to BENADRYL because of the itching and redness. The patient was told to call back if symptoms persisted, but patient did not call back so the physician assumed everything was fine. The physician visited the patient the following week for something unrelated and everything was fine. Causality was not available. Follow-up (10JUL2015): Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chromaturia, Myalgia, Protein urine present, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 19-year-old male patient of unknown ethnicity received in May2015 TRUMENBA at 0.5 ml single dose in the arm and MENVEO in the other arm. Relevant medical history and concomitant medications were not reported. In May2015, after vaccination (unknown if on the same date or day after), the patient experienced very strong muscle pain in the same arm in which he received TRUMENBA, very high fever and his urine color was found orange instead of yellow. An urine test performed in May2015 showed the presence of protein. It was the first time the patient showed protein in his urine. The physician wanted to evaluate whether the patient should received the second dose of TRUMENBA or not. The reporting physician considered the events as due to TRUMENBA. Outcome was not recovered. Follow-up (09JUL2015): Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Feeling abnormal, Headache, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 18-year-old female patient received second dose of TRUMENBA, via an unspecified route of administration, on 12MAY2015, at single dose. Relevant medical history was not reported. Concomitant medications included ADDRALL at 5 mg daily and PROZAC at 20 mg daily. The patient experienced chills, she was shaking a lot, she got shoot headaches and she felt very bad as she got a sudden reaction on 12MAY2015. Outcome of the reported events was not recovered at the time of this report.  Follow-up (01JUL2015): Follow-up attempts completed. No further information expected.
Age: 14.0
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased, Vaccination site pain, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable physician through via a Pfizer Vaccine Sales Representative. A 14 years old female patient received a single dose of TRUMEMBA (lot J28923, expiry date Jun2016) on 11Mar2015 and on 15May2015, at single dose. Medical history and concomitant medications were not provided. The patient experienced on unspecified dates in 2015, after both vaccinations, limited arm movements, severe pain, swelling after the administration of the vaccine. The events occurred at vaccine site. Events outcome was not provided. The events did not require an emergency room or physician visit. The patient was not admitted to hospital. No specified tests and/or treatment were required. The physician considered there was a reasonable possibility that the event was related to suspect product. Follow-up (09Jul2015): Follow-up attempts completed. No further information expected. Follow-up (15Jul2015): New information from the same contactable physician includes: patient date in Birth, age and gender, vaccinations dates, lot number, expiry date, route of administration, anatomical location, reporter causality assessment.
Sex: U
Vaccine: MENB
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: This is a spontaneous report from a non Clinical Study Program IBCC (Inbound Call Center for HCP's) from a pediatrician though a sales representative. A patient of unspecified age and gender received TRUMENBA via an unspecified route of administration on an unspecified date, single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced headache, joint and muscle pain throughout the body, pain at the injection site and fatigue. The events were assessed as non-serious. The outcome was unknown. Follow-up (15JUN2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A male patient of an unspecified age and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date. The outcome of the event was unknown. Follow-up (19JUN2015): Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Vaccination site pain
Clinical narrative: The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on 15JUL2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician. A 18 year old female patient received TRUMENBA (lot J28923, expiry date JUN2016) first single dose on 11MAR2015 and second single dose on 19MAY2015, both intramuscular in left arm. Medical history and concomitant medications were not provided. On unspecified dates in 2015, the patient experienced pain after administration of vaccine at the vaccine site after both firsts and second dose. The event did not require an emergency room or physician visit. Event outcome was unknown. The physician considered there was a reasonable possibility that the event was related to suspect product.
Sex: U
Vaccine: MENB
Symptoms: Bronchospasm
Clinical narrative: This is a spontaneous report from a contactable physician. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration at single dose on unknown date. The patient medical history and concomitant medications were not reported. The patient experienced bronchospasm on an unspecified date with outcome of unknown. Follow-up (26JUN2015): Follow-up attempts completed. No further information expected.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Full blood count normal
Clinical narrative: This is a spontaneous report from a contactable physician. A 22-year-old female patient received TRUMENBA, (lot number J28923, Expiry Date JUN2016), intramuscular on 27JUN2015 at 11:05 AM at 0.5 ml, single in the left deltoid. No other vaccines were administered on the same date or within four weeks. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medication included EFFEXOR for anxiety from FEB2015 to 23JUL2015 at 37.5 mg once a day orally. The patient experienced extreme fatigue on an unknown date in 2015. Outcome as recovered after 3 weeks on unspecified date in 2015. The patient underwent lab tests and procedures which included full blood count: normal in JUL2015. No treatment was provided. The physician considered that TRUMENBA had not a casual effect to the adverse event. Follow-up (04AUG2015): New information received from the same contactable physician includes: route, vaccination time, anatomical location of vaccination, casual relationship, outcome and information on treatment and concomitant medication. Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: MENB
Symptoms: Injection site rash
Clinical narrative: This is a spontaneous report from a contactable other HCP, a contactable medical assistant, calling from Doctor's office and from a contactable Physician. A 26-year old female patient received TRUMENBA (lot # J29203, Exp. Date: JUN2016 via intramuscular route of administration 0.5 ml single dose in MAR2015 at 9:30 AM in left deltoid. The patient did not have any other medical condition. Concomitant medication included TOPIRAMATE 100 mg, VITAMIN B, VITAMIN D, PROBIOTICS. On an unspecified date the patient experienced rash at the injection site over the half of the upper arm: there was kind of an imprint of the rash but could feel redness of the rash but had recovered. The outcome of the events was recovered. The event did not require an emergency room or physician visit. The physician assessed there a reasonable possibility that the event is related to suspect product. Follow up (16JUL2015): New information from a contactable Physician included: vaccine details, reporter's assessment. Follow up attempts completed. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced significant swelling. The outcome of the event was unknown. The reporting physician assessed the event as related to TRUMENBA and he thought that it occurred pretty regularly. Follow-up (25JUN2015): Follow-up attempts completed. No further information expected.
Age: 13.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer reporting on behalf of her son. A 13-year-old male patient received the first dose of TRUMENBA via an unspecified route of administration in the right on 15MAY2015 at around 4:45 PM at 0.5 ml single. No medical history, concomitant medications and relevant tests were reported. The patient experienced pain at injection site on 15MAY2015 at around 7 PM. The patient recovered on an unspecified date in MAY2015. According to the patient mother he would continue with the series of immunization. Follow-up (25JUN2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report from a contactable physician via sales representative. A male patient of an unspecified age and ethnicity received a single dose of TRUMENBA, via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. On an unknown date the patient developed a site reaction to the vaccine. The outcome of the event was unknown. Follow-up (19JUN2015): Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This spontaneous report from a contactable lawyer who reported for herself. This 26-year-old female patient received the first single dose of TRUMENBA intramuscular in the left arm on 28APR2015. The patient medical history was not reported, there were no concomitant medications. The patient experienced sore arm at the injection site on 28APR2015. The patient mentioned that she did not consult her physician and she did  not undergo any laboratory work due to the event. She further mentioned that the event was still ongoing. Follow-up (04JUNE2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This is a spontaneous report from sales representative on behalf of an Other Healthcare professional (the receptionist who was calling on behalf of physician) for a patient. This is the first report of three reports.  A female patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration at single dose on unknown date. The patient medical history and concomitant medications were not reported. The patient developed ring of welt at the injection site on an unspecified date with outcome of unknown.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable reporter who reported for 4 patients via a sales representative. This is 4th of the 4th report. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration at single dose on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced red swollen arm on an unspecified ate with outcome of unknown.
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a non clinical study program, received from a non-contactable consumer (patient's mother). A 17-year-old female patient received a single dose of TRUMENBA, via an unspecified route of administration in JUL2015 to an unspecified date. Medical history and concomitant medications were not reported. The patient experienced headache, chills, facing fever and a lot of pain in her legs along with her thighs, all on an unspecified date. The patient was not recovered from pain in her legs along with her thighs. The outcome of the other events was unknown. The reporter stated the patient got this vaccine on an unspecified Saturday morning and, at the time of reporting, it has been 48 hours and there was lot of pain in her legs along with her thighs and she wanted to know low long these side effects would have lasted.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Pain
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a sales representative. This nurse reported about two different children. This is the second of two reports. A female child of an unspecified age and ethnicity received on 02JUL2015 at 11:29, TRUMENBA; (Lot J29203; Ex 30JUN2016) 0.5 ml at single dose, IM (intramuscularly), on the right UOQ in upper leg. Relevant medical history and concomitant medications were unknown. On an 02JUL2015, the patient experienced extreme pain. Clinical outcome of the event was recovered on 06JUL2015. Follow-up (11AUG2015): New information received from the same contactable nurse includes: product data, reaction data and outcome.
Sex: U
Vaccine: MENB
Symptoms: Dysstasia, Pain
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a sales representative. This nurse reported about two different children. This is the first of two reports. A child of an unspecified age, ethnicity and gender received, on an unspecified dater, TRUMENBA at single dose, via an unspecified route of administration, in upper leg. Relevant medical history and concomitant medications were unknown. ON an unspecified date, the patient experienced extreme pain and was unable to stand because of the pain. Clinical outcome of the events was unknown at the time of this report.
Sex: M
Vaccine: MENB
Symptoms: Erythema, Pain
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a sales representative. The physician's son of an unspecified age, and ethnicity received, on an unspecified date, TRUMENBA at single dose, via an unspecified route of administration. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced redness and pain. BENADFRYL was given as a therapeutic measure and event lasted for 3-4 days. The patient recovered from the events on an unspecified date.
Sex: U
Vaccine: MENB
Symptoms: Chills
Clinical narrative: This is a spontaneous report from a contactable reporter (contactable consumer or other non HCP, Manager and immunization coordinator for the department of health) who reported for 4 patients via a sales representative. This is 2nd of the 4th report. A patient of unspecified age ethnicity and gender received TRUMENBA via an unspecified route of administration on an unspecified date. The patient experienced body chills on an unspecified date with outcome of unknown.
Sex: U
Vaccine: PNC
Symptoms: Antibody test negative
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient, age unknown, received the 5th dose of PREVNAR on an unspecified date. Relevant medical history included IGA deficiency. Past product history included four doses of PREVNAR on unspecified dates. Concomitant medications were not provided. It was reported that the patient did not develop any antibodies. Therapeutic measures taken as a result of the event included treatment with a dose of PNEUMOVAX23. Sometime, thereafter, the patient developed antibodies. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: PNC
Symptoms: Cough, Drug ineffective, Influenza A virus test negative, Pneumonia, Respiratory distress
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding an adolescent female patient who experienced bilateral pneumonia. The patient received the fourth dose on an unspecified date. On an unknown date, the patient was initially diagnosed with swine flu and received therapy with TAMIFLU. She improved, but after 2 3 days she experienced coughing episodes. The patient was seen; testing for H1N1 was negative. The patient was then diagnosed with pneumonia and treated with AUGMENTIN. Two days later, the patient was in respiratory distress and seen in the ER. The patient was subsequently diagnosed with bilateral pneumonia (drug ineffective); ZITHROMAX was added to her treatment. The patient has improved.
Sex: U
Vaccine: HPVX, MENB, MNQ
Symptoms: Injection site pain, Myalgia
Clinical narrative: This is a spontaneous report from Pfizer sale representative who was reporting on behalf of non contactable physician for his patient. This is the third report of three reports. A patient of unspecified age ethnicity and gender received TRUMENBA, at single dose, MENACTRA and HUMAN PAPILLOMAVIRUS VACCINE, all via an unspecified route of administration on an unknown date. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain at the injection site and muscle pain that was radiated down to the hand. The outcome of the events was unknown.
Age: 1.02
Sex: M
Vaccine: PNC
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Follow up information was received that provided vaccine information, test results and outcome and medically confirmed this report. This case was considered medically important. Information regarding PREVNAR was received from a consumer and physician regarding a 12 month old male patient who received a dose on 25 Mar 20101 and experienced swelling of three inches in diameter in the thigh area at the site of injection that was painful to touch. Medical history: None. Indication for PREVNAR was immunization. Product was administered on 25 Mar 2010. Dose regimen was 1 dose 1 time per day. The vaccine had been stored as per manufacturer instructions. Concomitant therapy: None. On 25 Mar 2010, the patient developed swelling of three inches in diameter in the thigh area at the site of injection that was painful to touch. Treatment included TYLENOL. On an unspecified date, the patient recovered. Test results: Physical examination (results: The patient's language/speech, emotional/social, fine/gross motor skills and cognitive thinking developmental milestones were with normal range. The patient's physical growth has been normal) was done on an unspecified date. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Influenza, Malaise, Pneumonia
Clinical narrative: Information regarding PREVNAR was received from a  healthcare professional regarding an 8 year old male patient who experienced drug ineffective and pneumonia. At 15 months of age, the patient received the fourth dose on an unspecified date. The patient's concurrent illness includes asthma with a past history of H1N1 influenza. The patient received PREVNAR at the age of 2, 4, 6, and 15 months of age. Indication for PREVNAR was immunization. Product was administered on unspecified dates at the ages of 2, 4, 6, and 15 months. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. In 2009 the patient developed swine flu and was treated and "got better" but while still sick the patient experienced symptoms of pneumonia and was treated with antibiotics and recovered. No additional information was available at the time of this report.
Sex: U
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache
Clinical narrative: This is a spontaneous report from Pfizer sales representative on behalf of an other healthcare professional (the receptionist who was calling on behalf of physician) for a patient. The is the second of three reports. A patient of an unspecified age, gender and ethnicity received TRUMENBA single dose, on an unknown date. Relevant medical history and concomitant medications were unknown. The patient experienced headache, fatigue, and chills on an unspecified date. Clinical outcome of the events was unknown.
Age: 0.68
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Drug ineffective, Ear infection, Incorrect product storage
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding an 8 months old male patient who experienced ear infection, drug ineffective and vaccine stored below the recommended temperature range. At 8 months of age, the patient received a dose on 09 Apr 2010. The patient also received a dose of PEDIARIX (GlaxoSmithKline) and a dose of HIB (manufacturer unknown) on 09 Apr 2010. Relevant  medical history was not provided. Indication for PREVNAR was immunization. Product was administered on 09 Apr 2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. Patient received PREVNAR therapy on 09 Apr 2010. On an unspecified date (approximately 2.5 months after receiving vaccine in 2010), the patient experienced an ear infection and it was noted that the vaccine had been stored below the recommended temperature range. Patient had reportedly recovered. No further information was provided.
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a male patient who received 2 doses of PREVNAR at 4 months 20 days, then again 4 days later. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. The patient received 2 doses of PREVNAR at 4 months 20 days, then again 4 days later. At time of report, no adverse event had occurred.
Sex: F
Vaccine: PNC
Symptoms: Drug ineffective, Malaise, Pneumococcal bacteraemia, Streptococcus test positive, White blood cell count
Clinical narrative: This case was considered medically important. Additional information provided updated event details and laboratory results. Information regarding PREVNAR vaccine was received from a healthcare professional regarding a female child (between 2 and 3 years of age), who experienced pneumococcal bacteremia/drug ineffective. The patient received the fourth dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified date in 2010, the patient went to the physician's office appearing ill and very sick. The patient's white blood cell count was 15.4 and her blood culture was pneumococcal positive. The patient was not hospitalized. Treatment included 2 injection of Rocephin. As of 16 Jul 2010, the patient recovered. A repeat blood culture (date unspecified) showed negative results. In 2010 test results were: white blood cell count (results: 15.4); physical examination (results: physical growth and development normal); blood culture (results: repeat negative); and blood culture (results: positive for pneumococcal). No additional information was available at the time of this report.
Age: 1.08
Sex: M
Vaccine: PNC
Symptoms: Asthma, Asthma exercise induced, Condition aggravated, Incorrect product storage
Clinical narrative: Additional information provided patient demographics medical history and updated laboratory results. Information regarding PREVNAR was received from a healthcare professional regarding a 13-month-old male patient who experienced received PREVNAR that had been improperly stored (refrigerator temperature went from 41 to 69.8 degrees Fahrenheit), asthma exacerbation, asthma exacerbation and fever. The patient received a dose on 02-Apr-2010. The patient received PREVNAR that had been improperly stored (refrigerator temperature went from 41 to 69.8 degrees Fahrenheit) and experienced asthma exacerbation and fever on 02-Apr-2010. The patient recovered. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Food allergy
Clinical narrative: This is a spontaneous report from a non contactable nurse. A child (age and sex unknown) was administered a dose of PREVNAR on an unknown date. The route and site of administration were unknown. Relevant medical history was not provided. Concomitant medications were not provided. On an unknown date after vaccination, the patient developed an egg allergy. Diagnostic tests and treatments were not reported. The event was non-serious. The outcome of egg allergy was unknown.
Sex: U
Vaccine: MENB
Symptoms: Chills, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer via a sales representative. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced chills and headache on an unspecified date (the day after the vaccination) with outcome of unknown.
Sex: U
Vaccine: PNC
Symptoms: Nonspecific reaction
Clinical narrative: Information regarding PREVNAR was received from a company representative regarding a caller who had an unspecified concern regarding PREVNAR13. The patient received a dose on an unspecified date.  Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced unspecified concern regarding PREVNAR13 (non specified reaction). The outcome is unknown. No additional information was available at the time of this report.
Age: 1.25
Sex: M
Vaccine: PNC
Symptoms: Rash generalised, Urticaria
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 15 month old male patient who experienced hives and generalized rash. The patient received a dose on 27 Jun 2008. No known food or drug allergies. Indication for PREVNAR. Product was administered on 27 Jun 2008. Dose regimen was 1 dose 1 time per day. Additional suspect medication included INFANRIX IPV and HIB. Concomitant medications were not reported. The patient experienced hives and generalized rash on 03 Jul 2008. The patient recovered. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Local reaction
Clinical narrative: New information was received in source details only. Information regarding PREVNAR was received from a physician regarding an unknown number of patients who experienced a higher number of local reactions noted with dose 4 PREVNAR 7 than with first 3 doses. The patient received the fourth dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced higher number of local reactions noted with dose 4 of PREVNAR than with first 3 doses (local reaction). The outcome is unknown. No additional information was available at the time of this report.
Age: 1.07
Sex: M
Vaccine: PNC
Symptoms: Drug administration error, Pyrexia, Speech disorder developmental, Urticaria
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 12-month-old male patient who experienced fever of 100.5 degrees F. and hives on trunk and arms. At 12 months of age, the patient received the fourth dose on 02-Mar-2010. Medical history: Patient born at 38 weeks gestation; induced due to low fluid; mother 29 years of age. Product details: Indication for PREVNAR was immunization. Product was administered on 02-Mar-2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced fever of 100.5 degrees F. and hives on trunk and arms in Mar-2010. The reporter stated that the lot of PREVNAR administered was recalled. The outcome of the events is resolved. No additional information was available at the time of this report. Physical examination (results: head circumference 47 cm; language/speech within normal range; emotional/social within normal range; fine/gross motor skills within normal range; cognitive thinking within normal range; has not failed to meet developmental milestones since starting medication; physical growth normal but in low percentiles-weight 24%, length 20%) was done in Mar-2010. No additional information was available at the time of this report. Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of the migration, the follow-up CIOMS I, Medwatch or VAERS may indicate in the appropriate field that it is an initial report. Follow-up (08Mar2011): This is a spontaneous report from a contactable physician. The patient recovered from the events, however, the developmental milestones of language/speech is not within normal range; there is an ongoing "expressive speech delay". Emotional/social; fine/gross motor skills; and cognitive thinking were all within normal range. The child's physical growth has been normal.
Age: 0.52
Sex: F
Vaccine: PNC
Symptoms: Pyrexia, Rash generalised, Vaccination complication
Clinical narrative: Additional information provided updated outcome of events and event details, patient demographics and laboratory data. Information regarding PREVNAR was received from a healthcare professional regarding a 6 month old female patient who experienced rash all over body and fever. At 6 months of age, the patient received the third dose on 02 Feb 2010. Reported as "healthy". The patient noted no reaction occurred with the previous 2 doses of PREVNAR butt noted a sibling experienced rash following administration of MMR vaccine. Indication for PREVNAR was immunization. Product was administered on 02 Feb 2010. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. The patient experienced rash all over body on 02 Feb 2010 and fever on 03 Feb 2010. Treatment included BENADRYL. The patient was referred to an allergist who attributed the events to PREVNAR. The patient recovered from the events. Physical examination (results: birth weight 4395 kg, head circumference at birth 36.5 cm, length at birth 51 cm, normal birth) was done on 27 Jul 2009. Physical examination (results: weight at event 18lbs, head circumference 16.5 inches at event, length at event 70 cm, all developmental milestones normal) was done on 08 Apr 2010. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Rash
Clinical narrative: Information regarding PREVNAR 7 was received fro ma healthcare professional regarding a patient who experienced rash. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On an unspecified date, the patient experienced rash. The outcome was unknown. See related case (s): US WYE H15128310 (adverse event, non expedited) and US WYE H15204510 (adverse event, non expedited). No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Anger, Crying
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding an unspecified number of patients. The reporter stated that children cry the loudest and are most upset after the vaccine. It was also reported that this vaccine seems to be the most painful immunization for patients. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. The reporter stated that children cry the loudest (crying) and are most upset after the vaccine. It was also reported that this vaccine seems to be the most painful immunization for patients. Outcome was unknown. No additional information was available at the time of this report.
Sex: F
Vaccine: PNC
Symptoms: Erythema multiforme
Clinical narrative: Additional information provided patient demographics, change in adverse event, suspect vaccine, event details and test results. Information regarding PREVNAR was received from a healthcare professional regarding a female patient who experienced erythema mulitforme. The patient received the fourth dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Additional suspect medication included PEDVAXHIB. Concomitant medications were not reported. The patient experienced erythema multiforme three days after being administered the vaccine. The patient was taken to the Emergency Room. The patient recovered. Physical examination (results: developmental milestone were within normal range: head circumference: 46 cm) was done on an unspecified date. See related case (s): US WYE H15204410 (adverse event, non expedited) and US WYE H15204510 (adverse event, non expedited). No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Rash
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced rash. The patient received a dose of an unspecified date. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On an unspecified date, the patient experienced rash. The outcome was unknown. See related case (s): US WYE H15128310 (adverse event, non expedited) and US WYE H15204410 (adverse event, non expedited). No additional information was available at the time of this report.
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Additional information provided patient demographics, dose details, suspect vaccine, test results, and outcome. Information regarding PREVNAR was received from a healthcare professional regarding a 4 month old male patient who experienced hives. A 4 months of age, the patient received a dose on 16 Mar 2010. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on 16 Mar 2010. Dose regimen was 1 dose (intramuscular). Additional suspect medication included HIBEST. Concomitant medications were not reported. The patient experienced hives on 27 Mar 2010. The patient recovered. No additional information was available at the time of this report. Physical examination (results: head circumference of 39.5 cm) was done on 25 Nov 2009. Physical examination (results: developmental milestones: with normal range) was done in Mar 2010. No additional information was available at the time of this report.
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A physician reported that a male patient, his grandson, received the second dose of PREVNAR 7, on an unspecified date via unknown route of administration. Additional suspect medication, HIB vaccine, was received via unknown route of administration on the same unknown date. The patient was 4 months old at the time. Concomitant medications were not reported. Relevant medical history includes a fever following the first dose of PREVNAR. The patient experienced a fever to 102 and irritability for 24 hours. The seriousness criteria for these events were none. The outcome of the events at the time of the report was recovered.
Sex: U
Vaccine: PNC
Symptoms: Nonspecific reaction
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced an unknown event. The patient received a dose on an unspecified date. The patient experienced an unknown event (nonspecific reaction). The outcome was not reported. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information regarding PREVNAR  was received from a healthcare professional regarding a patient who was administered the vaccine that was stored at 34 degrees F. The patient received a dose on an unspecified date. The patient was administered the PREVNAR vaccine that was stored at 34 degrees F. No adverse events were reported. No additional information was available at the time of this report.
Age: 0.6
Sex: M
Vaccine: PNC
Symptoms: Cyanosis
Clinical narrative: Information regarding PREVNAR  was received from a healthcare professional regarding a 7 month old male patient who experienced appearing blue when the mother checked on him the nite of vaccination. At 7 months of age, the patient received a dose on 02 Dec 2009. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on 02 Dec 2009. Dose regimen was 0.5 mL 1 time per day (intramuscular). Concomitant medications were not reported. The mother reported to the physician that her baby appeared blue when the mother checked on him the nite of vaccination (cyanosis) on 02 Dec 2009. The event resolved. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Pain
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced more pain after receiving PREVNAR than reported with receipt of MMR vaccine. The patient received a dose on an unspecified date. The patient experienced more pain after receiving PREVNAR than reported with receipt of MMR vaccine. Patient's receiving PREVNAR 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 H15566910 (adverse event, non expedited).
Age: 1.09
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 13 month old male patient who experienced redness and swelling at the injection site palpable area measuring 4.3 by 5 cm. The patient received the fourth dose on 30 Apr 2010. The patient's concurrent illnesses include hypothyroidism, gastrooesophageal reflux disease, wheezing, trisomy 21 and atrial septal defect with a past history of premature baby. Indication for PREVNAR was immunization. Product was administered on 30 Apr 2010. Dose regimen was "5.0 ml" (parenteral). Concomitant therapy included PREVAICD, Albuterol and Lexoxyl. The patient experienced redness at injection site and swelling at the injection site palpable area measuring 4.3 by 5 cm on 30 Apr 2010. The patient was seen by his physician on 03 May 2010, and the injection site swelling and redness was recovering. It was reported that as of 05 May 2010, the patient's injection site redness was recovering and the swelling had resolved. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A physician reported that a male patient, his grandson, received the first of PREVNAR 7, on an unspecified date via unknown route of administration. Additional suspect medication, HIB vaccine, was received via unknown route of administration on the same unknown date. Relevant medical history and concomitant medications were not reported. The patient experienced mild fever. The seriousness criterion for this event was none. The outcome of the event at the time of the report was unknown. Follow-up (27FEB2011): Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: PNC, PPV
Symptoms: Drug administration error, Laboratory test normal, Muscle spasms, Musculoskeletal pain, Neck pain
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 53 year old female patient who experienced pain in shoulder, pain in back of neck, inappropriate use of drug, spasms and swelling to her collar bone. The patient received a dose on 16 Sep 2010. The patient also received a dose of PNEUMOVAX on 16 Sep 2010. The patient's concurrent illnesses included chronic sinusitis and fibromyalgia. Past therapies included PNEUMOVAX . Indication for PREVNAR was immunization. Product was administered on 16 Sep 2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced pain in shoulder, pain in back of neck, inappropriate use of drug, spasms and swelling to her collar bone in 2010. Sometime in 2010, patient saw a rheumatologist and was provided with an unspecified pain medication and went for physical therapy. Because of persisting symptoms, she also went to see an orthopedist who is calling her symptoms neuropathy. As of 18 Oct 2010, the patient's symptoms persist but are less. X ray (results: normal results) and laboratory test (results: unspecified (normal results)) were done in 2010. No additional information was available at the time of this report.
Age: 53.0
Sex: F
Vaccine: PNC, PPV
Symptoms: Swelling, X-ray normal
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 53 year old female patient who experienced pain in shoulder, pain in back of neck, inappropriate use of drug, spasms and swelling to her collar bone. The patient received a dose on 16 Sep 2010. The patient also received a dose of PNEUMOVAX on 16 Sep 2010. The patient's concurrent illnesses included chronic sinusitis and fibromyalgia. Past therapies included PNEUMOVAX . Indication for PREVNAR was immunization. Product was administered on 16 Sep 2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced pain in shoulder, pain in back of neck, inappropriate use of drug, spasms and swelling to her collar bone in 2010. Sometime in 2010, patient saw a rheumatologist and was provided with an unspecified pain medication and went for physical therapy. Because of persisting symptoms, she also went to see an orthopedist who is calling her symptoms neuropathy. As of 18 Oct 2010, the patient's symptoms persist but are less. X ray (results: normal results) and laboratory test (results: unspecified (normal results)) were done in 2010. No additional information was available at the time of this report.
Age: 0.2
Sex: F
Vaccine: PNC
Symptoms: Eczema, Urticaria
Clinical narrative: Information regarding PREVNAR was received from a consumer regarding a 2 month old female patient who experienced eczema and severe hives. The patient received a dose on an unspecified date and a dose on an unspecified date. The patient experienced eczema and severe hives. Outcome was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Drug administered at inappropriate site
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced accidental injected SQ. The patient received a dose on 15 Apr 2010. Relevant medical history was not provided. Indication for PREVNAR was not provided. Product was administered on 15 Apr 2010. Dose regimen was 1 dose 1 time per day (subcutaneous). Concomitant medications were not reported. The patient was accidentally injected SQ in 2010. No adverse events were reported. No additional information was available at the time of this report.
Age: 0.4
Sex: U
Vaccine: PNC
Symptoms: Rash, Urticaria
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 5 month old patient who experienced facial rash and hives. At 5 months of age, the patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified date in 2010, the patient experienced facial rash and hives. Treatment was not reported. On 11 Jun 2010, the patient recovered from the events. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Injection site pain
Clinical narrative: New information was received regarding use of Ethyl Chloride. Information regarding PREVNAR was received from a physician regarding a patient who experienced very painful injection. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication of PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1dose 1 time per day. Concomitant therapy included Ethyl Chloride. The patient experienced very painful injection on an unknown date. Outcome is unknown. Ethyl chloride is used as skin refrigerant or anesthesia to prevent pain at injection site. No additional information was available at the time of this report.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Condition aggravated, Eczema
Clinical narrative: Information regarding PREVNAR (injection) was received from a healthcare professional regarding a 4 month old female patient who experienced exacerbation of eczema. At 4 months of age, the patient received the second dose on 05 Apr 2010. The patient also received the second dose of ROTATEQ (Merck and Co Inc) and the second dose of PENTACEL (Aventis Pasteur) on 05 Apr 2010. On 10 Apr 2010 the patient experienced exacerbation of eczema. The patient was seen by the dermatolgoist. The patient recovered. See related case(s): US WYE H17265110 (adverse event, non expedited) for the same event following administration of PREVNAR 13 at 6 months of age. No additional information was available at the time of this report.