chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Pyrexia
Clinical narrative: This case was considered medically important because it was not sure if either the patient had to be treated at the hospital or was hospitalized.  Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced a high fever.  The patient received a dose on 07-May-2010.  The patient experienced a high fever in May-2010.  It was reported that either the patient had to be treated at the hospital or was hospitalized.  The outcome was unknown.  See related cases(s): US-WYE-H15094610 (adverse event, expedited) and US-WYE-H15093710 (adverse event, expedited).  No additional information was available at the time of this report.  Follow-up (07Dec2010): Following the integration of the legacy safety adverse event reporting database, this case has been migrated from the legacy company database into the current safety database for processing follow-up information.  As a consequence of this migration, the follow-up report may indicate in the appropriate field that it is an initial report.  Spontaneous case from contactactable physician stated patient patient recovered.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia
Clinical narrative: Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database for processing follow-up information. As a consequence of this migration, the follow-up report, VAERS or other company report may indicate in the appropriated field that it is an initial report. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 7-month-old male patient who experienced fever. The patient received the first dose on 07-May-2010 along with a second dose of PENTACEL (Aventis-Pasteur) and ENGERIX B (Smith Kline & French Laboratories). On 08-May-2010, the patient experienced fever and was hospitalized. Treatment was not reported. On an unspecified date, the patient was discharged from the hospital. The outcome of the event was unknown. No additional information was available at the time of this report. Follow-up (06JAN2011): The VAERS annual follow-up was received from the healthcare professional and indicated that the patient had recovered.
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced injection site reactions and high fever. The patient received a dose on an unspecified date. The patient experienced injection site reactions and high fever on an unspecified date. The Physician commented that these events didn't seem to happen with PREVNAR 7. The patient's outcome was not reported. 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 this migration, the follow-up report, other company report or VAERS report may indicate in the appropriate field that it is an initial report. Follow-up(11JAN2011): VAERS Annual follow-up was received from the healthcare professional; the patient recovered.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hypokinesia, Irritability
Clinical narrative: New information in source details, patient details, product details, event details, medical history and test results regarding PREVNAR 13 was received from a nurse regarding a 4-month-old male patient who experienced being extremely irritable and wouldn't move right leg. At 4 months of age, the patient received a dose on 28-Jun-2010. The patient also received a dose of ROTATEQ (Merck & Co Inc) (oral) and a dose of PENTACEL (Aventis-Pasteur) on 28-Jun-2010. The patient experienced being extremely irritable and wouldn't move right leg on 28-Jun-2010. Outcome of the events was recovered. No additional information was available at the time of this report. Follow-up attempts completed. No further information expected. 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 report, other company or VAERS may indicate in the appropriate field that it is an initial report. Follow-up (23FEB2011): New information reported includes: Follow-up was received from the healthcare professional's office. The patient recovered. This is a spontaneous follow-up report from a contactable nurse. The nurse reported the developmental milestones (language/speech; emotional/social; fine/gross motor skills; and cognitive thinking) were all within normal range. The child's physical growth is within normal range. No other relevant history was reported. No other explanation for the events were reported. At the time of this report, the patient has recovered. The nurse stated, but no further PREVNAR injections will be given. Follow-up attempts completed. No further information expected.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea, Gait disturbance, Injected limb mobility decreased, Injection site pain, Irritability
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 2-year-old male patient who experienced fever, pain in leg and difficulty walking. At 2 years of age, the patient received a dose on an unspecified date. The patient experienced fever, pain in leg and difficulty walking due to pain in leg on an unspecified date. Outcomes were not provided. No further information was provided. Follow-up Status: case close (31JAN2011). 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 this migration, the follow-up report or other company report may indicate in the appropriate field that it is an initial report. Follow-up(31Jan2011):This contactable physician reported that a 32-month-old male patient received a dose of PREVNAR 13 on 09 Sep2010 via intramuscular route of administration for immunisation. On 10Sep2010, the patient developed a recurrent fever, no use of leg, leg pain, loose stools x 2, and irritability. The outcome of the events at the time of the report was recovered with sequela on 15Sep2010.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 2-year-old male patient who experienced fever, pain in leg and difficulty walking. At 2 years of age, the patient received a dose on an unspecified date. The patient experienced fever, pain in leg and difficulty walking due to pain in leg on an unspecified date. Outcomes were not provided. No further information was provided. Follow-up Status: case close (31JAN2011). 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 this migration, the follow-up report or other company report may indicate in the appropriate field that it is an initial report. Follow-up(31Jan2011):This contactable physician reported that a 32-month-old male patient received a dose of PREVNAR 13 on 09 Sep2010 via intramuscular route of administration for immunisation. On 10Sep2010, the patient developed a recurrent fever, no use of leg, leg pain, loose stools x 2, and irritability. The outcome of the events at the time of the report was recovered with sequela on 15Sep2010.
Sex: U
Vaccine: 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 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. 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 this migration, the follow-up report, other company report or VAERS report may indicate in the appropriate field that it is an initial report. Follow-up(10Feb2011): VAERS annual follow-up was received from a healthcare professional' s office: the patient recovered.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Swelling
Clinical narrative: Initial report received from vaccine adverse event reporting system website (VAERS reference number 402196) on 30 Nov 2010: This patient received MENVEO (batch number not known) unknown dose in left arm on 28 Sep 2010. On 29 Sep 2010, the patient developed erythema and swelling in surrounding area. When area was 8.5 x 10 cm in size, the patient started diphenhydramine 25 mg every 6 hours. Eighteen hours later on 30 Sep 2010, area was more swollen and red (13 x 17 cm). The patient continued with BENADRYL and started prednisone. The outcome was not reported.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Asthenia, Body temperature increased, Chills, Diarrhoea
Clinical narrative: Initial report received from vaccine adverse event reporting system website (VAERS reference number 407535) on 31 Dec 2010: This patient with an unknown medical history was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on unknown date. The patient experienced severe chills, stomach pain, diarrhoea, shallow breathing (breathing at a faster rate than normal), increased heart rate, hoarseness, weakness and became pale on unknown date. The patient felt that he was going to faint but didn't. After a while the patient did not have any chills. He took temperature several times but the highest reading was 100.1 degree Celsius. The patient was concomitant using PROTONIX and Vitamin C at the time of vaccination. The patient stated that he had pork for dinner prior to events, and thought it might have caused the reactions.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dysphonia, Heart rate increased, Hypopnoea, Pallor
Clinical narrative: Initial report received from vaccine adverse event reporting system website (VAERS reference number 407535) on 31 Dec 2010: This patient with an unknown medical history was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on unknown date. The patient experienced severe chills, stomach pain, diarrhoea, shallow breathing (breathing at a faster rate than normal), increased heart rate, hoarseness, weakness and became pale on unknown date. The patient felt that he was going to faint but didn't. After a while the patient did not have any chills. He took temperature several times but the highest reading was 100.1 degree Celsius. The patient was concomitant using PROTONIX and Vitamin C at the time of vaccination. The patient stated that he had pork for dinner prior to events, and thought it might have caused the reactions.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory rate increased
Clinical narrative: Initial report received from vaccine adverse event reporting system website (VAERS reference number 407535) on 31 Dec 2010: This patient with an unknown medical history was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on unknown date. The patient experienced severe chills, stomach pain, diarrhoea, shallow breathing (breathing at a faster rate than normal), increased heart rate, hoarseness, weakness and became pale on unknown date. The patient felt that he was going to faint but didn't. After a while the patient did not have any chills. He took temperature several times but the highest reading was 100.1 degree Celsius. The patient was concomitant using PROTONIX and Vitamin C at the time of vaccination. The patient stated that he had pork for dinner prior to events, and thought it might have caused the reactions.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain of skin, Rash, Skin swelling
Clinical narrative: Initial report received from vaccine adverse event reporting system website (VAERS reference number 410887) on 01 Feb 2011: This patient who was allergic to molds, trees and grass was vaccinated with first dose of RABAVERT (batch number: unknown) on unspecified date. Within one week after vaccination the patient developed swollen patches of red skin in circular pattern on the neck. She was then vaccinated with influenza vaccine (manufacturer and batch number: unknown) on 22 Oct 2010. Later, the rash spread down to torso and was more pronounced during exercise. The skin would sting and turn red during sweating. The outcome was not reported.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Pyrexia, Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician received via a company sales representative. A 2-year-old female patient received the first dose of PREVNAR 13 on 09Dec2010, by intramuscular route of administration, as reported by a contactable nurse practitioner. The physician reported that the patient had been administered all four doses of PREVNAR, at her 2, 4, 6 and 12 month visits. A second dose of Hepatitis A vaccination was also administered on 09Dec2010. The physician reported that the patient experienced fever and hives. The nurse reported that the onset of fever and hives was 10Dec2010. The patient was treated with Prednisone, ZANTAC, and BENADRYL. The nurse reported that the events had resolved on an unknown date. Follow up (PRD/SRD 15Feb2011): New information reported from a contactable nurse practitioner includes: date of birth, route of administration, onset date of adverse event, outcome, causal relationship. Follow up attempts completed. No further information expected. Company Clinical Evaluation comment: Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of the suspect product.
Age: 0.61
Sex: F
Vaccine: MNQ, MNQ
Symptoms: No adverse event
Clinical narrative: Initial report received from a nurse on 09 Dec 2010: This 6 month old patient was vaccinated with MENVEO (batch number 024011) intramuscularly on 09 Dec 2010. No adverse event reported following this administration.
Sex: F
Vaccine: MNQ, MNQ
Symptoms: No adverse event
Clinical narrative: Initial report received from a vaccine adverse event reporting system website (VAERS reference number 412527) on 01 Feb 2011: This patient was supposed accidentally vaccinated with MENVEO (batch number unknown) instead of HIB vaccine (manufacturer and batch number unknown) on 09 Dec 2010. HIB vaccine was ordered. No adverse event reported.
Sex: F
Vaccine: MNQ
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Initial health authority report (VAERS no: 413351) received on 01 Feb 2011: This patient was vaccinated with MENVEO (batch number not reported) on an unspecified date. On an unspecified date, the patient developed cellulitis (of dimension 5 x 2 cms) and erythema in the right deltoid. The patient was treated with AUGMENTIN. The outcome of the event was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial report received from a vaccine adverse event reporting system website (VAERS reference number 413474) on 01 Feb 2011: This patient was vaccinated with only liquid conjugate component of MENVEO (batch number unknown) without being diluted with powder component on an unspecified date. No adverse event reported.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC13, DTAPHEPBIP, RV5
Symptoms: Brain stem auditory evoked response, Computerised tomogram head, Convulsion, Deafness, Drug ineffective
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-month-old patient who experienced drug ineffective and meningitis. The patient received a dose in 2010. The patient experienced meningitis and drug ineffective on an unspecified date in 2010 after receiving PREVNAR therapy. Patient was hospitalized and as of 21-Sep-2010, the nurse indicated that the child was doing ok, but it was unknown if the patient recovered. No further information was provided. Follow-up (13Dec2010): 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 this migration, the follow-up report may indicate in the appropriate field that it is an initial report. New information reported from a contactable nurse included: On 04Aug2010 the patient received PREVNAR 13 lot # E57642, IM in the left leg. On the same day the patient also received HIB vaccine made by pasteur lot# UH125AB IM in the right leg. On 17Aug2010 the patient received PEDIARIX (GSK) lot #AC21B249AA IM in the right leg and on the same day received ROTATEQ (Merck) lot# 0500z orally. Illness at the time of the vaccination included hematochezia, possible cow's milk protein allergy. Patient experienced URI with fever on 17Sep2010. On 18Sep2010 the patient's condition worsened with fussiness, pale, bulging fontanel and otitis media. On 19Sep2010 the patient had strep pneumo meningitis and experienced a seizure on the same date. Patient was hospitalized for 14 days. Patient current weight is 7.4 kg. At the time of the event, Patient was a 3 month old male with birth weight of 8 lbs 7 oz with head circumference of 36.1cm and length of 52.1 cm. Gestational age at delivery is 40 weeks. Relevant prenatal history includes C-section for failure to progress and fetal distress. The vaccine was administered by a healthcare professional. Medication was stored appropriately and not altered in any way. Patient's developmental milestones and physical growth are all normal. Patient is recovering from the events with mild hearing loss. Follow-up attempts completed. No further information expected. Follow-up (10FEB2011): New information reported from Product Quality includes the product quality results. QA results were within specifications.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC13, DTAPHEPBIP, RV5
Symptoms: Electroencephalogram, Fontanelle bulging, Irritability, Laboratory test, Lumbar puncture
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-month-old patient who experienced drug ineffective and meningitis. The patient received a dose in 2010. The patient experienced meningitis and drug ineffective on an unspecified date in 2010 after receiving PREVNAR therapy. Patient was hospitalized and as of 21-Sep-2010, the nurse indicated that the child was doing ok, but it was unknown if the patient recovered. No further information was provided. Follow-up (13Dec2010): 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 this migration, the follow-up report may indicate in the appropriate field that it is an initial report. New information reported from a contactable nurse included: On 04Aug2010 the patient received PREVNAR 13 lot # E57642, IM in the left leg. On the same day the patient also received HIB vaccine made by pasteur lot# UH125AB IM in the right leg. On 17Aug2010 the patient received PEDIARIX (GSK) lot #AC21B249AA IM in the right leg and on the same day received ROTATEQ (Merck) lot# 0500z orally. Illness at the time of the vaccination included hematochezia, possible cow's milk protein allergy. Patient experienced URI with fever on 17Sep2010. On 18Sep2010 the patient's condition worsened with fussiness, pale, bulging fontanel and otitis media. On 19Sep2010 the patient had strep pneumo meningitis and experienced a seizure on the same date. Patient was hospitalized for 14 days. Patient current weight is 7.4 kg. At the time of the event, Patient was a 3 month old male with birth weight of 8 lbs 7 oz with head circumference of 36.1cm and length of 52.1 cm. Gestational age at delivery is 40 weeks. Relevant prenatal history includes C-section for failure to progress and fetal distress. The vaccine was administered by a healthcare professional. Medication was stored appropriately and not altered in any way. Patient's developmental milestones and physical growth are all normal. Patient is recovering from the events with mild hearing loss. Follow-up attempts completed. No further information expected. Follow-up (10FEB2011): New information reported from Product Quality includes the product quality results. QA results were within specifications.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC13, DTAPHEPBIP, RV5
Symptoms: Meningitis pneumococcal, Nuclear magnetic resonance imaging brain, Otitis media, Pallor, Pyrexia
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-month-old patient who experienced drug ineffective and meningitis. The patient received a dose in 2010. The patient experienced meningitis and drug ineffective on an unspecified date in 2010 after receiving PREVNAR therapy. Patient was hospitalized and as of 21-Sep-2010, the nurse indicated that the child was doing ok, but it was unknown if the patient recovered. No further information was provided. Follow-up (13Dec2010): 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 this migration, the follow-up report may indicate in the appropriate field that it is an initial report. New information reported from a contactable nurse included: On 04Aug2010 the patient received PREVNAR 13 lot # E57642, IM in the left leg. On the same day the patient also received HIB vaccine made by pasteur lot# UH125AB IM in the right leg. On 17Aug2010 the patient received PEDIARIX (GSK) lot #AC21B249AA IM in the right leg and on the same day received ROTATEQ (Merck) lot# 0500z orally. Illness at the time of the vaccination included hematochezia, possible cow's milk protein allergy. Patient experienced URI with fever on 17Sep2010. On 18Sep2010 the patient's condition worsened with fussiness, pale, bulging fontanel and otitis media. On 19Sep2010 the patient had strep pneumo meningitis and experienced a seizure on the same date. Patient was hospitalized for 14 days. Patient current weight is 7.4 kg. At the time of the event, Patient was a 3 month old male with birth weight of 8 lbs 7 oz with head circumference of 36.1cm and length of 52.1 cm. Gestational age at delivery is 40 weeks. Relevant prenatal history includes C-section for failure to progress and fetal distress. The vaccine was administered by a healthcare professional. Medication was stored appropriately and not altered in any way. Patient's developmental milestones and physical growth are all normal. Patient is recovering from the events with mild hearing loss. Follow-up attempts completed. No further information expected. Follow-up (10FEB2011): New information reported from Product Quality includes the product quality results. QA results were within specifications.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC13, DTAPHEPBIP, RV5
Symptoms: Upper respiratory tract infection
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-month-old patient who experienced drug ineffective and meningitis. The patient received a dose in 2010. The patient experienced meningitis and drug ineffective on an unspecified date in 2010 after receiving PREVNAR therapy. Patient was hospitalized and as of 21-Sep-2010, the nurse indicated that the child was doing ok, but it was unknown if the patient recovered. No further information was provided. Follow-up (13Dec2010): 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 this migration, the follow-up report may indicate in the appropriate field that it is an initial report. New information reported from a contactable nurse included: On 04Aug2010 the patient received PREVNAR 13 lot # E57642, IM in the left leg. On the same day the patient also received HIB vaccine made by pasteur lot# UH125AB IM in the right leg. On 17Aug2010 the patient received PEDIARIX (GSK) lot #AC21B249AA IM in the right leg and on the same day received ROTATEQ (Merck) lot# 0500z orally. Illness at the time of the vaccination included hematochezia, possible cow's milk protein allergy. Patient experienced URI with fever on 17Sep2010. On 18Sep2010 the patient's condition worsened with fussiness, pale, bulging fontanel and otitis media. On 19Sep2010 the patient had strep pneumo meningitis and experienced a seizure on the same date. Patient was hospitalized for 14 days. Patient current weight is 7.4 kg. At the time of the event, Patient was a 3 month old male with birth weight of 8 lbs 7 oz with head circumference of 36.1cm and length of 52.1 cm. Gestational age at delivery is 40 weeks. Relevant prenatal history includes C-section for failure to progress and fetal distress. The vaccine was administered by a healthcare professional. Medication was stored appropriately and not altered in any way. Patient's developmental milestones and physical growth are all normal. Patient is recovering from the events with mild hearing loss. Follow-up attempts completed. No further information expected. Follow-up (10FEB2011): New information reported from Product Quality includes the product quality results. QA results were within specifications.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC13, DTAPHEPBIP, RV5
Symptoms: Meningitis, Meningitis pneumococcal, Nuclear magnetic resonance imaging brain, Otitis media, Pallor
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-month-old patient who experienced drug ineffective and meningitis. The patient received a dose in 2010. The patient experienced meningitis and drug ineffective on an unspecified date in 2010 after receiving PREVNAR therapy. Patient was hospitalized and as of 21-Sep-2010, the nurse indicated that the child was doing ok, but it was unknown if the patient recovered. No further information was provided. Follow-up (13Dec2010): 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 this migration, the follow-up report may indicate in the appropriate field that it is an initial report. New information reported from a contactable nurse included: On 04Aug2010 the patient received PREVNAR 13 lot # E57642, IM in the left leg. On the same day the patient also received HIB vaccine made by pasteur lot# UH125AB IM in the right leg. On 17Aug2010 the patient received PEDIARIX (GSK) lot #AC21B249AA IM in the right leg and on the same day received ROTATEQ (Merck) lot# 0500z orally. Illness at the time of the vaccination included hematochezia, possible cow's milk protein allergy. Patient experienced URI with fever on 17Sep2010. On 18Sep2010 the patient's condition worsened with fussiness, pale, bulging fontanel and otitis media. On 19Sep2010 the patient had strep pneumo meningitis and experienced a seizure on the same date. Patient was hospitalized for 14 days. Patient current weight is 7.4 kg. At the time of the event, Patient was a 3 month old male with birth weight of 8 lbs 7 oz with head circumference of 36.1cm and length of 52.1 cm. Gestational age at delivery is 40 weeks. Relevant prenatal history includes C-section for failure to progress and fetal distress. The vaccine was administered by a healthcare professional. Medication was stored appropriately and not altered in any way. Patient's developmental milestones and physical growth are all normal. Patient is recovering from the events with mild hearing loss. Follow-up attempts completed. No further information expected. Follow-up (10FEB2011): New information reported from Product Quality includes the product quality results. QA results were within specifications.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC13, DTAPHEPBIP, RV5
Symptoms: Pyrexia, Upper respiratory tract infection
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-month-old patient who experienced drug ineffective and meningitis. The patient received a dose in 2010. The patient experienced meningitis and drug ineffective on an unspecified date in 2010 after receiving PREVNAR therapy. Patient was hospitalized and as of 21-Sep-2010, the nurse indicated that the child was doing ok, but it was unknown if the patient recovered. No further information was provided. Follow-up (13Dec2010): 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 this migration, the follow-up report may indicate in the appropriate field that it is an initial report. New information reported from a contactable nurse included: On 04Aug2010 the patient received PREVNAR 13 lot # E57642, IM in the left leg. On the same day the patient also received HIB vaccine made by pasteur lot# UH125AB IM in the right leg. On 17Aug2010 the patient received PEDIARIX (GSK) lot #AC21B249AA IM in the right leg and on the same day received ROTATEQ (Merck) lot# 0500z orally. Illness at the time of the vaccination included hematochezia, possible cow's milk protein allergy. Patient experienced URI with fever on 17Sep2010. On 18Sep2010 the patient's condition worsened with fussiness, pale, bulging fontanel and otitis media. On 19Sep2010 the patient had strep pneumo meningitis and experienced a seizure on the same date. Patient was hospitalized for 14 days. Patient current weight is 7.4 kg. At the time of the event, Patient was a 3 month old male with birth weight of 8 lbs 7 oz with head circumference of 36.1cm and length of 52.1 cm. Gestational age at delivery is 40 weeks. Relevant prenatal history includes C-section for failure to progress and fetal distress. The vaccine was administered by a healthcare professional. Medication was stored appropriately and not altered in any way. Patient's developmental milestones and physical growth are all normal. Patient is recovering from the events with mild hearing loss. Follow-up attempts completed. No further information expected. Follow-up (10FEB2011): New information reported from Product Quality includes the product quality results. QA results were within specifications.
Age: 25.0
Sex: F
Vaccine: ANTH, TDAP, TYP
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: 2 ERYTHEMATOUS BANDS WITH MILD EDEMA DISTAL TO INJECTION SITES, PRURITIC. TOP BAND MEASURED ~3CM IN WIDTH, BOTTOM 2CM IN WIDTH. PT WAS GIVEN 12.5 OF BENADRYL IM WITH RESOLUTION OF SYMPTOMS
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Pyrexia, Rash
Clinical narrative: Rash (L) arm several days - red large & hard with fever 102. BACTRIM.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying
Clinical narrative: Inconsolable crying x 3 hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, PNC
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Moderate swelling and erythema down arm and into shoulder. Warm and hard to the touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, PNC
Symptoms: Swelling
Clinical narrative: Moderate swelling and erythema down arm and into shoulder. Warm and hard to the touch.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse rxn. Pt received one xtra MMR she did not need. Pt record indicated need for #2 MMR & NP didn't check other site in EMR that had record of all previous immunizations that is clearly read only scanned the flow sheet in order to interpret # 2 MMR had been given 6/20/2003.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a 74 year old male patient with no drug reactions or allergies and no pertinent medical history who on 09-MAR-2011 was vaccinated intramuscularly in the right arm with 0.5 mL of PNEUMOVAX 23 (Lot # 668008/1157Z, expiration: 08-MAR-2012). Concomitant therapy included Lisinopril (manufacturer unknown). On 09-MAR-2011 the patient experienced soreness and trouble raising his right arm. A MRI of right shoulder was performed on an unspecified date, results were pending. Patient sought medical attention. No treatment was given for this adverse event. At the time of reporting the patient had not recovered. Soreness and trouble raising his right arm was considered disabling by medical assistant. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: dizziness
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a registered nurse who "heard" about a female patient that was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported) and developed seizures which reoccured. The female did not have seizures prior to the vaccination. Nurse stated this did not happen at her medical facility and she had no other information regarding this event. The patient's outcome was unknown. Upon internal review seizure was considered to be other important medical event. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abortion induced, Drug exposure during pregnancy, No adverse event, Ultrasound scan, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 15 year old pregnant female with no previous pregnancies, no medical history and no known drug allergies who on 22-JUN-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # 1487Y). The patient also was administered MENACTRA during the same visit. No adverse effect reported. The urine pregnancy test was performed and the result was positive. Ultrasound was performed on an unknown date and the result was unknown. The patient's LMP was 25-MAY-2010 (also reported as 26-MAY-2010) and estimated delivery date was 01-MAR-2011. The outcome of the patient's pregnant was unknown. Follow-up information has been received from the healthcare who reported that the pregnancy was terminated. Upon internal review, pregnancy terminated was considered to be an other important medical event. Additional information has been requested. This is an amended report, SAE "pregnancy terminated" was added. "Upon internal review, pregnancy terminated was considered to be an other important medical event." Was added to narrative.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abscess sterile
Clinical narrative: Information has been received from a registered nurse concerning a "11 or 12 years old" female patient who "about a year ago" (in approximately 2010), was vaccinated with a dose of GARDASIL 0.5 ml, intramuscularly (expiration date and lot number not reported). "About a year ago" (in approximately 2010), the patient experienced a sterile abscess after she received GARDASIL. The patient was hospitalized "duration and location were unspecified". The patient received "unspecified" treatment for the event. Therapy with GARDASIL was discontinued. Therapy was not reintroduced. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Amnesia, Fall, Head injury, Loss of consciousness, Speech disorder
Clinical narrative: Information has been received from a registered nurse concerning a female patient who in March 2011 "sometime in March" was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly (Lot number not reported).  Concomitant therapy included DTAP (unspecified).  The nurse reported that in March 2011 "sometime in March" after received the first dose of GARDASIL intramuscularly, the patient experienced passing out, falling and hitting her head.  She was taken to an unspecified hospital, received unspecified treatment and stayed there for an unspecified duration.  The patient had been released from the hospital and was currently having speech problems and had short term memory loss.  Therapy with GARDASIL was discontinued.  At the time of the report, outcome of the patient was unknown.  It was reported that the patient was not reintroduced to the therapy.  Passing out, fall, hitting her head, speech problems and short term memory loss were considered to be disabling.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture, Local swelling, Lumbar puncture, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient, with a history of rhinitis and sinusitis and no drug reactions or allergies reported, who on 01-APR-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot #: 665300/1314Y, Exp: 08-may-2011), 0.5 ml, intramuscularly. There were no concomitant medications reported. The physician reported that on 02-APR-2011, after receiving PNEUMOVAX 23, the patient was admitted to the hospital. She had fever and localized swelling. The patient was given antibiotics in the hospital as treatment for the event. Blood cultures and spinal tap were performed (Results not provided). Physician would like a lot check for this product. A lot check has been initiated. At the time of the report, the patient's outcome was recovering. This is one of several reports from the same source. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Patient described symptoms of swelling the next day. She also c/o achiness at site & was taking Ibuprofen. On 4/8/11, she stopped in office to show how much it had swollen (4"x2") was red & raised. Suggested she take BENADRYL/apply ice.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: 4 mo old female who had PCV 13 IM in left anterior thigh and PENTACEL IM in right anterior thigh on 4/12/11. Within 24 hrs after vaccines mom noticed multiple bumps with redness on both thighs that spread superiorly. No problems breathing, no lip or tongue swelling, no itching, no fevers. Pt received these vaccines 2 months ago without problems.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site rash, Rash papular
Clinical narrative: 4 mo old female who had PCV 13 IM in left anterior thigh and PENTACEL IM in right anterior thigh on 4/12/11. Within 24 hrs after vaccines mom noticed multiple bumps with redness on both thighs that spread superiorly. No problems breathing, no lip or tongue swelling, no itching, no fevers. Pt received these vaccines 2 months ago without problems.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Pain, Pruritus, Swelling
Clinical narrative: Approximately 11 1/2 mm red, raised, hard, itchy, painful area. Instructed to ice & give antihistamine and TYLENOL/MOTRIN for pain and swelling.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death
Clinical narrative: Mother had + HSV, gestational diabetes and protein  S deficiency.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Papule, Polymerase chain reaction, Pruritus, Rash, Skin lesion
Clinical narrative: Developed rash post SPV vaccination. Started as 3 tiny bumps, then progressed. Went to ED on the 7th re the appearance of additional lesions on trunk and extremities associated with itching. Allergy consulted and pt given antihistamines. Vaccinia PCR obtained. Seen in F/u on 11 Apr. Current lesions clearing, however new lesions developing. Scattered 2-3 mm papules on arms, legs, chest, and back. No drainage, no systemic symptoms. Steroid burst started. F/U call on 15 Apr notes that lesions have almost completely resolved, no new lesions appearing. Continues to feel well.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Neck pain, Pyrexia
Clinical narrative: 4/5/11 per pt a few hrs after immuz given noted - pain (L) upper arm & neck - later after midnight began to have fever. On 4-5-11 also began to note swelling of (L) upper arm from inj site to elbow. Pt contacted MD office 4-6-11 with sx refused Urgent Care visit seen by MD 4-7-11.
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Irritability, Pyrexia
Clinical narrative: High fever and irritability the night of the vaccines.
Age: 72.0
Sex: M
Vaccine: FLU3, MMR, PPV, TDAP
Symptoms: Chills, Depression, Fatigue, Nightmare, Pyrexia
Clinical narrative: After pt got several of vaccines for travel he developed that evening nightmares x 1 night & fever & chills & fatigue & "depression" until 2am 4/12/11. At 4/12/11 visit, pt says he felt normal again.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling 3 1/2 round. Red warm to touch.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Axillary pain, Herpes zoster, Pain
Clinical narrative: Given flu shot 9/21/10 (treated for sinusitis 9/16/10 but afebrile of 9/21/10). Returned 9/27/10 c/o pain on (R) side but under arm (not at flu shot site) that he said started day after flu shot & so thought soreness was due to it. Had herpes zoster on (R) back & under (R) arm 9/27/10.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Red, warm, itchy area, non tender 9x10 cm.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Patient started to develop blister-like eruptions on facial area above lip and on right side of nose, starting on 4/4/11 (3 days following vaccination). She was advised to consult Primary Care Physician for treatment after reporting to pharmacy on 4/6.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: ZOSTAVAX was administered to patient on 3/23/11. After a couple of days, the patient notice a red rash (2 inches in diameter) & was itchy. It got better over time. The pharmacist checked the rash after 2 weeks, the rash is still present, (1.5 inches in diameter) and no longer itchy.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Paraesthesia, Rash generalised
Clinical narrative: After a month of vaccine adm. pt complained of rash and tingling sensation all over his body. The pharmacist advised the pt to see a doctor. He went to see his PCP & PCP said he doesn't have shingles. Now patient is complaining joint pain and is convinced its from shingles shot.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Bilat, transient, itchy rash on hands, thighs & shoulders. Only lasted < 24 hours.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Patient's wife brought in Rx for PERCOCET and Cephalexin. She said sx red, warm, very swollen and painful. She said Rx for cephalexin was "just in case".
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site swelling, Pain, Swelling
Clinical narrative: Patient reported to school nurse 4/1/11. Started swelling late at night on night of vaccination. Sore to touch. Measured site for range of swelling. Measured 3" x 3" across 3 x 2.5 length.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: I broke out in bumps all over my body which turn to sore they gave me DERMA-SMOOTHE-FS body oil and my insurance won't pay for it.
Age: 1.26
Sex: F
Vaccine: DTAPIPVHIB, HEP
Symptoms: Ataxia, Full blood count normal, Irritability, Pyrexia, Streptococcus test negative
Clinical narrative: Irritable and fever from 100.8-105.6 since 4/9/11. Extreme fussiness. Ataxic gait at times.
Age: 1.26
Sex: F
Vaccine: DTAPIPVHIB, HEP
Symptoms: Urine analysis normal
Clinical narrative: Irritable and fever from 100.8-105.6 since 4/9/11. Extreme fussiness. Ataxic gait at times.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Decreased appetite, Dizziness, Hypersomnia, Mass
Clinical narrative: Dizziness & coughing, nausea, slept most of day 4/6/11. 4/7/11 family member took to ER in AM with same symptoms, also knot on Lt arm. Says was given a shot in ER an& has slept most of the week with no appetite.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Dizziness & coughing, nausea, slept most of day 4/6/11. 4/7/11 family member took to ER in AM with same symptoms, also knot on Lt arm. Says was given a shot in ER an& has slept most of the week with no appetite.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Lt deltoid - dark red, warm to touch, firm & woody, tender to palpation, cellulitis, headache. Rt mid-humerus 4 cm area of induration that is blanchable & pruritic/tx with AUGMENTIN and ORAPRED.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: Lt deltoid - dark red, warm to touch, firm & woody, tender to palpation, cellulitis, headache. Rt mid-humerus 4 cm area of induration that is blanchable & pruritic/tx with AUGMENTIN and ORAPRED.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Patient returned to office c/o left upper arm red, swollen, tender, painful x 2 days. Fevers and nausea associated also. Patient was seen by Dr. and prescribed BENADRYL and KEFLEX.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea, Fatigue, Respiratory disorder, Wheezing
Clinical narrative: Respiratory reactions, trouble breathing, wheezing, SOB, fatigue, chest pains.
Age: 63.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Pt c/o lump size between a walnut and a lemon at site of injection. Achy and painful. Advised pt per Dr. to ice the site, take TYLENOL or ibuprofen and BENADRYL as needed. Pt to call office if any new or persisting sx occur.
Sex: M
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site mass, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician. A male patient (age unknown) received a dose of PREVENAR 13 on 23Dec2010 in his right thigh. The patient was also administered SYNAGIS on 23Dec2010 for RSV prophylaxis. Relevant medical history and concomitant medications were not provided. The patient's mother noted swelling at the injection area in the immediate period following the vaccine. Within 7-10 days of the vaccine being administered, the area became very noticeable. It was described as a large mass in the right thigh that had slightly grown since the vaccine was administered. The reporting physician feels he has possibly ruled out SYNAGIS as the cause of the mass due to zero reports of injection site reactions from the manufacturer of SYNAGIS. The reporting physician stated that this mass does not display the typical injection site reactions so they are unsure if it could potentially be a sarcoma they are dealing with. The patient has a consultation scheduled with an orthopedic surgeon on 12APR2011 and he may have an MRI at that time. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of the suspect product.