chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Death, Influenza
Clinical narrative: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee On Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. This child was vaccinated completely as per schedule. This child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.
Sex: U
Vaccine: FLUX
Symptoms: Death, Inappropriate schedule of drug administration, Influenza
Clinical narrative: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. The patient was partially vaccinated and did not complete vaccination schedule. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.
Sex: U
Vaccine: FLUX
Symptoms: Death, Influenza
Clinical narrative: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.
Sex: U
Vaccine: FLUX
Symptoms: Death, Influenza
Clinical narrative: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. The child presented with influenza which later lead to death on unknown date.  The causality was not reported.  The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition.  Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion.  Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.
Sex: U
Vaccine: FLUX
Symptoms: Death, Influenza
Clinical narrative: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. It was unknown if the patient was vaccinated completely as per schedule.  The child presented with influenza which later lead to death on unknown date.  The causality was not reported.  The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition.  Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion.  Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.
Sex: U
Vaccine: FLUX
Symptoms: Death, Influenza
Clinical narrative: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. It was unknown if the patient was vaccinated completely as per schedule. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.
Sex: U
Vaccine: FLUX
Symptoms: Death, Influenza
Clinical narrative: Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. It was unknown if the patient was vaccinated completely as per schedule. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Pharyngeal oedema
Clinical narrative: Initial report received from a consumer's attorney on 21 Dec 2010: This patient was vaccinated with seasonal influenza virus vaccine (manufacturer unknown, batch number unknown) on an unspecified date. The patient stated that her throat was swelling up and she had difficulty breathing. She was administered epinephrine injection and taken to hospital. The outcome of the event was not reported.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This is a spontaneous report by a contactable consumer (employee from sales department).  A 3-year-old male child received a dose of PREVNAR 13 via intramuscular injection once as a preventive measure for pneumococcal disease on 07Feb2011.  Relevant medical history, past product history and concomitant medications were not provided.  On 09Feb2011, the patient experienced red patch of 1.5 to 3 inches at the site of injection that was warm and painful.  There was no fever.  Relevant lab data was unknown.  At the time of the report, the patient had recovered from the events in Feb2011.  The caller was not sure whether PREVNAR 13 protein was purchased.
Age: 0.64
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Diarrhoea, Vomiting
Clinical narrative: vomiting and diarrhea at night {3 nights after oral Rotavirus vaccination}
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Chest X-ray, Pneumonia, Pneumonia primary atypical
Clinical narrative: This is an initial spontaneous report from a contactable nurse.  The nurse called for her 3-year-old son who received one shot of PREVNAR 13 on 12Jan2011 at an unknown dose to prevent illness.  The consumer did not have any relevant medical history.  The consumer was not taking any relevant concomitant medications.  It was reported that her son was given PREVNAR 13 vaccine and after that he was diagnosed with walking pneumonia on 18Jan2011.  The consumer was diagnosed with pneumonia on 22Jan2011 and was hospitalized on the same day.  The relevant laboratory work included blood test and chest X-ray however the results were unknown.  The consumer had taken the vaccine for only one time.  Therapeutic measures taken included IV antibiotic fluids and OMNICEF (dose, frequency unknown).  The consumer was recovering at the time of report.
Sex: U
Vaccine: PNC13
Symptoms: Bacterial test positive, Convulsion, Drug ineffective, Fontanelle bulging, Irritability
Clinical narrative: This is a spontaneous report from a non-contactable consumer. It was reported that an unknown patient (sex/age/race unknown) received an unknown number of doses of PREVNAR 13. The medical history and concomitant medications were unknown. On an unknown date or dates, the patient experienced Streptococcal pneumoniae meningitis, drug ineffective, otitis media, seizure, upper respiratory tract infection (URI) with fever, pale, bulging fontanelle, and fussiness. It is unknown if the patient recovered.
Sex: U
Vaccine: PNC13
Symptoms: Meningitis pneumococcal, Otitis media, Pallor, Pyrexia, Streptococcus test positive
Clinical narrative: This is a spontaneous report from a non-contactable consumer. It was reported that an unknown patient (sex/age/race unknown) received an unknown number of doses of PREVNAR 13. The medical history and concomitant medications were unknown. On an unknown date or dates, the patient experienced Streptococcal pneumoniae meningitis, drug ineffective, otitis media, seizure, upper respiratory tract infection (URI) with fever, pale, bulging fontanelle, and fussiness. It is unknown if the patient recovered.
Sex: U
Vaccine: PNC13
Symptoms: Upper respiratory tract infection
Clinical narrative: This is a spontaneous report from a non-contactable consumer. It was reported that an unknown patient (sex/age/race unknown) received an unknown number of doses of PREVNAR 13. The medical history and concomitant medications were unknown. On an unknown date or dates, the patient experienced Streptococcal pneumoniae meningitis, drug ineffective, otitis media, seizure, upper respiratory tract infection (URI) with fever, pale, bulging fontanelle, and fussiness. It is unknown if the patient recovered.
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Blood culture positive, CSF test normal, Pneumococcal bacteraemia, Pyrexia, Streptococcus test positive
Clinical narrative: This is a spontaneous report by a contactable physician. This physician reports a 6 month old female infant started PREVNAR 13 dose unknown, on an unknown date for routine immunizations. Her dose at the onset of events is unknown. Relevant medical history includes the infant was hospitalized with failure to thrive and dehydration on 14Dec2009. Any relevant concomitant medications or drug history is unknown. The infant received an immunization with PREVNAR 13 on 09Jun2010. On an unknown date in Jun2009 (after she received her PREVNAR 13), she was hospitalized for a fever. During that hospitalization a blood culture and sensitivity grew "strep pneumococcal bacterimia" that was "pan-sensitive" the infant also had cerebral spinal fluid studies that were normal. The infant was treated with intravenous ceftirafzone, dose unknown, and then transitioned to AUGMENTIN for 10 days. The infant was discharged after 4 days in the hospital. On 29Jun2010, the infant had an office check up at which she weighed 6.73 kg and was 25.5 inches long, and everything was okay. At the visit on 29Jun2010, the treating physician wrote on the chart that the infant was to have another PREVNAR 13 at her 15 month check up. The infant then changed doctors and the reporter first saw the infant last week in Dec2010 for a well baby check. It is unknown if PREVNAR 13 is being continued.
Age: 3.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Blood test normal, Erythema multiforme, Hypersensitivity, Rash generalised
Clinical narrative: This is a spontaneous report from a contactable consumer. A consumer reports that her 3 year old daughter received a dose of PREVNAR 13 and a dose of a flu with H1N1 vaccine (manufacturer unknown) for her 3-year immunization, intramuscularly, one in each upper arm, on 09Nov2010 at an unknown dose. The patient, with no drug allergy, received three or four previous doses of PREVNAR 7 with no problems, and in 2009, she was given a flu vaccine and nasal H1N1 with no problems. Relevant concomitant medications included vitamins with fluoride. On the morning of 13Nov2010, the patient experienced an allergic reaction as when she woke up, she was covered from head to toe with a rash. She was seen by her physician and was given prednisone and BENADRYL. On 14Nov2010, the patient was seen by her physician again because the rash had not improved and was then taken to the emergency room where she was diagnosed with erythema multiforme and treated with intravenous prednisone and oral diphenhydramine. Basic blood work was taken and results were assumed to be normal. As of 16Nov2010, the erythema multiforme was still ongoing and had not improved. Follow-up (15FEB2011): New information was received from a contactable physician regarding a 3-year-old female patient who received a dose of PREVNAR 13 on 09Nov2010. On 13Nov2010 the patient experienced erythema multiforme. The patient was taken to the emergency room on an unspecified date and treated with steroids. The physician reported the patient is recovering. The physician believes there is a reasonable possibility that the event is related to PREVNAR 13. No concomitant medications. The physicians reported no prior medical history, no relevant drug history, no drug allergies, and no family history. The reported event might be compatible with the known adverse event profile of PREVNAR 13; a causal relationship therefore cannot be excluded.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever 102.0, Leg Pain, no swelling.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a pharmacist on 03 Mar 2011: This patient was vaccinated with FLUVIRIN (batch number 1118076P1) (dose unspecified) intramuscularly on an unknown date. The patient had cellulitis in right arm after receiving vaccine from an unknown date. The patient received a prescription for an antibiotic treatment in the same arm. The outcome of the event was reported as ongoing. The causality of the event was not reported. Follow up report received from the pharmacist on 04 Apr 2011: The patient was vaccinated with FLUVIRIN 0.5 ml dose at left deltoid on 25 Feb 2011. On the same day, the patient was also vaccinated with PNEUMOVAX (batch no: 06512), 0.5 ml, intramuscularly, on left deltoid. The patient experienced redness and swelling in left arm from elbow to shoulder on 26 Feb 2011. The patient recovered from these events on 08 Mar 2011. The reporter assessed the events as serious (medically significant) but no causality assessment was provided.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling and redness at site that increased during the night. Fever of 99-100 degrees. Antibiotics ordered - INVANZ 1000mg IM x 2, AUGMENTIN 875mg 1 po BID x 7 days.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal pain, Pain in extremity
Clinical narrative: Returned to clinic two days post TDAP and placement of TST c/o (L) deltoid up into shoulder & down to hand hurting, not tingling, hurting able to move thumb to fingers open & close fist raise arm. Site without redness but approximately 3" x 3" raised warm to touch area over deltoid.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Mother called 4/15/11 at 11:05am & states "(L) leg (outer thigh) red area (size of baseball). Warm to touch at injection site of KINRIX given on 4/13/11. Recommend BENADRYL 3/4 tsp bid x 1 week. Warm bath or compress & alternate cool compress for 5-10 min. TID. Also follow up on Monday or ASAP if site does not improve. Verbal understanding acknowledged.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh to knee swelling, slightly red, warm to the touch. Treated with: AUGMENTIN 600/5 - 6cc Bid x 7 days. ATARAX 10/5 4cc every 6 hours.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Apnoea, Computerised tomogram head, Differential white blood cell count, Electrocardiogram, Electroencephalogram
Clinical narrative: During the afternoon feeding, the infant had an episode in which he paused in his breathing, had his eyes rolled back in his head, became somewhat pallid and limp.  Mother rubbed the patients stomach and responded within 1 minute to normalcy.  While waiting for EMS to arrive the patient had another episode lasting two minutes.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Full blood count, Gaze palsy, Hypotonia, Metabolic function test, Pallor
Clinical narrative: During the afternoon feeding, the infant had an episode in which he paused in his breathing, had his eyes rolled back in his head, became somewhat pallid and limp.  Mother rubbed the patients stomach and responded within 1 minute to normalcy.  While waiting for EMS to arrive the patient had another episode lasting two minutes.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Respiratory syncytial virus test
Clinical narrative: During the afternoon feeding, the infant had an episode in which he paused in his breathing, had his eyes rolled back in his head, became somewhat pallid and limp.  Mother rubbed the patients stomach and responded within 1 minute to normalcy.  While waiting for EMS to arrive the patient had another episode lasting two minutes.
Age: 1.43
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Electroencephalogram abnormal, Status epilepticus
Clinical narrative: Status epilepticus
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: SOME REDNESS
Age: 3.0
Sex: M
Vaccine: DTAPH, HEPA, VARCEL
Symptoms: Crying, Eye swelling, Flushing, Lethargy, Lip swelling
Clinical narrative: Child suddenly became very flushed, complained of throat hurting very badly. Progress quickly (a few minutes) to significant facial swelling, primarily in his lips and eyes. Crying, lethargy.
Age: 3.0
Sex: M
Vaccine: DTAPH, HEPA, VARCEL
Symptoms: Oropharyngeal pain, Swelling face
Clinical narrative: Child suddenly became very flushed, complained of throat hurting very badly. Progress quickly (a few minutes) to significant facial swelling, primarily in his lips and eyes. Crying, lethargy.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 7X7 CM AREA OF REDNESS, SWELLING, AND TENDERNESS TO TOUCH AT INJECTION SITE.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Headache
Clinical narrative: Head ache & stomach ache. Afebrile, 97.6 O2sat 97%.
Age: 28.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Erythema, Formication, Injection site pruritus, Paraesthesia, Rash
Clinical narrative: 4/13/11 Felt "skin crawling", itching over left upper arm at vaccination site extending from near shoulder to elbow. Discovered rash forming. Seen 4/14/11, maculopapular lesions 28cm by 25 cm, florid red, non-pustular. Lesion itself 1cm by 1 cm (vaccinia site). 4/15/11 seen at clinic with (Rt) cheek tingling & drooping (slight) (Rt) side of mouth. Taking Ibuprofen 400 q 6 hours, ZYRTEC q AM & BENADRYL 50 mgm at HS. To return to clinic 4/18/11 8 am.
Age: 28.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Rash maculo-papular, Skin lesion, VIIth nerve paralysis
Clinical narrative: 4/13/11 Felt "skin crawling", itching over left upper arm at vaccination site extending from near shoulder to elbow. Discovered rash forming. Seen 4/14/11, maculopapular lesions 28cm by 25 cm, florid red, non-pustular. Lesion itself 1cm by 1 cm (vaccinia site). 4/15/11 seen at clinic with (Rt) cheek tingling & drooping (slight) (Rt) side of mouth. Taking Ibuprofen 400 q 6 hours, ZYRTEC q AM & BENADRYL 50 mgm at HS. To return to clinic 4/18/11 8 am.
Age: 28.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Formication, Injection site pruritus, Paraesthesia, Rash erythematous, Rash maculo-papular
Clinical narrative: 4/13/11 Felt "skin crawling", itching over left upper arm at vaccination site extending from near shoulder to elbow. Discovered rash forming. Seen 4/14/11, maculopapular lesions 28cm by 25 cm, florid red, non-pustular. Lesion itself 1cm by 1 cm (vaccinia site). 4/15/11 seen at clinic with (Rt) cheek tingling & drooping (slight) (Rt) side of mouth. Taking Ibuprofen 400 q 6 hours, ZYRTEC q AM & BENADRYL 50 mgm at HS. To return to clinic 4/18/11 8 am.
Age: 28.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Skin lesion, VIIth nerve paralysis
Clinical narrative: 4/13/11 Felt "skin crawling", itching over left upper arm at vaccination site extending from near shoulder to elbow. Discovered rash forming. Seen 4/14/11, maculopapular lesions 28cm by 25 cm, florid red, non-pustular. Lesion itself 1cm by 1 cm (vaccinia site). 4/15/11 seen at clinic with (Rt) cheek tingling & drooping (slight) (Rt) side of mouth. Taking Ibuprofen 400 q 6 hours, ZYRTEC q AM & BENADRYL 50 mgm at HS. To return to clinic 4/18/11 8 am.
Age: 1.49
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site reaction, Rash papular, Skin lesion, Skin plaque
Clinical narrative: Rash noted morning after administration. Rash first noted close to injection site. At first fine red papules on left upper thigh, then spreading to trunk, then appearance of red raised plaques and target lesions on trunk.
Age: 3.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site swelling
Clinical narrative: Noticed swelling, redness, itching of (L) arm the day after vaccines given. Continued to get red and swollen into the second day. On exam extensive area of swelling redness with edema demarcation on (L) arm. ? cellulitis vs local vaccine reaction. Treated with ZITHROMAX 200 mg/5cc 4cc p.o. x 1, then 2cc p.o. x 1 x 4 and ATARAX.
Sex: U
Vaccine: HEPAB
Symptoms: VIIth nerve paralysis
Clinical narrative: This case was reported by a physician and described the occurrence of Bell's Palsy symptoms in an adult subject of unspecified gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown). Within 48 hours after vaccination with TWINRIX, the subject experienced Bell's Palsy symptoms and had to report to the emergency department. The subject was hospitalised.  At the time of reporting the outcome of the event was unspecified.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site rash
Clinical narrative: Rash noted on both thighs where PREVNAR & PENTACEL given had bandaids over site.
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying
Clinical narrative: Inconsolable crying started within 30 minutes of vaccine injections, brief episodes of console. TYLENOL given about 3 - 4 hrs after injections. Crying much improved within 2 hours of TYLENOL. Swaddling helpful.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13
Symptoms: Cyanosis, Pallor, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of cyanosis in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PEDVAXHIB (Merck), PREVNAR (Wyeth Labs) and ROTATEQ (Merck). There were no concurrent medications. On 9 February 2011 at around 12:00 the subject received 1st dose of PEDIARIX at 0.5 ml in the left leg. On 9 February 2011 the subject also received 1st dose of PEDVAXHIB, 1st dose of PREVNAR and 1st dose of ROTATEQ. Seven to 8 hours (on 09 February 2011) after vaccination with PEDIARIX, PEDVAXHIB, PREVNAR and ROTATEQ, the subject experienced cyanosis, fever, pallor and vomiting and had to be taken to the hospital. He was taken to the emergency room. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with PEDIARIX, PEDVAXHIB, PREVNAR and ROTATEQ.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood test, Cyanosis, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of cyanosis in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PEDVAXHIB (Merck), PREVNAR (Wyeth Labs) and ROTATEQ (Merck). There were no concurrent medications. On 9 February 2011 at around 12:00 the subject received 1st dose of PEDIARIX at 0.5 ml in the left leg. On 9 February 2011 the subject also received 1st dose of PEDVAXHIB, 1st dose of PREVNAR and 1st dose of ROTATEQ. Seven to 8 hours (on 09 February 2011) after vaccination with PEDIARIX, PEDVAXHIB, PREVNAR and ROTATEQ, the subject experienced cyanosis, fever, pallor and vomiting and had to be taken to the hospital. He was taken to the emergency room. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with PEDIARIX, PEDVAXHIB, PREVNAR and ROTATEQ.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain
Clinical narrative: Patient called office to report reaction Flu vaccine. Stated that she received shot and immediately had pain, as time progressed she could not lift arm above head. Has had pain since the flu shot but is better now but has some pain at times. Did not go to doctor.
Age: 38.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Chest discomfort, Dyspnoea, Erythema, Induration, Laboratory test
Clinical narrative: Chest tightness with SOB and ears ringing 20 minutes after vaccines administered. Redness to arm after injections. Next day 3-19-11, arm hurting with 4-5" area of arm swollen, hard, and hot. Symptoms lasted until 3-23-11. SOB lasted 2 weeks. Redness up through last week. Area peeling now. Lab work done through Private doctor - lab values affected d/t vaccines per Doctor.
Age: 38.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Oedema peripheral, Pain in extremity, Skin exfoliation, Skin warm, Tinnitus
Clinical narrative: Chest tightness with SOB and ears ringing 20 minutes after vaccines administered. Redness to arm after injections. Next day 3-19-11, arm hurting with 4-5" area of arm swollen, hard, and hot. Symptoms lasted until 3-23-11. SOB lasted 2 weeks. Redness up through last week. Area peeling now. Lab work done through Private doctor - lab values affected d/t vaccines per Doctor.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of MMR injection. On 4-14-2011, site measured 31.2 as reported by Dr.; on 4/5 swelling down to 1 cm not red.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Whelps (R) deltoid at Tdap & MCV4 site & (L) arm where Ch. Px was given.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer Sales Representative. A patient (age, gender, race unspecified) received PREVNAR 13, on an unknown date, at an unspecified dose. Relevant medical history, concomitant medications and past product history were unknown. On an unknown date, following administration of PREVNAR 13, the patient developed pain at the site of injection. At the time of this report, the patient outcome was unknown. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Oropharyngeal pain
Clinical narrative: Initial consumer (patient) report received on 13 Jan 2011: This patient with vaccination history of H1N1 vaccine without any events was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on an unknown date. She experienced mild sore throat and run down feelings on unknown date. The outcome and causality of the events were not reported.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Initial report received from a consumer via the marketing program TOBI care on 14 Feb 2011: This patient started to receive TOBI at 300 mg on an unknown date for CF (cystic fibrosis) and seasonal influenza vaccine (manufacturer and batch number unknown) at an unknown dose on an unknown date for an unspecified indication. It was reported that, the patient had flu shot this season but feels he might have flu now. The outcome of the event was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: Initial consumer report received on 16 Feb 2011: This polymedicated patient with a current condition of "bad back", COPD and emphysema, received Influenza virus vaccine seasonal (manufacturer unknown, batch number unknown) on an unknown date. The patient had a big blue spot on arm which was painful. The patient went to the hospital. The symptoms went away and came again on an unknown date. The patient used warm pad and was taking pain pills. The outcome was not reported.
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Poor quality sleep
Clinical narrative: This is a spontaneous report by a contactable consumer. This female reporter called on behalf of her son who received PREVNAR 13 unknown dose for an unknown reason on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were unknown. In Feb2011 while on PREVNAR 13 her son was not sleeping well and eating like before. Relevant lab data was unknown. At the time of the report it was unknown if her son was taking PREVNAR 13. At time of the report he had not recovered from the above mentioned events.
Age: 1.56
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report received by Pfizer from Merck. This contactable nurse reported that her 18-month-old daughter of unknown ethnicity received a dose of PREVNAR 13 route of administration unknown, for vaccination on 12Nov2010. Medical history and concomitant medications of the patient were unknown. On 12Nov2010 the patient experienced high fever (103.5). The nurse reported that the fever of 103.5 occurred within 12 hours of the vaccination with PREVNAR 13 and lasted for 3 days. Treatment received for the fever included TYLENOL and MOTRIN. At the time of the report clinical outcome of the event was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous reported by a contactable Physician. This Pfizer sales representative reported on behalf of a physician regarding a female patient who received PREVNAR 13, dose unknown, at an unknown time on an unknown anatomical site on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were not reported. Vaccines given on the same day were not specified. Vaccines taken within the last four weeks were unknown. On an unknown date while on an unknown dose of PREVNAR 13 she experienced high fever. Relevant lab data was unknown. At the time of report clinical outcome of the event was unknown. Follow-up (23FEB2011): Follow-up attempts completed. No further information is needed.
Age: 3.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable nurse, who reported for a patient. This 3-year-old (race unknown) male patient started to receive PREVNAR 13 on 15Dec2010 at 0.5cc in his upper left thigh for routine immunization. The relevant medical history of the patient was unknown. The relevant concomitant medication included was an unknown flu vaccine on 15Dec2010 at an unknown dose and frequency. The patient started experiencing red hot swelling in the upper left thigh on an unknown date in Dec2010. The reporter mentioned that the red hot swelling was 6/6 centimeters. The relevant laboratory tests were none. The status of therapy with PREVNAR 13 was unknown at the time of the report. The therapeutic measure taken in response to the event was KEFLEX which was prescribed on 17Dec2010 at 250mg at an unknown frequency. The patient had not recovered at the time of the report. Follow-up attempts completed. No further information expected. Follow-up (08FEB2011): Follow-up attempts completed. No further information is needed.
Age: 3.0
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician. A 3-year-old child was administered PREVNAR 13 via an unknown route of administration, in the left thigh, on 21Sep2010. Relevant medical history, concomitant medications and past product history were not reported. On 23Sep2010, the patient returned to the physician's office exhibiting local hives and substantial swelling and redness (onset date not reported). The parent reported having administered BENADRYL to the child. The physician examined the patient. Following examination of the patient, the physician administered ORAPRED to the child. Subsequently, the parent contacted the physician and stated that it took "about a week" for the redness and swelling to subside. The outcome of the hives was not reported.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional, a mother, reporting on behalf of her 25-month-old daughter who received a dose of PREVANR 13 intramuscular injection on 31Jan2011. Relevant medical history was none. Relevant concomitant medications included vitamins and baby fluoride. Vaccines taken within the last four weeks were none. On 02Feb2011 the patient experienced swelling of her right arm, crying all night, site of administration had become red and raised by two and half inches in diameter and the site of injection had become sensitive to touch. Relevant lab data was none. At the time of the report the patient was recovering from all the above mentioned events.
Age: 10.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 10-year-old female patient received PREVNAR 13 in her arm on 22Jan2011. The patient was also administered another unspecified vaccine in her leg that same day. There was no relevant past medical history and the patient did not have any concomitant medications. On 22Jan2011, following administration of the vaccines, the patient experienced severe pain in her arms. At the time of this report, the outcome of severe pain in her arms was unknown.
Age: 1.5
Sex: U
Vaccine: PNC13
Symptoms: Ear disorder, Sinus disorder
Clinical narrative: This is a spontaneous report from a contactable nurse. An unspecified patient (age and gender unknown) received the fourth dose of PREVNAR 13 on an unknown date at 18 months of age. It was noted that the patient received doses at 2, 4, 6, and 18 months of age. Relevant medical history and concomitant medications were not provided. On an unspecified date, the nurse stated that the patient experienced ear and sinus problems. Laboratory test results were unknown. Outcome was not provided.
Age: 0.19
Sex: M
Vaccine: PNC13, RVX
Symptoms: Skin discolouration
Clinical narrative: This is a spontaneous report by a contactable consumer. This female reported on behalf of her currently 4-month-old son that he began on PREVNAR 13 on left thigh for the treatment of pneumococcal infections on 04Nov2010. Relevant medical history included reflux. Relevant concomitant medications included ranitidine 0.9 mg three times a day for reflux and supplements of vitamin A, vitamin C and vitamin D. Vaccines taken within the last four weeks included ROTAVIRUS in 04Nov2010 and other vaccines were HEPATITIS B in Oct2010, and HEPATITIS B in Sep2010. On 04Nov2010 while on PREVNAR 13 he experienced grey blue V shaped mark on the top layer of dermis which was atypical, not spreading and was maintaining state. Relevant lab data was none. At the time of the report it was unknown if he was taking vaccine. At the time of the report he had not recovered from the grey blue V shaped mark. Follow-up attempts completed. No further information expected.
Age: 2.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This is an initial spontaneous report by a non-contactable physician via a Pfizer Sales Representative. A "little over 2-year-old infant" received the fifth dose of PREVNAR 13 at an unknown time on an unknown anatomical site for an unknown indication on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were unknown. On 15Nov2010 the patient developed a large redness on the arm, red lump on arm, sore arm and arm was swollen. Relevant lab data was unknown. At the time of the report the patient had not recovered from swollen arm. At the time of the report the clinical outcome of all the other events was unknown.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: This is an initial spontaneous report by a contactable consumer. This female consumer reported for her 3 year old son received PREVNAR 13 on 24Nov2010 for the treatment of pneumonia. Relevant medical history was none. Relevant concomitant medications were none. On 26Nov2010, the patient experienced an unspecified reaction. Treatment included prednisone. Relevant tests included blood work performed on 30Nov2010. Results were unknown. Patient not yet recovered at time of report. Follow-up (09FEB2010): New information reported from a contactable physician included the site of the PREVNAR 13 injection (left deltoid), the lot number (914971) with expiration date (3/2012) and the date of the adverse event onset as 25Nov2010. The physician reported this 3-year-old male patient developed a red, swollen area 7" x 5" in size over left deltoid at site of PREVNAR injection; patient later developed hives over feet.  At the time of this report, it is unknown if the patient has recovered.
Sex: U
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced increased pain with PCV13 than with PCV7. The patient received a dose on an unspecified date. The patient experienced increased pain with PCV13 than with PCV7. The outcome for increased pain with PCV13 than PCV7 was not reported. Follow up (05Jan2011): 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. This physician reported that PCV13 causes greater discomfort on administration than any other vaccine. MMR was previously known to be the painful, PCV7 seemed more painful. PCV13 causes more screaming, louder screaming, than any other vaccine. Pediatrician now gives it last due to the response of patients. The physician wanted to know if it can be formulated to decrease the pain. No follow up attempts possible. No further information expected.
Age: 0.62
Sex: M
Vaccine: PNC13
Symptoms: Body temperature increased
Clinical narrative: This is a spontaneous report by a contactable office staff. This office staff person reported on behalf of a physician for a currently 15-month-old male who received PREVNAR 13 0.5ml injection intramuscularly in the morning on left thigh for pneumonia in Jun2010 at the age of 7 months. Relevant medical history was none. Relevant concomitant medication was none. Vaccines given on the same day were none. Vaccines taken within the last four weeks were none. On 07Jun2010 he experienced rise in temperature to 103 degrees Fahrenheit. Therapeutic medication in response to the event was unknown. At the time of the report he had recovered from the above mentioned event in 48 hours.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: 5-7 cm erythema, (L) upper arm, non tender. Tx - OTC hydrocortisone.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Pt's fiance called about 2 hrs later stating her had red welts all over body. Had pt back in office for re-evaluation. Called into pharmacy Prednisone 40 mg 1 daily x 3 days.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Initial physician report received on 22 Nov 2010: This 10-15 patients were vaccinated with MENVEO of unknown batch which were stored between 30 and 40 F for approximately 2 months on unspecified date. Follow up physician report received on 03 Dec 2010: The physician stated that only 6 patients were vaccinated with MENVEO which was stored at 30 F. All the patients were identified. This patient was vaccinated with MENVEO on 16 Oct 2010. No adverse events were reported.