chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PNC, PNC, PNC, PNC, PNC
Symptoms: No therapeutic response, Otitis media, Platelet count increased, Therapeutic response decreased
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a male patient who experienced otitis media.  The patient completed his primary series, having received a fourth dose on 29-Oct-2003.  The patient has a past history of otitis media (Nov-2004, Apr-2005, Nov-2005 and Jan-2006 (recovered)).  See related cases HQWYE105409MAY07, HQWYE105509MAY07, HQWYE105609MAY07 and HQWYE105709MAY07).  Product was administered on 29-Oct-2003.  Concomitant medications were not reported.  On 29-Oct-2003, the patient received a fourth dose of PREVNAR completing his primary series.  In Feb-2006, the patient experienced otitis media.  On an unspecified date, the patient recovered.  See related case(s): HQWYE062008MAY07 (adverse event, expedited); HQWYE105409MAY07 (adverse event, non-expedited); HQWYE105509MAY07 (adverse event, expedited); HQWYE105609MAY07 (adverse event, expedited); and HQWYE105709MAY07 (adverse event, expedited).  No additional information was available at the time of this report.
Sex: M
Vaccine: PNC, PNC, PNC, PNC, PNC
Symptoms: Otitis media
Clinical narrative: Information regarding PREVNAR (unspec) was received from a healthcare professional regarding a male patient who experienced otitis media. The patient completed his primary series, having received a fourth dose on 29-Oct-2003. The patient has a past history of otitis media (Nov-2004 (recovered) See related case HQWYE105409MAY07); Product was administered on 29-Oct-2003. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 29-Oct-2003, the patient received a fourth dose of PREVNAR, completing his primary series. In Apr-2005, the patient experienced otitis media. On an unspecified date, the patient recovered. See related case(s): HQWYE062008MAY07 (adverse event, expedited); HQWYE105409MAY07 (adverse event, expedited); HQWYE105609MAY07 (adverse event, expedited); HQWYE105709MAY07 (adverse event, expedited); and HQWYE105809MAY07 (adverse event, expedited). No additional information was available at the time of this report.
Sex: M
Vaccine: PNC, PNC, PNC, PNC, PNC
Symptoms: Condition aggravated, Otitis media
Clinical narrative: Information regarding PREVNAR (unspec) was received from a healthcare professional regarding a male patient who experienced otitis media. The patient completed his primary series, having received a fourth dose on 29-Oct-2003. The patient has a past history of otitis media (Nov-2004 (recovered) See related case HQWYE105409MAY07); Product was administered on 29-Oct-2003. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 29-Oct-2003, the patient received a fourth dose of PREVNAR, completing his primary series. In Apr-2005, the patient experienced otitis media. On an unspecified date, the patient recovered. See related case(s): HQWYE062008MAY07 (adverse event, expedited); HQWYE105409MAY07 (adverse event, expedited); HQWYE105609MAY07 (adverse event, expedited); HQWYE105709MAY07 (adverse event, expedited); and HQWYE105809MAY07 (adverse event, expedited). No additional information was available at the time of this report.
Sex: M
Vaccine: PNC, PNC, PNC, PNC, PNC
Symptoms: Antibody test abnormal, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Complement factor normal
Clinical narrative: Information regarding PREVNAR (unspec) was received from a healthcare professional regarding a male patient who experienced otitis media. The patient completed his primary series, having received a fourth dose on 29-Oct-2003. The patient has a past history of otitis media (Nov-2004 (recovered) See related case HQWYE105409MAY07); Product was administered on 29-Oct-2003. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 29-Oct-2003, the patient received a fourth dose of PREVNAR, completing his primary series. In Apr-2005, the patient experienced otitis media. On an unspecified date, the patient recovered. See related case(s): HQWYE062008MAY07 (adverse event, expedited); HQWYE105409MAY07 (adverse event, expedited); HQWYE105609MAY07 (adverse event, expedited); HQWYE105709MAY07 (adverse event, expedited); and HQWYE105809MAY07 (adverse event, expedited). No additional information was available at the time of this report.
Sex: M
Vaccine: PNC, PNC, PNC, PNC, PNC
Symptoms: No therapeutic response, Otitis media, Platelet count increased, Therapeutic response decreased
Clinical narrative: Information regarding PREVNAR (unspec) was received from a healthcare professional regarding a male patient who experienced otitis media. The patient completed his primary series, having received a fourth dose on 29-Oct-2003. The patient has a past history of otitis media (Nov-2004 (recovered) See related case HQWYE105409MAY07); Product was administered on 29-Oct-2003. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 29-Oct-2003, the patient received a fourth dose of PREVNAR, completing his primary series. In Apr-2005, the patient experienced otitis media. On an unspecified date, the patient recovered. See related case(s): HQWYE062008MAY07 (adverse event, expedited); HQWYE105409MAY07 (adverse event, expedited); HQWYE105609MAY07 (adverse event, expedited); HQWYE105709MAY07 (adverse event, expedited); and HQWYE105809MAY07 (adverse event, expedited). No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Condition aggravated, Otitis media
Clinical narrative: Information regarding PREVNAR (unspec) was received from a healthcare professional regarding a male patient who experienced otitis media. The patient completed his primary series, having received a fourth dose on 29-Oct-2003. The patient has a past history of otitis media (Nov-2004 and Apr-2005 (recovered) See related cases HQWYE105409MAY07 and HQWYE105509MAY07). Product was administered on 29-Oct-2003. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 29-Oct-2003, the patient received a fourth dose of PREVNAR completing his primary series. In Nov-2005, the patient experienced otitis media. On an unspecified date, the patient recovered. See related case(s): HQWYE062008MAY07 (adverse event, expedited); HQWYE105409MAY07 (adverse event, non-expedited); HQWYE105509MAY07 (adverse event, expedited); HQWYE105709MAY07 (adverse event, expedited); and HQWYE105809MAY07 (adverse event, expedited). No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Injection site mass
Clinical narrative: Follow up information from the physician changed the event from redness, swelling and bump to an injection site bump. Information regarding PREVNAR was received from a healthcare professional regarding five patients who experienced a bump where shot was that lasted 2-3 months. The patients received a dose on unspecified dates. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. Five patients experienced a bump where shot was given that lasted 2-3 months (injection site mass) on unspecified dates. The outcome are unknown.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema
Clinical narrative: Information regarding PREVNAR was received from a consumer regarding a 1-year-old male patient who experienced a small red mark, size of the end of a pencil on leg after receiving vaccination. The patient received a dose in Jan-2004, a dose in Mar-2004 and a dose in May-2004. The patient experienced a small red mark, size of a pencil on leg after receiving vaccination in Jan-2004, Mar-2004, and May-2004. The reporter stated that the mark went away within a week each time. The doctor had stated that inoculation would leave a mark and the mark would disappear. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Injection site swelling
Clinical narrative: Information regarding PREVNA was received from a healthcare professional regarding a patient who experienced swelling where site of injection was done. The patient received a dose on an unspecified date. The patient experienced where site of injection was done. Outcome of the event was unknown. No additional information was available at the time of this report.
Age: 1.0
Sex: U
Vaccine: PNC
Symptoms: Body temperature increased, Diarrhoea, Pyrexia, Rash, Rotavirus test positive
Clinical narrative: Follow-up information was received that provided office phone number, date of vaccination, recovery status, illness at the time of vaccination, birth weight and laboratory test. Information regarding PREVNAR was received from a nurse regarding a 12-month-old patient who received a dose on 10-Apr-2007 and experienced fever of 103 degrees Fahrenheit, severe diarrhea, strange rash, possible hives and vomiting. Relevant medical history was not provided. Product was administered on 10-Apr-2007. Dose regimen was 1 dose 1 time per day. Concomitant medication were not reported. In Apr-2007, the patient received a dose of PREVNAR. Within 24 hours, on 10-Apr-2007, the patient experienced fever of 103 degrees Fahrenheit, severe diarrhea, strange rash that could be possible hives, and vomiting. On an unspecified date, the patient recovered from the events. Body temperature (results: 103 deg. F.) was done on 10-Apr-2007. Rotavirus test (results: positive) was done on 17-Apr-2007. See related case(s): HQWYE721920APR07 (adverse event, non-expedited). No additional information was available at the time of this report.
Age: 1.0
Sex: U
Vaccine: PNC
Symptoms: Urticaria, Vomiting
Clinical narrative: Follow-up information was received that provided office phone number, date of vaccination, recovery status, illness at the time of vaccination, birth weight and laboratory test. Information regarding PREVNAR was received from a nurse regarding a 12-month-old patient who received a dose on 10-Apr-2007 and experienced fever of 103 degrees Fahrenheit, severe diarrhea, strange rash, possible hives and vomiting. Relevant medical history was not provided. Product was administered on 10-Apr-2007. Dose regimen was 1 dose 1 time per day. Concomitant medication were not reported. In Apr-2007, the patient received a dose of PREVNAR. Within 24 hours, on 10-Apr-2007, the patient experienced fever of 103 degrees Fahrenheit, severe diarrhea, strange rash that could be possible hives, and vomiting. On an unspecified date, the patient recovered from the events. Body temperature (results: 103 deg. F.) was done on 10-Apr-2007. Rotavirus test (results: positive) was done on 17-Apr-2007. See related case(s): HQWYE721920APR07 (adverse event, non-expedited). No additional information was available at the time of this report.
Sex: U
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding an infant who received a dose on an unspecified date along with ACT-HIB and developed a red lump next to injection site. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Additional suspect medication included ACT-HIB. Concomitant medications were not reported. On an unspecified date, the patient received a dose of PREVNAR and another childhood vaccine and developed a red lump next to injection site (injection site swelling) (injection site erythema). It was unknown if the patient recovered from the event. No additional information was available at the time of this report.
Sex: U
Vaccine: IPV, PNC
Symptoms: Crying, Injection site pain
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced injection site pain. The patient received a dose on an unspecified date. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant therapy included IPOL. A Physician reported approximately 10-15 patients experienced injection site pain and cried for approximately several minutes. The physician noted this had not happened before. The patient's outcome is unknown. No additional information was available at the time of this report.
Age: 1.3
Sex: U
Vaccine: PNC
Symptoms: Irritability
Clinical narrative: Follow-up information was received that provided change in events, date of vaccination, birth weight and removal of laboratory test.  Information regarding PREVNAR was received from a nurse regarding a 15-month-old patient who received a dose on 10-Apr-2007 and experienced fussiness.  Relevant medical history was not provided.  Product was administered on 10-Apr-2007.  Dose regimen was 1 dose 1 time per day.  Concomitant medications were not reported.  On 10-Apr-2007, the patient received a dose of PREVNAR.  Within 24 hours, the patient experienced fussiness.  It was unknown if the patient recovered from the event.  See related case(s): HQWYE552113APR07 (adverse event, non-expedited).  No additional information was available at the time of this report.
Sex: F
Vaccine: PNC
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding an 18-month-old female patient who developed temperature ranging from 103 degrees to 104 degrees.  The patient received a dose on 18-Jun-2007.  The patient has a twin brother who experienced a febrile seizure with PREVNAR on the day (HQWYE727521JUN07).  Product was administered on 18-Jun-2007.  Dose regimen was 1 dose 1 time per day (intramuscular).  Concomitant medications were not reported.  On 18-Jun-2007 the patient was taken to the emergency room with a temperature ranging from 103 degrees to 104 degrees.  The patient recovered.  Body temperature (results: ranging from 103 degrees to 104 degrees) was done on 18-Jun-2007.  No additional information was available at the time of this report.
Age: 1.1
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: Information regarding PREVNAR was received from a consumer regarding a 12-month-old male patient who experienced "low grade fever, 100-100.4", very irritable and crying.  The patient received a dose on 02-Jul-2007.  Relevant medical history was not provided.  Product was administered on 02-Jul-2007.  Additional suspect medication included Varicella Virus Vaccine, Live.  Concomitant medications were not reported.  The patient's grandmother states that her grandson has been very irritable and crying since 02-Jul-2007.  She denies local site reaction and states that the patient has been running a "low grade fever, 100-100.4".  The outcome of the events is unknown.  No additional information was available at the time of this report.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RV5
Symptoms: Rash papular
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old female patient who developed a red, somewhat papular rash with fine bumps and sandpaper feel.  At 4 months of age, the patient received a dose on 26-Apr-2007.  Relevant medical history was not provided.  Product was administered on 26-Apr-2007.  Additional suspect medication included TRIPACEL, Polio Vaccine "Pasteur", ROTATEQ and RECOMBIVAX-HB.  Concomitant medications were not reported.  The patient developed a red, somewhat papular rash with fine bumps and sandpaper feel on 27-Apr-2007.  The rash was on her lower abdomen down to the left upper thigh.  No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Erythema, Induration, Pyrexia
Clinical narrative: Information regarding PREVNAR was received from a physician regarding a patient who received a dose on an unspecified date and experienced hardening under the skin, fever and redness under the skin.  Relevant medical history was not provided.  Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day.  Concomitant medications were not reported.  On an unspecified date, the patient experienced fever, hardening under the skin and redness under the skin that was "shaped like a pencil, perpendicular to the muscle fiber."  It was unknown if the patient recovered from the events.  No additional information was available at the time of this report.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 12-month-old female patient who experienced a non-tender injection site reaction of 5 cm, red and raised.  The patient received the fourth dose on 05-Nov-2007, the third dose on 08-May-2007, a dose on 07-Mar-2007 and the first dose on 05-Jan-2007.  The patient also received the first dose of Varicella Virus Vaccine, Live (manufacturer unknown) and the first dose of MMR (manufacturer unknown) on 05-Nov-2007.  The patient has a past history of no reaction on previous exposure to vaccine (no reaction following vaccination on 05-Jan-2007, or 07-Mar-2007, or 08-May-2007).  Concomitant therapy included MMR and Varicella Virus Vaccine.  The patient experienced non-tender injection site reaction of 5 cm, which was red and raised on 05-Nov-2007.  The patient was treated with oral BENADRYL.  The injection site swelling and erythema resolved on an unknown date in Nov-2007.  No additional information was available at the time of this report.
Age: 0.6
Sex: U
Vaccine: PNC
Symptoms: Injection site erythema
Clinical narrative: Information regarding PREVAR was received from a healthcare professional regarding a 6-month-old patient who experienced excessive site redness. At 6 months of age, the patient received a dose on an unspecified date. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. The patient experienced excessive site redness (injection site erythema) on 25-Nov-2007. Patient was treated with BENADRYL and an antibiotic, but has not yet recovered. No further information was provided.
Sex: U
Vaccine: PNC
Symptoms: Crying, Injection site erythema
Clinical narrative: Follow-up information included an additional event and vaccines that were administered within 4 weeks of PREVNAR administration.  Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old patient who experienced excessive site redness and excessive crying.  The patient received a dose on an unspecified date.  Relevant medical history was not provided.  Product was administered on an unspecified date.  Dose regimen was 1 dose (intramuscular).  Concomitant therapy included COMVAX, IPOL and TRIPACEL.  The patient experienced excessive site redness on 25-Nov-2007.  The patient was treated with BENADRYL.  The patient also experienced excessive crying.  The patient recovered from the injection site redness on 18-DEC-2007.  The outcome of the crying was unknown.  No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Irritability
Clinical narrative: Information regarding PREVNAR was received from a pediatrician regarding a 4-month-old patient who received a dose on an unspecified date and experienced excessive irritability.  Relevant medical history was not provided.  Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day (intramuscular).  Concomitant medications were not reported.  During 25-Nov-2007 to 18-Dec-2007, the patient developed excessive irritability.  Treatment included BENADRYL.  The patient had not recovered from the event.  No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Injection site erythema, Irritability
Clinical narrative: Information regarding PREVNAR was received from a pediatrician regarding a 2-month-old patient who received a dose in 2007 and experienced irritability and excessive injection site redness. Relevant medical history was not provided. Product was administered in 2007. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. During 25-Nov-2007 to 18-Dec-2007, the patient developed irritability and excessive injection site redness. Treatment included BENADRYL. The patient had not recovered from the event. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Irritability
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 6-month-old patient who experienced excessive irritability.  The patient received a dose on an unspecified date.  Relevant medical history was not provided.  Product was administered on an unspecified date.  Dose regimen was 1 dose.  Concomitant medications were not reported.  The patient experienced excessive irritability on 25-Nov-2007.  The patient recovered on 18-Dec-2007.  It has been determined that US-WYE-H01867307 is a duplicate report of US-WYE-H01938708.  Therefore, the reports are being consolidated into US-WYE-H01938708, which will remain the official case of record.  No additional information was available at the time of this report.
Age: 0.9
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information regarding PREVNAR was received from a pediatrician regarding a 9-month-old female patient who experienced injection site swelling and redness.  The patient received a dose on an unknown date in Dec-2007.  Relevant medical history was not provided.  Product was administered on an unknown date in Dec-2007.  Dose regimen was 0.5 mL 1 time per day (intramuscular).  Concomitant medications were not reported.  The patient experienced injection site swelling and redness on an unknown date in Dec-2007.  An ice pack was applied to the site, which eliminated the redness and swelling within one hour.  No additional information was available at the time of this report.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case has been downgraded to non-serious due to follow-up information received pertaining to event details. Additional concomitant vaccines and patient demographics were also reported. Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old female patient who experienced localized erythema and tender induration at the injection site. At 2 months of age, the patient received the first dose on an unspecified date. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant therapy included ACT-HIB and PEDIARIX. On an unknown date, the patient received her first set of vaccines. Approximately 1 hour after receiving the PREVNAR vaccine, the patient developed a localized erythema and induration, which was tender. She had no cardiopulmonary compromise and no other systemic symptoms; there was no anaphylaxis. The patient improved after receiving TYLENOL and ice application. See related case(s): US-WYE-H01951808 (adverse event, non-expedited).
Age: 0.38
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, IPV, PPV, RVX, DTAPHEPBIP, HBHEPB, IPV, PNC, RV5
Symptoms: Urticaria
Clinical narrative: FOLLOW-up information provided outcome. Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old female patient who experienced rash with urticaria like qualities.  At 4 months of age, the patient received a dose on 14-Jan-2008.  The patient also received a dose of COMVAX (Merck Sharp & Dome), a dose of DTaP (manufacturer unknown), a dose of IPOL and a dose of ROTATEQ (Merck & Co Inc) on 14-Jan-2008.  Relevant medical history was not provided.  Product was administered on 14-Jan-2008.  Additional suspect medication included COMVAX (Merck Sharp & Dome), DTaP (manufacturer unknown), ROTATEQ (Merck & Co Inc) and IPOL.  Concomitant medications were not reported.  The patient experienced rash with urticaria like qualities on 15-Jan-2008.  The rash was primarily around the facial area and arms.  Outcome was unknown.  No additional information was available at the time of this report. The patient experienced rash with urticaria like qualities on 15-Jan-2008. The rash was primarily around the facial area and arms. The patient recovered. No additional information was available at the time of this report.
Age: 0.38
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, IPV, PPV, RVX, DTAPHEPBIP, HBHEPB, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Rash, Skin test negative, Urticaria
Clinical narrative: FOLLOW-up information provided outcome. Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old female patient who experienced rash with urticaria like qualities.  At 4 months of age, the patient received a dose on 14-Jan-2008.  The patient also received a dose of COMVAX (Merck Sharp & Dome), a dose of DTaP (manufacturer unknown), a dose of IPOL and a dose of ROTATEQ (Merck & Co Inc) on 14-Jan-2008.  Relevant medical history was not provided.  Product was administered on 14-Jan-2008.  Additional suspect medication included COMVAX (Merck Sharp & Dome), DTaP (manufacturer unknown), ROTATEQ (Merck & Co Inc) and IPOL.  Concomitant medications were not reported.  The patient experienced rash with urticaria like qualities on 15-Jan-2008.  The rash was primarily around the facial area and arms.  Outcome was unknown.  No additional information was available at the time of this report. The patient experienced rash with urticaria like qualities on 15-Jan-2008. The rash was primarily around the facial area and arms. The patient recovered. No additional information was available at the time of this report.
Age: 0.38
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, IPV, PPV, RVX, DTAPHEPBIP, HBHEPB, IPV, PNC, RV5
Symptoms: Rash, Urticaria
Clinical narrative: FOLLOW-up information provided outcome. Information regarding PREVNAR was received from a healthcare professional regarding a 4-month-old female patient who experienced rash with urticaria like qualities.  At 4 months of age, the patient received a dose on 14-Jan-2008.  The patient also received a dose of COMVAX (Merck Sharp & Dome), a dose of DTaP (manufacturer unknown), a dose of IPOL and a dose of ROTATEQ (Merck & Co Inc) on 14-Jan-2008.  Relevant medical history was not provided.  Product was administered on 14-Jan-2008.  Additional suspect medication included COMVAX (Merck Sharp & Dome), DTaP (manufacturer unknown), ROTATEQ (Merck & Co Inc) and IPOL.  Concomitant medications were not reported.  The patient experienced rash with urticaria like qualities on 15-Jan-2008.  The rash was primarily around the facial area and arms.  Outcome was unknown.  No additional information was available at the time of this report. The patient experienced rash with urticaria like qualities on 15-Jan-2008. The rash was primarily around the facial area and arms. The patient recovered. No additional information was available at the time of this report.
Age: 29.0
Sex: M
Vaccine: SMALL, ANTH, HEP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt. receved Smallpox vaccine 5Apr08 in L shoulder. 13Apr08 pt. c/o fever chills, pain at injection site. Pt described the site as fist size, reddened, with black center and pt purulent drainage. Reported to MC 14Apr08 was discharged without limitations, counseling done, and follow up scheduled 16Apr08. On 16 Apr 08 pt reported symptoms decreased, no fever/ chills pain decreased, discharged without limitations follow up as needed. 24Apr08 patient c/o sharp intermittent pain in fingertips and heels, referred to MC.
Age: 29.0
Sex: M
Vaccine: SMALL, ANTH, HEP
Symptoms: Tenderness
Clinical narrative: Pt. receved Smallpox vaccine 5Apr08 in L shoulder. 13Apr08 pt. c/o fever chills, pain at injection site. Pt described the site as fist size, reddened, with black center and pt purulent drainage. Reported to MC 14Apr08 was discharged without limitations, counseling done, and follow up scheduled 16Apr08. On 16 Apr 08 pt reported symptoms decreased, no fever/ chills pain decreased, discharged without limitations follow up as needed. 24Apr08 patient c/o sharp intermittent pain in fingertips and heels, referred to MC.
Age: 29.0
Sex: M
Vaccine: SMALL, ANTH, HEP
Symptoms: Chills, Injection site discharge, Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: Pt. receved Smallpox vaccine 5Apr08 in L shoulder. 13Apr08 pt. c/o fever chills, pain at injection site. Pt described the site as fist size, reddened, with black center and pt purulent drainage. Reported to MC 14Apr08 was discharged without limitations, counseling done, and follow up scheduled 16Apr08. On 16 Apr 08 pt reported symptoms decreased, no fever/ chills pain decreased, discharged without limitations follow up as needed. 24Apr08 patient c/o sharp intermittent pain in fingertips and heels, referred to MC.
Age: 29.0
Sex: M
Vaccine: SMALL, ANTH, HEP
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Pt. receved Smallpox vaccine 5Apr08 in L shoulder. 13Apr08 pt. c/o fever chills, pain at injection site. Pt described the site as fist size, reddened, with black center and pt purulent drainage. Reported to MC 14Apr08 was discharged without limitations, counseling done, and follow up scheduled 16Apr08. On 16 Apr 08 pt reported symptoms decreased, no fever/ chills pain decreased, discharged without limitations follow up as needed. 24Apr08 patient c/o sharp intermittent pain in fingertips and heels, referred to MC.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Asthenia, Full blood count normal, Metabolic function test normal, Muscle spasms, Nervousness
Clinical narrative: Dad had shingles.  Dr. told Mom she should get the shot because she may "get" shingles from Dad!  She took the shot because she thought she was going to "catch" it from Dad.  She did have a reaction to shot.  Dr. denied that she had a reaction.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Pain, Pain, Rash macular, Thyroid function test normal
Clinical narrative: Dad had shingles.  Dr. told Mom she should get the shot because she may "get" shingles from Dad!  She took the shot because she thought she was going to "catch" it from Dad.  She did have a reaction to shot.  Dr. denied that she had a reaction.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Adverse event
Clinical narrative: Dad had shingles.  Dr. told Mom she should get the shot because she may "get" shingles from Dad!  She took the shot because she thought she was going to "catch" it from Dad.  She did have a reaction to shot.  Dr. denied that she had a reaction.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness in left arm where shot was administered.  Sensation started as a pinprick and now, the area is completely numb.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Symp. warm to touch / sharp pains and movement  of right arm. Given a ice pack in school; some Ibuprofen at home.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, IPV, MMRV
Symptoms: Pruritus, Rash, Rash papular, Scab
Clinical narrative: Exanthem with crusted papules on torso -> extrom - 1-2 dozen lesions, pruritic, increased past 2d.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Injection site rash, Screaming, Sleep disorder
Clinical narrative: Mom reported patient awoke from sleep a few hrs after vaccine. Was screaming, had pinpoint rash on left at site of 2 injections. Temp 103.7. Went to ER. Was given steroid shot. 4/22/08 - no rash or fever
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Dyspnoea, Injection site swelling, Pain in extremity, Syncope
Clinical narrative: This case was reported by a health care professional on 16 April 2008.  A 53-year-old female patient received a left upper arm intramuscular injection of Adacel (lot number C2863AA) on 04 April 2008, after sustaining a scratch to the right hand.  Medical history included an iodine allergy; she was not ill at the time of vaccination.  On 10 April 2008 the patient presented to her physician with left arm soreness and swelling at the injection site, and was treated with Keflex four times daily.  On 11 April 2008 she experienced severe chest discomfort, syncope, and shortness of breath, and was airlifted to the hospital.  The patient subsequently recovered; no additional information was provided.  The reporter considered the events to be life-threatening.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Computerised tomogram normal, Irritability
Clinical narrative: After a normal 2 mo well child exam, vaccines were given sans problems. Vaccines were given at 10:30 am. Irritability about 12-1 PM, worse by 3 PM with extreme irritability. Hospitalized and given Lorazepam x 1 with improvement for about 12 hours, then gradually returned to normal after 36 hrs. 4/30/08-records received for DOS 4/16/08-Admitted for overnight observation for C/O irritability. Excessive crying, high pitched at time and inconsolable. Right thigh slightly swollen and tender at injection site. Admitting DX: vaccine reaction present on admission. Irritability secondary to vaccine reaction.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Electrocardiogram ambulatory, Myocarditis
Clinical narrative: Vaccinated with the Smallpox "1st week in March" chest pn started 2 weeks later. Pt hospitalized hospital 22 Mar 08. Dx Myocarditis.  4/25/08 Reviewed hospital medical records for 3/29-3/31/2008. FINAL DX: none provided, no d/c summary available.  Cardiac consult states probable myocarditis secondary to smallpox vaccine. Records reveal patient experienced chest pain, EKG changes & troponin elevation at outlying ER. Patient had substernal chest pain & tightness x 4 days.    Transferred here for cardiac cath.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Catheterisation cardiac, Chest pain, Echocardiogram, Electrocardiogram ambulatory, Myocarditis
Clinical narrative: Vaccinated with the Smallpox "1st week in March" chest pn started 2 weeks later. Pt hospitalized hospital 22 Mar 08. Dx Myocarditis.  4/25/08 Reviewed hospital medical records for 3/29-3/31/2008. FINAL DX: none provided, no d/c summary available.  Cardiac consult states probable myocarditis secondary to smallpox vaccine. Records reveal patient experienced chest pain, EKG changes & troponin elevation at outlying ER. Patient had substernal chest pain & tightness x 4 days.    Transferred here for cardiac cath.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Persistent left arm pain at site of vaccination. Pain has lasted 6 months. 6/11/08-records received for DOS 10/29/07-6/2/08-on date of vaccine C/O 3 days of nasal congestion, fatigue, chills/sweats and cough. DX:pharyngitis. URI/asthma.11/7/07, 11/19/07, 11/28/07, 12/5/07,12/19/07, 1/2/08,1/16/08-Follow-up for persistent cough. Unable to work, wheezing, cough keeps her up at night, myalgia, sinusitis, new onset of type 2 diabetes mellitus. 3/12/08 first complaint of left arm pain status post pneumovax. Unable to work due to wheezing retired from job 1/16/08. 6/2/08-cough continues, unable to life arm overhead. Left shoulder pain. Follow-up: Left shoulder pain persists - unclear if this pain is related to the PNEUMOVAX. Left arm pain has resolved.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death, Pyrexia
Clinical narrative: "a bit of a fever after vaccines 8/13/2007 but cleared up and pt felt fine and ate well day before he died."  12/10/08 Death certificate states COD as SIDS.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Death
Clinical narrative: Possible SIDS 4/25/08-COD Sudden Infant Death Syndrome
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cyanosis, Death, Oxygen saturation decreased
Clinical narrative: Parents found infant blue, face down in crib around 1145 on 8/12/07. Per Coroner Possibly SIDS. CPR Attempted. Infant Pronounced Dead at 1:30 on 8/12/07. 5/27/08-records received:Cause of death-Sudden Infant Death Syndrome. Manner of death-natural
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash 1 week following vaccination.  On 4/16/08, 5-6 vesicles on trunk and face.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Most of upper outer left arm red, sore, slightly swollen.  Rx Tylenol.
Age: 4.0
Sex: F
Vaccine: DTP, IPV
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: She had swelling with blistery over shot DTP vaccine
Age: 1.1
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Erythema, Injection site mass, Injection site swelling, Skin warm
Clinical narrative: Patient had swelling, bump and warm at the touch. Patient redness was 3cm. and bump 2cm. Patient this bump and swelling on Right Leg, where MMR was given.
Age: 0.8
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Body temperature increased
Clinical narrative: Received immunizations at site at clinic.  2-3 hours later had temp 106.  Gave Tylenol & sponge bath.  Temp did not return.  Was being treated for ear infection.
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Fever; 2cm Localized erythema and edema at injection site right thigh; 3-5mm erythema at 1 site left thigh
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site erythema, Injection site induration, Skin warm
Clinical narrative: 4 cm x 5 cm area, nontender, minimally warm, mildly indurated erythema around vaccine site right thigh. Treatment: Tylenol/Ibuprofen
Age: 1.1
Sex: M
Vaccine: DTAPHEPBIP, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash began on third day after immunizations given.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: Fever within 24 hrs (102), resolved within 48 hrs.  Malaise, myalgias, improving within 48 hrs.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Expired drug administered
Clinical narrative: School sent patient with family to public health clinic to be vaccinated. Among 4 vaccines admin., DTaP was expired; received 3/3/08; expired 2/1/08; school and family notified - to re-vax in one month
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, pain which increased per patient's father over the past 2 days. Affected area was (R) thigh.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Full blood count, Pyrexia
Clinical narrative: Spoke with mother; states Imm's given at 4:00p on 9/11/07. Gave motrin prior to visit and continued to give motrin after injection q 4-6hr. Infant began running increased temp. 9/11/07 at 1030pm. Mother states today (9/13/07) Infant no longer has temp and is doing fine.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood test, Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Went to ER 2 days after receiving vaccine, with soreness, redness and swelling of (R) arm. Swelling from deltoid to elbow. Treated with antibiotics.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Dermatitis allergic, Injection site swelling
Clinical narrative: (L) arm swollen per mother (via phone call) Seen in ER: Rx Benadryl, Claritin, Tylenol, Zantac & Decadron. f/u with PMD if no improvement (PMD - Dx Allergic Dermatitis, Rx Atarax, Claritin, Gent/Decadron) arm remains swollen and bruised.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Headache, Injection site erythema, Pain in extremity
Clinical narrative: Menactra and Adacel given 4/1508. Slight T-100 on 4/16. Slight headache. 4/17/08 Redness injection site - pain with movement of arm. Redness about 10cm in diameter. No fluctuance at site
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: L upper arm swelling the evening of vaccination.  Increased swelling with redness the next morning, 10/2.  Seen in clinic 10/3 with slight decrease swelling, decrease redness, mildly tender.
Age: 36.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: pt received Adacel Tdap + MMR. On 7-25-07. Pt was advised to not get pregnant for 1 month after the vaccine.  Stated she understood, LMP 7-20-07. positive preg test 9-10-07. No problems after vaccines given.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Chest pain
Clinical narrative: Chest & back pain with breathing.
Age: 0.72
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Rash, Rash macular, Vomiting
Clinical narrative: Red little bumps all over back and stomach turned into blotches (Temp 99.8 (A) morning of 4-16). Called MD eve of 4-15 and applied Benadryl gel. 2nd time that was applied, it seemed to irritate it. Dr told then to give him liquid Benadryl. Gave it again AM of 4-16 and he vomited. Never was really fussy. AM of 4-17, rash very faded.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Brachial plexopathy
Clinical narrative: Brachial plexopathy, bilateral diagnosed as being due to Zostavax most likely by neurology consultant.  5/6/08 Reviewed PCP medical records which included neuro consult.  PCP note of 11/20 indicates patient had arthroscopic right shoulder surgery for bone spur & torn rotator cuff also noted but not repaired.  Afterward developed left arm pain for past 2 weeks which was worse when lying down, better w/sitting up.  Sleep had been difficult.  Right hip discomfort made walking difficult. Labs ordered & referred to neurology.    12/14/2007 Neuro consult for RUE shoulder & arm pain w/abrupt onset s/p vaccination into left arm & self-resolution.  Mid October developed left shoulder/arm pain w/o trauma.  Testing revealed mild weakness of right shoulder girdle, limited left shoulder ROM w/decreased left biceps reflexes. FINAL NEURO DX: strongly suspicious for bilateral sequential idiopathic/inflammatory brachial plexus neuropathies possibly assoc w/DJD or immune reaction; asymptomatic cervical spondylosis.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Convulsion
Clinical narrative: New onset seizure disorder within 24 hours. Still having seizure - MRI (borderline) and EEG (abnormal).  5/2/08 Reviewed hospital medical records of 4/3-4/5/2008.   FINAL DX: new onset seizures Records reveal patient experienced witnessed seizure while home.  Seen by PCP & had another witnessed seizure while in office w/generalized tonic-clonic activity w/postictal phase lasting approx 2 min.  Parent reported that patient had been dazed upon awakening for approx 5 days but otherwise acting normal.  Vomited night before admission.  Admitted for observation.  Peds neuro consult done & tx w/antiseizure meds.  Had a few more episodes while hospitalized. Stabilized & d/c to home w/peds neuro clinic f/u.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood thyroid stimulating hormone normal, Eyelid ptosis, Facial paresis, Full blood count normal, Hypoaesthesia oral
Clinical narrative: 24 hrs after injection c/o weakness and tingling right side of face.  Tongue numb.  Difficult to use a straw.  L eye lid with lid lag.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Metabolic function test normal, Nuclear magnetic resonance imaging brain normal, Paraesthesia
Clinical narrative: 24 hrs after injection c/o weakness and tingling right side of face.  Tongue numb.  Difficult to use a straw.  L eye lid with lid lag.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pyrexia
Clinical narrative: Student called SHS on Wed. 4/16/08 stating she had fever to 101.7 night before and her face was red for about 3 hrs around cheeks and sinuses. Appt. scheduled for 1:00 on 4/16/08. At visit no sign of facial redness.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pallor, Pyrexia
Clinical narrative: 3 days post inj -developed fever, redness, swelling to site 9x5 cm. No mottled appearance (blanches to touch)
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Back pain, Chest X-ray normal, Computerised tomogram normal
Clinical narrative: 2-3 days after Varivax he developed increasingly severe midback pain. No fever or other sx. Pain was bilateral mid thoracic. Lungs clear, CXR OK. Patient still has disabling pain, requiring analgesics.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Oedema mouth
Clinical narrative: Oral swelling and enlarged submandible lymph nodes.  Airway and swallowing not affected.
Age: 26.0
Sex: M
Vaccine: ANTH, HEP, SMALL
Symptoms: Body temperature increased, Cellulitis, Headache, Injection site erythema, Injection site pain
Clinical narrative: Patient was vaccinated on 5 April 2008.  11 April pt had severe headache, tenderness at the site; 12 April pt looked at site- "huge red spot all over my arm- was getting bigger and bigger- around the back of my arm". Pt states there was also a lot of pus at the site. Other symptoms: temp 102 degrees; stiff neck, difficulty sleeping.  Pt spoke to his family physician who told him to come to the clinic where he was vaccinated because his doctor did not have a shot record for the patient.  Pt presented to this clinic on 15 April and was sent to the Medical Center for treatment.  The immunization tech at the Clinic called and informed me that he felt that it was not an adverse rxn to vaccine but an infection due to improper care of the site and that he was not going to do a VAERS report.  Member was given antibiotics for deltoid cellulitis.
Age: 26.0
Sex: M
Vaccine: ANTH, HEP, SMALL
Symptoms: Injection site pustule, Insomnia, Musculoskeletal stiffness
Clinical narrative: Patient was vaccinated on 5 April 2008.  11 April pt had severe headache, tenderness at the site; 12 April pt looked at site- "huge red spot all over my arm- was getting bigger and bigger- around the back of my arm". Pt states there was also a lot of pus at the site. Other symptoms: temp 102 degrees; stiff neck, difficulty sleeping.  Pt spoke to his family physician who told him to come to the clinic where he was vaccinated because his doctor did not have a shot record for the patient.  Pt presented to this clinic on 15 April and was sent to the Medical Center for treatment.  The immunization tech at the Clinic called and informed me that he felt that it was not an adverse rxn to vaccine but an infection due to improper care of the site and that he was not going to do a VAERS report.  Member was given antibiotics for deltoid cellulitis.
Age: 1.4
Sex: M
Vaccine: DTAP, HBHEPB, MMR, SMALL, VARCEL
Symptoms: Allergy test, Blood heavy metal test, Malaise
Clinical narrative: Patient had gotton really sick in Dec. 2004 with 2 E.R. visits and he has been sick every since his vaccine shots. Any questions please call.
Age: 76.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: No adverse reaction. Given Tdap in lieu of Tdap. Client is 76 years old, past age of 64 years. Should have received TD. Works for health department and was getting updated TD.
Age: 27.0
Sex: M
Vaccine: MEN
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Insomnia, Nausea
Clinical narrative: At around 2000 23Apr08 I started to become nauseous with throbbing leg, back hip, and stomach pain. At around 2130 I began to burn a fever. I had the fever all night with loss of sleep.
Age: 27.0
Sex: M
Vaccine: MEN
Symptoms: Pain, Pyrexia
Clinical narrative: At around 2000 23Apr08 I started to become nauseous with throbbing leg, back hip, and stomach pain. At around 2130 I began to burn a fever. I had the fever all night with loss of sleep.