chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Anaphylactic reaction, Dyspnoea, Lip swelling, Pruritus, Swollen tongue
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 year old female patient with a history of allergic rhinitis, wheezing and no known allergies, was vaccinated on 16-JAN-2012 with the second dose of GARDASIL, (lot # 671006/1291AA), I.M, in the left arm. The patient received GARDASIL #2. 3 hours later, the patient started to have difficulty breathing, rash; lip and tongue edema. The patient was seen at emergency room (ER) for anaphylaxis. Submucosal Injection Polypectomy (SIP) epinephrine, methylprednisolone, and diphenhydramine. The patient was discharged (D/C) home on oral prednisone and EPIPEN. The following information was obtained through follow-up and/or provided by the government. 20-JAN-2012. ER records date of service (DOS) 16-JAN-2012. Diagnosis (DX): anaphylaxis. Chief complaint (CC): difficulty breathing; skin rash with pruritus; tongue swelling; sensation of lump in throat; voice changes. Physical examination (PE): anxious; swollen lips/tongue; urticarial rash. X rays were taken (Rxed), epinephrine; steroid and antihistamine were administered. Patient's condition improved. Released in stable condition to f/u primary care physician (PCP). This report was considered serious and immediately life threatening. It required emergency room / doctor visit. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # 447576. A priority lot check investigation has been finalized. All in-process quality checks for the lot number 671006/1291AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 23.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Maternal exposure during pregnancy, Stillbirth
Clinical narrative: Case number PHHY2012US038099 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 447638) on 07 May 2012 with a follow up received from the quality assurance department (ref. number: 159999) on 15 May 2012, with a follow up batch review report received from quality assurance department (ref. number: 159999) on 23 May 2012. This case refers to a 23-year-old female patient. Her medical history was not reported. She was vaccinated with FLUVIRIN (batch number: 1100801) intramuscularly into her right arm on 04 Oct 2011. She was pregnant at the time of vaccination and she was receiving prenatal vitamins concomitantly. On 16 Oct 2011 she had a still born child at 31 weeks. No other information was available. The quality assurance department opened a complaint with reference number 159999. The batch review report was as follows: batch review report received from quality assurance department (ref. number: 159999) was as follows: based on the document review, it was stated that the concerned FLUVIRIN (1100801) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up received from the quality assurance department on 15 May 2012: QA reference number updated. Follow up batch review report received from quality assurance department (ref. number: 159999) on 23 May 2012: Updated batch review report.
Age: 41.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Pain in extremity, Pyrexia, Skin warm, White blood cell count increased
Clinical narrative: Case number PHHY2012US038470 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 450718) on 07 May 2012, with a follow up batch review report received from quality assurance department (ref. number: 160430) on 25 May 2012. This case refers to a 41-year-old male patient. His medical history included of chronic obstructive pulmonary disease. His concurrent illness included of severe pain and cellulitis of nose. This poly medicated patient was vaccinated with FLUVIRIN (batch number: 11062P) intramuscularly into his left arm on 27 Feb 2012. On the same day he was also vaccinated with PNEUMOVAX (other manufacturer, batch number: 1418AA) intramuscularly into his left arm. His post injection temperature was normal. On 28 Feb 2012, his left arm became red, warm to touch and was painful to light touch. On an unspecified date, he was admitted with fever and elevated white blood cells. The outcome of these events was reported as condition unchanged. The batch review report was as follows: batch review report received from quality assurance department (ref. number: 160430) was as follows: based on the document review, it was stated that the concerned FLUVIRIN (11062P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up batch review report received from quality assurance department (ref. number: 160430) on 23 May 2012: Updated batch review report.
Age: 41.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Pyrexia, Skin warm, Tenderness, White blood cell count increased
Clinical narrative: Case number PHHY2012US038470 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 450718) on 07 May 2012, with a follow up batch review report received from quality assurance department (ref. number: 160430) on 25 May 2012. This case refers to a 41-year-old male patient. His medical history included of chronic obstructive pulmonary disease. His concurrent illness included of severe pain and cellulitis of nose. This poly medicated patient was vaccinated with FLUVIRIN (batch number: 11062P) intramuscularly into his left arm on 27 Feb 2012. On the same day he was also vaccinated with PNEUMOVAX (other manufacturer, batch number: 1418AA) intramuscularly into his left arm. His post injection temperature was normal. On 28 Feb 2012, his left arm became red, warm to touch and was painful to light touch. On an unspecified date, he was admitted with fever and elevated white blood cells. The outcome of these events was reported as condition unchanged. The batch review report was as follows: batch review report received from quality assurance department (ref. number: 160430) was as follows: based on the document review, it was stated that the concerned FLUVIRIN (11062P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up batch review report received from quality assurance department (ref. number: 160430) on 23 May 2012: Updated batch review report.
Age: 0.4
Sex: M
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Biopsy skin abnormal, Blister, Blood creatinine, Dermatitis bullous, Histamine normal
Clinical narrative: It was reported in a published article that a life-threatening episodes of mast cell activation can occur in diffuse cutaneous mastocytosis (DCM), a rare form of pediatric mastocytosis with reported incidence of 1-8%. Bullous eruptions in DCM have been reported after trauma, infections and medication administration. The article present a child with generalized bullous eruption after routine vaccination. A 5 month-old child received scheduled vaccination with Hemophilus influenzae B., PCV, poliomyelitis (inactivated), rotavirus vaccine and DT. Total and mature tryptase levels and skin pathology were evaluated. The patient was diagnosed with DCM at 3 months based on the peau d'orange appearance of his skin with positive Darier sign. Total tryptase was 64 with mature fraction of 3.1, urinary histamine 873 creatinine. Skin biopsy revealed a patchy band-like infiltrate of mononuclear cells in the dermis positive for tryptase and CD117. Therapy with H1 and H2-antagonists and topical sodium cromoglycate was initiated. A day after his routine vaccination at 5 months, he developed systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fever and generalized malaise. A 5-day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. Vaccinations are an under-recognized trigger for blistering in children with DCM. Premedication and vaccine administration on "one-at-a-time" basis may reduce the severity. Systemic steroids improve outcomes. Bullous eruptions was considered to be life-threatening by the authors. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Malaise, Nausea, Pyrexia, Tryptase increased, Vomiting
Clinical narrative: It was reported in a published article that a life-threatening episodes of mast cell activation can occur in diffuse cutaneous mastocytosis (DCM), a rare form of pediatric mastocytosis with reported incidence of 1-8%. Bullous eruptions in DCM have been reported after trauma, infections and medication administration. The article present a child with generalized bullous eruption after routine vaccination. A 5 month-old child received scheduled vaccination with Hemophilus influenzae B., PCV, poliomyelitis (inactivated), rotavirus vaccine and DT. Total and mature tryptase levels and skin pathology were evaluated. The patient was diagnosed with DCM at 3 months based on the peau d'orange appearance of his skin with positive Darier sign. Total tryptase was 64 with mature fraction of 3.1, urinary histamine 873 creatinine. Skin biopsy revealed a patchy band-like infiltrate of mononuclear cells in the dermis positive for tryptase and CD117. Therapy with H1 and H2-antagonists and topical sodium cromoglycate was initiated. A day after his routine vaccination at 5 months, he developed systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fever and generalized malaise. A 5-day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. Vaccinations are an under-recognized trigger for blistering in children with DCM. Premedication and vaccine administration on "one-at-a-time" basis may reduce the severity. Systemic steroids improve outcomes. Bullous eruptions was considered to be life-threatening by the authors. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Biopsy skin abnormal, Blister, Blood creatinine, Dermatitis bullous, Histamine level
Clinical narrative: It was reported in a published article that a life-threatening episodes of mast cell activation can occur in diffuse cutaneous mastocytosis (DCM), a rare form of pediatric mastocytosis with reported incidence of 1-8%. Bullous eruptions in DCM have been reported after trauma, infections and medication administration. The article present a child with generalized bullous eruption after routine vaccination. A 5 month-old child received scheduled vaccination with Hemophilus influenzae B., PCV, poliomyelitis (inactivated), rotavirus vaccine and DT. Total and mature tryptase levels and skin pathology were evaluated. The patient was diagnosed with DCM at 3 months based on the peau d'orange appearance of his skin with positive Darier sign. Total tryptase was 64 with mature fraction of 3.1, urinary histamine 873 creatinine. Skin biopsy revealed a patchy band-like infiltrate of mononuclear cells in the dermis positive for tryptase and CD117. Therapy with H1 and H2-antagonists and topical sodium cromoglycate was initiated. A day after his routine vaccination at 5 months, he developed systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fever and generalized malaise. A 5-day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. Vaccinations are an under-recognized trigger for blistering in children with DCM. Premedication and vaccine administration on "one-at-a-time" basis may reduce the severity. Systemic steroids improve outcomes. Bullous eruptions was considered to be life-threatening by the authors. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Keratosis follicular, Malaise, Nausea, Pathology test, Peau d'orange
Clinical narrative: It was reported in a published article that a life-threatening episodes of mast cell activation can occur in diffuse cutaneous mastocytosis (DCM), a rare form of pediatric mastocytosis with reported incidence of 1-8%. Bullous eruptions in DCM have been reported after trauma, infections and medication administration. The article present a child with generalized bullous eruption after routine vaccination. A 5 month-old child received scheduled vaccination with Hemophilus influenzae B., PCV, poliomyelitis (inactivated), rotavirus vaccine and DT. Total and mature tryptase levels and skin pathology were evaluated. The patient was diagnosed with DCM at 3 months based on the peau d'orange appearance of his skin with positive Darier sign. Total tryptase was 64 with mature fraction of 3.1, urinary histamine 873 creatinine. Skin biopsy revealed a patchy band-like infiltrate of mononuclear cells in the dermis positive for tryptase and CD117. Therapy with H1 and H2-antagonists and topical sodium cromoglycate was initiated. A day after his routine vaccination at 5 months, he developed systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fever and generalized malaise. A 5-day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. Vaccinations are an under-recognized trigger for blistering in children with DCM. Premedication and vaccine administration on "one-at-a-time" basis may reduce the severity. Systemic steroids improve outcomes. Bullous eruptions was considered to be life-threatening by the authors. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Pyrexia, Tryptase increased, Vomiting
Clinical narrative: It was reported in a published article that a life-threatening episodes of mast cell activation can occur in diffuse cutaneous mastocytosis (DCM), a rare form of pediatric mastocytosis with reported incidence of 1-8%. Bullous eruptions in DCM have been reported after trauma, infections and medication administration. The article present a child with generalized bullous eruption after routine vaccination. A 5 month-old child received scheduled vaccination with Hemophilus influenzae B., PCV, poliomyelitis (inactivated), rotavirus vaccine and DT. Total and mature tryptase levels and skin pathology were evaluated. The patient was diagnosed with DCM at 3 months based on the peau d'orange appearance of his skin with positive Darier sign. Total tryptase was 64 with mature fraction of 3.1, urinary histamine 873 creatinine. Skin biopsy revealed a patchy band-like infiltrate of mononuclear cells in the dermis positive for tryptase and CD117. Therapy with H1 and H2-antagonists and topical sodium cromoglycate was initiated. A day after his routine vaccination at 5 months, he developed systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fever and generalized malaise. A 5-day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. Vaccinations are an under-recognized trigger for blistering in children with DCM. Premedication and vaccine administration on "one-at-a-time" basis may reduce the severity. Systemic steroids improve outcomes. Bullous eruptions was considered to be life-threatening by the authors. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Blister, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: It was reported in a published article that a life-threatening episodes of mast cell activation can occur in diffuse cutaneous mastocytosis (DCM), a rare form of pediatric mastocytosis with reported incidence of 1-8%. Bullous eruptions in DCM have been reported after trauma, infections and medication administration. The article present a child with generalized bullous eruption after routine vaccination. A 5 month-old child received scheduled vaccination with Hemophilus influenzae B., PCV, poliomyelitis (inactivated), rotavirus vaccine and DT. Total and mature tryptase levels and skin pathology were evaluated. The patient was diagnosed with DCM at 3 months based on the peau d'orange appearance of his skin with positive Darier sign. Total tryptase was 64 with mature fraction of 3.1, urinary histamine 873 creatinine. Skin biopsy revealed a patchy band-like infiltrate of mononuclear cells in the dermis positive for tryptase and CD117. Therapy with H1 and H2-antagonists and topical sodium cromoglycate was initiated. A day after his routine vaccination at 5 months, he developed systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fever and generalized malaise. A 5-day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. Vaccinations are an under-recognized trigger for blistering in children with DCM. Premedication and vaccine administration on "one-at-a-time" basis may reduce the severity. Systemic steroids improve outcomes. Bullous eruptions was considered to be life-threatening by the authors. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Biopsy skin abnormal, Blister, Blood creatinine, Dermatitis bullous, Histamine normal
Clinical narrative: Initial case was retrieved from the scientific literature on 16 May 2012. A 5-month-old male patient with a history of diffuse cutaneous mastocytosis (DCM) had received scheduled vaccination with Hib, PCV, IPV, rotavirus vaccine and diphtheria and tetanus Toxoid (manufacturers, lot numbers, routes, sites and dates of administration not reported) and a day after vaccination, the patient developed systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fevers and generalized malaise. A five day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. The patient had been diagnosed with DCM at 3 months of age based on the "peau d'orange" appearance of his skin with positive Darier sign. Therapy with H1 and H2-antagonists and topical sodium cromoglycate was initiated at that time. Authors stated that vaccinations are an under recognized trigger for blistering in children with DCM. Premedication and "one-at-a-time" vaccine administration may reduce the severity. No further information was available at the time of the report. Documents held by sender: none.
Age: 0.4
Sex: M
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Malaise, Nausea, Pyrexia, Tryptase increased, Vomiting
Clinical narrative: Initial case was retrieved from the scientific literature on 16 May 2012. A 5-month-old male patient with a history of diffuse cutaneous mastocytosis (DCM) had received scheduled vaccination with Hib, PCV, IPV, rotavirus vaccine and diphtheria and tetanus Toxoid (manufacturers, lot numbers, routes, sites and dates of administration not reported) and a day after vaccination, the patient developed systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fevers and generalized malaise. A five day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. The patient had been diagnosed with DCM at 3 months of age based on the "peau d'orange" appearance of his skin with positive Darier sign. Therapy with H1 and H2-antagonists and topical sodium cromoglycate was initiated at that time. Authors stated that vaccinations are an under recognized trigger for blistering in children with DCM. Premedication and "one-at-a-time" vaccine administration may reduce the severity. No further information was available at the time of the report. Documents held by sender: none.
Age: 0.4
Sex: M
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Biopsy skin abnormal, Blister, Blood creatinine, Dermatitis bullous, Histamine level
Clinical narrative: Initial case was retrieved from the scientific literature on 16 May 2012. A 5-month-old male patient with a history of diffuse cutaneous mastocytosis (DCM) had received scheduled vaccination with Hib, PCV, IPV, rotavirus vaccine and diphtheria and tetanus Toxoid (manufacturers, lot numbers, routes, sites and dates of administration not reported) and a day after vaccination, the patient developed systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fevers and generalized malaise. A five day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. The patient had been diagnosed with DCM at 3 months of age based on the "peau d'orange" appearance of his skin with positive Darier sign. Therapy with H1 and H2-antagonists and topical sodium cromoglycate was initiated at that time. Authors stated that vaccinations are an under recognized trigger for blistering in children with DCM. Premedication and "one-at-a-time" vaccine administration may reduce the severity. No further information was available at the time of the report. Documents held by sender: none.
Age: 0.4
Sex: M
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Keratosis follicular, Malaise, Nausea, Pathology test, Peau d'orange
Clinical narrative: Initial case was retrieved from the scientific literature on 16 May 2012. A 5-month-old male patient with a history of diffuse cutaneous mastocytosis (DCM) had received scheduled vaccination with Hib, PCV, IPV, rotavirus vaccine and diphtheria and tetanus Toxoid (manufacturers, lot numbers, routes, sites and dates of administration not reported) and a day after vaccination, the patient developed systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fevers and generalized malaise. A five day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. The patient had been diagnosed with DCM at 3 months of age based on the "peau d'orange" appearance of his skin with positive Darier sign. Therapy with H1 and H2-antagonists and topical sodium cromoglycate was initiated at that time. Authors stated that vaccinations are an under recognized trigger for blistering in children with DCM. Premedication and "one-at-a-time" vaccine administration may reduce the severity. No further information was available at the time of the report. Documents held by sender: none.
Age: 0.4
Sex: M
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Pyrexia, Tryptase increased, Vomiting
Clinical narrative: Initial case was retrieved from the scientific literature on 16 May 2012. A 5-month-old male patient with a history of diffuse cutaneous mastocytosis (DCM) had received scheduled vaccination with Hib, PCV, IPV, rotavirus vaccine and diphtheria and tetanus Toxoid (manufacturers, lot numbers, routes, sites and dates of administration not reported) and a day after vaccination, the patient developed systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fevers and generalized malaise. A five day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. The patient had been diagnosed with DCM at 3 months of age based on the "peau d'orange" appearance of his skin with positive Darier sign. Therapy with H1 and H2-antagonists and topical sodium cromoglycate was initiated at that time. Authors stated that vaccinations are an under recognized trigger for blistering in children with DCM. Premedication and "one-at-a-time" vaccine administration may reduce the severity. No further information was available at the time of the report. Documents held by sender: none.
Age: 0.4
Sex: M
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Blister, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: Initial case was retrieved from the scientific literature on 16 May 2012. A 5-month-old male patient with a history of diffuse cutaneous mastocytosis (DCM) had received scheduled vaccination with Hib, PCV, IPV, rotavirus vaccine and diphtheria and tetanus Toxoid (manufacturers, lot numbers, routes, sites and dates of administration not reported) and a day after vaccination, the patient developed systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fevers and generalized malaise. A five day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. The patient had been diagnosed with DCM at 3 months of age based on the "peau d'orange" appearance of his skin with positive Darier sign. Therapy with H1 and H2-antagonists and topical sodium cromoglycate was initiated at that time. Authors stated that vaccinations are an under recognized trigger for blistering in children with DCM. Premedication and "one-at-a-time" vaccine administration may reduce the severity. No further information was available at the time of the report. Documents held by sender: none.
Age: 46.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Patient admitted for pancreatitis on 5/18/2012, received pneumococcal vaccine 5/21/2012 6:57PM in left arm, then developed LUE cellulitis. He was started empirically on Ancef but erythema continued to progress down his left arm, so was switched to Vancomycin 5/24 and rec'd Vancomycin for 2 days. Cellulitis responded well to Vancomycin with near resolution, then switched to doxycycline 5/26. On 5/27 the cellulitis was nearly completely resolved with some residual pain in left arm but really no erythema or significant induration.
Age: 46.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site cellulitis, Pain in extremity
Clinical narrative: Patient admitted for pancreatitis on 5/18/2012, received pneumococcal vaccine 5/21/2012 6:57PM in left arm, then developed LUE cellulitis. He was started empirically on Ancef but erythema continued to progress down his left arm, so was switched to Vancomycin 5/24 and rec'd Vancomycin for 2 days. Cellulitis responded well to Vancomycin with near resolution, then switched to doxycycline 5/26. On 5/27 the cellulitis was nearly completely resolved with some residual pain in left arm but really no erythema or significant induration.
Age: 1.04
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever and vomiting. Treatment with TYLENOL.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis (Rt) upper arm - discharge summary included. Vaccine administered at pharmacy.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Immediate post-injection reaction, Joint range of motion decreased, Pain, Radiculitis brachial
Clinical narrative: Client reports "brachial neuritis". Onset of pain was immediate, has had pain, weakness, limited ROM since.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Blood glucose increased, Dizziness, Headache, Nausea
Clinical narrative: Pt stated 3 hours after shot felt dizzy, nauseous, had H/A, tested blood sugar & was almost 400 which is never that high, took double dose of Glipizide 10 mg & B/S remained high throughout day close to 200) & again at 24 hours later.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient developed rash at her right side of body and saw doctor on 5/15/12 and her doctor confirmed she had shingles and prescribed Acyclovir 800 mg and she's now recovered.
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on approximately 23-MAR-2012 ("2 months ago") was vaccinated SQ with a single dose of ZOSTAVAX (Merck) (lot # not reported) at the pharmacy. On approximately 23-MAR-2012 ("2 months ago") the patient developed redness and swelling at the site of injection. The patient had difficulty raising the affected arm which caused her to miss 2 days of work as a hospital nurse. The patient contacted her unspecified physician and was prescribed an unspecified medication. Subsequently, the patient fully recovered from the events on an unspecified date. Having difficulty raising the affected arm was considered to be disabling by the reporter. No further information is available.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Approx 24hrs later on 5/1812 patient c/o red, very itchy, hot to touch and hard from mid (R) arm thru shoulder and reported on 5/21/12 reported that slowly got better and is now still itchy and pink as of 5/20/12 evening.
Sex: F
Vaccine: HPV4
Symptoms: Breech presentation, Foetal disorder, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a 28 year old female consumer reporting on her son, concerning male baby patient whose mother (previously reported in WAES# 1107USA00135) with no pertinent medical history and no drug reactions or allergies who in "first week" of April 2011, was vaccinated with GARDASIL, a Pregnancy Registry product (lot number, dose and route not
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Complication of delivery, Maternal exposure before pregnancy, Pregnancy test
Clinical narrative: Information has been received from a 28 year old female consumer for GARDASIL, a Pregnancy Registry product, reporting on herself with no pertinent medical history and no drug reactions or allergies who "first week" in April 2011, was vaccinated with a dose of GARDASIL (lot number, dose and route not reported) and found out that she was currently 7 weeks pregnant. At the "end of may" a pregnancy test, blood work was
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Ectopic pregnancy, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse for GARDASIL a pregnancy Registry product, concerning a 17 year old female patient who on 16-MAY-2011, was vaccinated with the first dose of GARDASIL (route and lot number not reported) while pregnant. The patient's last menstrual period was on 11-APR-2011 and estimated delivery date would be 16-JAN-2012. No symptoms reported. The patient sought medical
Sex: M
Vaccine: HPV4
Symptoms: Convulsion, Gaze palsy
Clinical narrative: Information has been received from a medical assistant concerning 5 male patients who on unknown dates were vaccinated with a dose of GARDASIL (dose, route and lot # not provided). The medical assistant in the physician's office reported that on unknown dates, all 5 patients experienced convulsions and eyes rolling up in their head (results not provided). On an unspecified date, the physician ordered a head exam for one patient. On unknown dates, the patients recovered from the events. The patients sought unspecified medical attention. Upon internal review experienced convulsions was considered to be an other medical event. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 1.28
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Polymerase chain reaction, Post-tussive vomiting
Clinical narrative: Initial report received on 18 May 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 21-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3670AA received on 02 August 2010, lot number C3565AB received on 05 October 2010; lot number C3565AB received on 03 December 2010 and lot number C3980AA received on 13 September 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 24 March 2012, approximately 6 months after the last dose. On 26 March 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 30 March 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 30 March 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 18 April 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.28
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Sleep disorder
Clinical narrative: Initial report received on 18 May 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 21-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3670AA received on 02 August 2010, lot number C3565AB received on 05 October 2010; lot number C3565AB received on 03 December 2010 and lot number C3980AA received on 13 September 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 24 March 2012, approximately 6 months after the last dose. On 26 March 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 30 March 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 30 March 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 18 April 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 18 May 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in an 11-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3754AA received on 30 June 2011, lot number C3867AA received on 19 September 2011 and lot number C3892BA received on 18 November 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 11 April 2012, approximately 4 months after the last dose. On 18 April 2012, the subject developed a cough and then a paroxysmal cough with whoop started on 22 April 2012. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 28 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 April 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 26 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 18 May 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in an 11-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3754AA received on 30 June 2011, lot number C3867AA received on 19 September 2011 and lot number C3892BA received on 18 November 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 11 April 2012, approximately 4 months after the last dose. On 18 April 2012, the subject developed a cough and then a paroxysmal cough with whoop started on 22 April 2012. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 28 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 April 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 26 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Polymerase chain reaction
Clinical narrative: Initial report received on 18 May 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3436AA received on 05 January 2010, lot number not reported received on 08 March 2010, lot number not reported received on 10 May 2010 and 1 dose of DAPTACEL; lot number C3191AA received on 07 February 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 18 April 2012, approximately 14 months after the last dose. On 21 April 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 27 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 April 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 02 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Company Medical Assessment: No vaccine protects 100% of individuals against infection. Because this case was solicited from an electronic database, medical records are not available so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. This is one case out of a cumulative total of 67 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 18 May 2012. These 67 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Sleep disorder
Clinical narrative: Initial report received on 18 May 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3436AA received on 05 January 2010, lot number not reported received on 08 March 2010, lot number not reported received on 10 May 2010 and 1 dose of DAPTACEL; lot number C3191AA received on 07 February 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 18 April 2012, approximately 14 months after the last dose. On 21 April 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 27 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 April 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 02 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Company Medical Assessment: No vaccine protects 100% of individuals against infection. Because this case was solicited from an electronic database, medical records are not available so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. This is one case out of a cumulative total of 67 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 18 May 2012. These 67 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 18 May 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a nine-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C4026AA received on 22 September 2011, lot number C3999AA received on 23 November 2011 and lot number C4047AA received on 08 February 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 15 April 2012 approximately 2 months after the last dose. On 26 April 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttusstive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR  on 29 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 29 April 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 30 days. Investigator causality assessment is not required as per protocol. Company Medical Assessment: No vaccine protects 100% of individuals against infection and it is not unexpected to find cases of pertussis after only 3 doses of PENTACEL. Because this case was solicited from an electronic database, medical records are not available so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. This is one case out of a cumulative total of 67 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 18 May 2012. These 67 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccine from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 18 May 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a nine-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C4026AA received on 22 September 2011, lot number C3999AA received on 23 November 2011 and lot number C4047AA received on 08 February 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 15 April 2012 approximately 2 months after the last dose. On 26 April 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttusstive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR  on 29 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 29 April 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 30 days. Investigator causality assessment is not required as per protocol. Company Medical Assessment: No vaccine protects 100% of individuals against infection and it is not unexpected to find cases of pertussis after only 3 doses of PENTACEL. Because this case was solicited from an electronic database, medical records are not available so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. This is one case out of a cumulative total of 67 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 18 May 2012. These 67 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccine from other manufacturers are not reported as per study protocol. Documents held by sender: None.