chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old female patient with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated subcutaneously with a single 0.65 ml dose of ZOSTAVAX (Lot # reported as 0255AE, expired date 14-MAR-2013) on 10-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 12-JUL-2012 the patient experienced red swelling of couple of inches around injection site and the area was hot to touch. Unspecified antibiotic was given as treatment. The patient contacted pharmacist for medical attention. At the time of this report the patient was recovering. This is one of several reports received from a same source. "Lot check requested" by the pharmacist. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old female patient with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated subcutaneously with a single 0.65 ml dose of ZOSTAVAX (Lot # reported as 0255AE, expired date 14-MAR-2013) on 10-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 12-JUL-2012 the patient experienced red swelling of couple of inches around injection site and the area was hot to touch. Unspecified antibiotic was given as treatment. The patient contacted pharmacist for medical attention. At the time of this report the patient was recovering. This is one of several reports received from a same source. "Lot check requested" by the pharmacist. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 22 years old female patient. The patient was vaccinated with dose 1 GARDASIL (Lot# and route were not reported) on 13-JAN-2009 and dose 2 (Lot# and route were not reported) in March 2009 (two months later at school) and dose 3 (Lot# and route were not reported) on 24-JUL-2012 (today). No other co-suspects were reported. No concomitant medications were reported. No adverse effect had been observed or reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Musculoskeletal stiffness, Mydriasis, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a nurse refers to a 11 year old female patient without pertinent medical history. The patient was vaccinated with the first dose of GARDASIL (0.5 ml suspension/0, 2 months, 6 months, intramuscular, lot# and expiration date were unspecified) on 06-JUL-2012 and "went stiff and her pupils dilated and was not responsive to physical or verbal stimuli". No other co-suspects were reported. Concomitant medications included MENACTRA and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) te). The patient didn't seek medical attention. The outcome of "stiff, pupils dilated and was not responsive to physical and verbal stimuli" were reported as recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. In 2010 "2 years ago" the patient was vaccinated with the first dose of GARDASIL (dose, route, lot# and expiration date were not reported). No other co-suspects were reported. No concomitant medications were reported. The patient is in the office to receive the second dose today (on 17-JUL-2012). NO adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Papule
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. A few days later the patient developed raised red papules. The patient had recovered. This is one of several reports received from the same source. Additional information is not expected.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Aphthous stomatitis, Arthralgia, Behcet's syndrome, Blood immunoglobulin G decreased, Blood immunoglobulin M decreased
Clinical narrative: This literature marketed report as received from an other health professional refers to a 48 years old female patient who had no response to pneumococcal immunization. The patient with a medical history of Behcet syndrome unresponsive to multiple immunosuppressive medications presented for further evaluation of episodic pneumonia infections occurring 3 to 4 times per year, frequent sinusitis, and recurrent skin infections. Pathergy test results were negative. The patient was diagnosed as having Behcet syndrome when she was 38 years old. Her symptoms included arthralgias, diarrhea, headache, aphthous and genital ulcers, uveitis, focal neurologic deficits, frequent cutaneous squamous cell carcinomas, and episodes of sepsis. Various immunomodulatory therapies were attempted with only minimal symptom improvement, including colchicine, hydroxychloroquine, dapsone, prednisone, rituximab, methotrexate, cyclosporine, leflunomide, cyclophosphamide, infliximab, interferon alfa, penicillin, and acyclovir. Immune evaluation was initiated, and the patient was found to have low levels of IgG (315 mg/dL) and IgM (30 mg/dL) and no response to pneumococcal immunization. Common variable immunodeficiency (CVID) was diagnosed at this time. The patient was subsequently prescribed intravenous immunoglobulin (IVIG) infusions at optimal doses (1 g/kg) every 3 weeks. Since beginning IVIG, the patient reported a decreased number of sinopulmonary and skin infections and a marked decrease in the amount of oral aphthous and genital ulcers, symptoms of uveitis, and arthralgias, At 6-month-follow-ups, IgG trough levels were well within range (1, 502 mg/dL). In this patient, the proper dose of immunoglobulin controlled the previously unresponsive inflammatory processes of Behcet syndrome and preserved remission for a period of at least 2 years. The case at hand described the first patient diagnosed as having Behcet syndrome complicated by CVID in which immunosuppressive therapies for Behcet syndrome failed but was successfully treated with ideal doses of IVIG. Although this was the second case of CVID combined with Behcet syndrome, it was the only documented case with the successful use of a therapeutic dosage of IVIG. The authors concluded that patients who possessed the dual diagnosis of Behcet syndrome and CVID might pose a treatment dilemma in that they were immunocompromised, requiring thoughtful therapeutic strategies. An optimal dose of r-globulin might provide the necessary effect to decrease symptoms in these patients. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Diarrhoea, Genital ulceration, Headache, Immunodeficiency common variable
Clinical narrative: This literature marketed report as received from an other health professional refers to a 48 years old female patient who had no response to pneumococcal immunization. The patient with a medical history of Behcet syndrome unresponsive to multiple immunosuppressive medications presented for further evaluation of episodic pneumonia infections occurring 3 to 4 times per year, frequent sinusitis, and recurrent skin infections. Pathergy test results were negative. The patient was diagnosed as having Behcet syndrome when she was 38 years old. Her symptoms included arthralgias, diarrhea, headache, aphthous and genital ulcers, uveitis, focal neurologic deficits, frequent cutaneous squamous cell carcinomas, and episodes of sepsis. Various immunomodulatory therapies were attempted with only minimal symptom improvement, including colchicine, hydroxychloroquine, dapsone, prednisone, rituximab, methotrexate, cyclosporine, leflunomide, cyclophosphamide, infliximab, interferon alfa, penicillin, and acyclovir. Immune evaluation was initiated, and the patient was found to have low levels of IgG (315 mg/dL) and IgM (30 mg/dL) and no response to pneumococcal immunization. Common variable immunodeficiency (CVID) was diagnosed at this time. The patient was subsequently prescribed intravenous immunoglobulin (IVIG) infusions at optimal doses (1 g/kg) every 3 weeks. Since beginning IVIG, the patient reported a decreased number of sinopulmonary and skin infections and a marked decrease in the amount of oral aphthous and genital ulcers, symptoms of uveitis, and arthralgias, At 6-month-follow-ups, IgG trough levels were well within range (1, 502 mg/dL). In this patient, the proper dose of immunoglobulin controlled the previously unresponsive inflammatory processes of Behcet syndrome and preserved remission for a period of at least 2 years. The case at hand described the first patient diagnosed as having Behcet syndrome complicated by CVID in which immunosuppressive therapies for Behcet syndrome failed but was successfully treated with ideal doses of IVIG. Although this was the second case of CVID combined with Behcet syndrome, it was the only documented case with the successful use of a therapeutic dosage of IVIG. The authors concluded that patients who possessed the dual diagnosis of Behcet syndrome and CVID might pose a treatment dilemma in that they were immunocompromised, requiring thoughtful therapeutic strategies. An optimal dose of r-globulin might provide the necessary effect to decrease symptoms in these patients. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Immunoglobulin therapy, Immunology test abnormal, Nervous system disorder, No therapeutic response, Pneumonia
Clinical narrative: This literature marketed report as received from an other health professional refers to a 48 years old female patient who had no response to pneumococcal immunization. The patient with a medical history of Behcet syndrome unresponsive to multiple immunosuppressive medications presented for further evaluation of episodic pneumonia infections occurring 3 to 4 times per year, frequent sinusitis, and recurrent skin infections. Pathergy test results were negative. The patient was diagnosed as having Behcet syndrome when she was 38 years old. Her symptoms included arthralgias, diarrhea, headache, aphthous and genital ulcers, uveitis, focal neurologic deficits, frequent cutaneous squamous cell carcinomas, and episodes of sepsis. Various immunomodulatory therapies were attempted with only minimal symptom improvement, including colchicine, hydroxychloroquine, dapsone, prednisone, rituximab, methotrexate, cyclosporine, leflunomide, cyclophosphamide, infliximab, interferon alfa, penicillin, and acyclovir. Immune evaluation was initiated, and the patient was found to have low levels of IgG (315 mg/dL) and IgM (30 mg/dL) and no response to pneumococcal immunization. Common variable immunodeficiency (CVID) was diagnosed at this time. The patient was subsequently prescribed intravenous immunoglobulin (IVIG) infusions at optimal doses (1 g/kg) every 3 weeks. Since beginning IVIG, the patient reported a decreased number of sinopulmonary and skin infections and a marked decrease in the amount of oral aphthous and genital ulcers, symptoms of uveitis, and arthralgias, At 6-month-follow-ups, IgG trough levels were well within range (1, 502 mg/dL). In this patient, the proper dose of immunoglobulin controlled the previously unresponsive inflammatory processes of Behcet syndrome and preserved remission for a period of at least 2 years. The case at hand described the first patient diagnosed as having Behcet syndrome complicated by CVID in which immunosuppressive therapies for Behcet syndrome failed but was successfully treated with ideal doses of IVIG. Although this was the second case of CVID combined with Behcet syndrome, it was the only documented case with the successful use of a therapeutic dosage of IVIG. The authors concluded that patients who possessed the dual diagnosis of Behcet syndrome and CVID might pose a treatment dilemma in that they were immunocompromised, requiring thoughtful therapeutic strategies. An optimal dose of r-globulin might provide the necessary effect to decrease symptoms in these patients. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Sepsis, Sinusitis, Skin infection, Squamous cell carcinoma of skin, Uveitis
Clinical narrative: This literature marketed report as received from an other health professional refers to a 48 years old female patient who had no response to pneumococcal immunization. The patient with a medical history of Behcet syndrome unresponsive to multiple immunosuppressive medications presented for further evaluation of episodic pneumonia infections occurring 3 to 4 times per year, frequent sinusitis, and recurrent skin infections. Pathergy test results were negative. The patient was diagnosed as having Behcet syndrome when she was 38 years old. Her symptoms included arthralgias, diarrhea, headache, aphthous and genital ulcers, uveitis, focal neurologic deficits, frequent cutaneous squamous cell carcinomas, and episodes of sepsis. Various immunomodulatory therapies were attempted with only minimal symptom improvement, including colchicine, hydroxychloroquine, dapsone, prednisone, rituximab, methotrexate, cyclosporine, leflunomide, cyclophosphamide, infliximab, interferon alfa, penicillin, and acyclovir. Immune evaluation was initiated, and the patient was found to have low levels of IgG (315 mg/dL) and IgM (30 mg/dL) and no response to pneumococcal immunization. Common variable immunodeficiency (CVID) was diagnosed at this time. The patient was subsequently prescribed intravenous immunoglobulin (IVIG) infusions at optimal doses (1 g/kg) every 3 weeks. Since beginning IVIG, the patient reported a decreased number of sinopulmonary and skin infections and a marked decrease in the amount of oral aphthous and genital ulcers, symptoms of uveitis, and arthralgias, At 6-month-follow-ups, IgG trough levels were well within range (1, 502 mg/dL). In this patient, the proper dose of immunoglobulin controlled the previously unresponsive inflammatory processes of Behcet syndrome and preserved remission for a period of at least 2 years. The case at hand described the first patient diagnosed as having Behcet syndrome complicated by CVID in which immunosuppressive therapies for Behcet syndrome failed but was successfully treated with ideal doses of IVIG. Although this was the second case of CVID combined with Behcet syndrome, it was the only documented case with the successful use of a therapeutic dosage of IVIG. The authors concluded that patients who possessed the dual diagnosis of Behcet syndrome and CVID might pose a treatment dilemma in that they were immunocompromised, requiring thoughtful therapeutic strategies. An optimal dose of r-globulin might provide the necessary effect to decrease symptoms in these patients. Additional information has been requested.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 8 months old patient. The patient was vaccinated with VAQTA (lot# is unknown) on 13-JUL-2012. No adverse effect was reported, it's unknown if the patient sought medical attention. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative, Vaccination failure
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 months old female patient. The patient was vaccinated with first and second dose of MMR II (lot number not reported) on 05-JUN-1992 and 04-AUG-1995. No other co-suspects were reported. No concomitant medications were reported. The patient had negative mumps titer and required a booster dose. At the time of the report, the patient status was unknown. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to a 5 years old male patient. The patient was vaccinated with a dose of expired MMR II (lot # 667246/0907Z, exp. date 09-JUL-2012) on 16-JUL-2012. If the patient sought medical attention or not was unknown. No adverse reactions reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning a female patient of unknown age who was vaccinated with a 0.5ml dose 1 of GARDASIL, IM (Lot # not reported) on 24-MAY-2011 and with 0.5 ml dose 2 of GARDASIL, IM (Lot # not reported) on 12-JUL-2012, over a year after. No other co-suspects were reported. No concomitant medications were reported. NO adverse effects were reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacist concerning a male patient of unknown age with no allergies and no pertinent history who was vaccinated with  0.65 ml dose of ZOSTAVAX (Batch # 0364AE, Expiry date 16-MAR-2013) (lot # not reported), SQ on 14-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that the patient brought a prescription of BACTRIM and prednisone 5mg 6 day dose pack for treatment of an unspecified condition to the pharmacy on 19-JUL-2012. At the time of reporting the patient had not recovered. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a consumer concerning her female neighbor of unknown age who on an unspecified date was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer stated that a couple of days later (no dates provided) she broke out in a rash in the center of her chest. The consumer described that she did not see it; she was just informed what happened after receiving the vaccine. No treatment information was reported. The outcome of rash in the center of the chest was unknown. The relatedness for ash in the center of the chest was unknown for ZOSTAVAX. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 years old female patient without drug allergies and medical history. The patient did not develop any immunity after having 3 dose series of some unspecified hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route, lot# and expiration date were unspecified). The therapy started on 27-NOV-1992. The lab diagnostics studies blood titer has been performed. The patient sought medical attention via coming into office for a titer. No other co-suspects were reported. No concomitant medications were reported. The outcome of did not develop any immunity after have 3 doses series is unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to a 68 years old female patient with allergy to codeine and no medical history. The patient was received 0.65 ZOSTAVAX (lot # 0240AE, expires 15-MAR-2013) on 18-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse said that the patient reported that her arm was red and swollen at the injection site, when she woke up on 19-JUL-2012. Nurse reported that the patient was seen in the office on 19-JUL-2012, and that an area measuring one by one-and-a-half inches surrounding the injection site appeared red, warm and swollen. Nurse reported that the patient was treated with cortisone cream at the time of the office visit. Nurse reported that the patient returned to the practice on 20-JUL-2012, that the area of redness, warmth and swelling had grown to 2 inches, and that the patient was then administered and 80 mg DEPOMEDROL injection. There was no laboratory studies performed. At the time of the report, the outcomes of adverse events were reported as recovering/resolving. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic
Clinical narrative: This spontaneous report as received from a 76 years old female patient with heart murmur, depression and arthritis refers to herself. The patient's medical history included 3 feet of her colon removed and gallbladder removed. The patient had no drug allergies. The patient was vaccinated with ZOSTAVAX (Lot#unspecified) in November-2009. Concomitant medications included: "Cholesterol medication Heart medication, anti-depression, NEURONTIN" and PREVACID. On 12-JUL-2012 the patient had a zoster breakout on her left eye. The patient was treated with NEURONTIN. The outcome was unknown. The patient had sought unspecified medical attention. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a 56 year old female with no pertinent medical history and no drug reactions/allergies who on 11-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (672604/1656AA, exp. 21-JAN-2013), S.Q., (dose not reported). The pharmacist reported that "on 12-JUN-2012 the patient developed a rash. The rash started at the site of injection and extended a few inches down the arm. There was no itch or pain. The rash had a shingles-like appearance." The patient sought medical attention by calling the pharmacy. No treatment was given. No lab diagnostics was performed. At the time of reporting, the patient had not recovered. The follow up information has been received from a registry nurse refers to the same patient with allergic to Penicillin and sulfa. She stated that the patient was not seen at her facility for either vaccine or reaction. The patient was vaccinated at pharmacy. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning multiple unspecified patients that might have received doses of GARDASIL (doses, routes and lot # not reported) at longer intervals than those recommended. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 of GARDASIL (route, dose, lot# and expiration were not reported) on 18-JUN-2010 and today, on 17-JUL-2012, the patient was in the office to receive the second dose and no adverse effects reported. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Sudden death
Clinical narrative: Case number PHHY2012US064481 is an initial literature report received on 26 Jul 2012. The health authority and Center for Disease Control (CDC) searched in Vaccine Adverse Event Reporting System (VAERS) to determine the safety of H1N1 from 01 Oct 2009 to 24 Nov 2009. This case refers to a 01-year-old male child. Medical history included of febrile seizures once after MMR vaccination (other manufacturer and batch number: not reported) on an unspecified date. The child was vaccinated with H1N1 (manufacturer and batch number: unknown, hence conservatively taken as pandemic influenza vaccine INN) on an unspecified date between 01 Oct 2009 to 24 Nov 2009. One day post vaccination the child died suddenly without any evidence of trauma. No other information pertaining to this patient was available. It was stated that the deaths reported in this literature reflect a range of underlying conditions, some of which cannot be reasonably attributed to vaccination (however, it was not reported which of the death cases are ruled as a complication of underlying illness). The author also stated that it is difficult to establish a confident link between the deaths and vaccination since the time period was very less (only 2 months). The author also stated that this data could detect safety signals (new unexpected or rare events) but generally cannot be used to infer causality. It was concluded that the CDC review of reports from the Vaccine Adverse Event Reporting System showed no concerning safety signals (i.e., new, unexpected, or rare adverse events), and analysis of data from the Vaccine Safety Data Link found no increased occurrence of monitored conditions after H1N1 vaccination.
Age: 2.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Cardio-respiratory arrest, Death
Clinical narrative: Case number PHHY2012US064535 is an initial literature report received on 26 Jul 2012. The health authority and Center for Disease Control (CDC) searched in Vaccine Adverse Event Reporting System (VAERS) to determine the safety of H1N1 from 01 Oct 2009 to 24 Nov 2009. This case refers to a 02-year-old female child. Medical history included of encephalopathy, central apnea, traumatic brain damage, seizures. The child was vaccinated with H1N1 (manufacturer and batch number: unknown, hence conservatively taken as pandemic influenza vaccine INN) on an unspecified date between 01 Oct 2009 to 24 Nov 2009. On the same day of vaccination the child died due to sudden cardiopulmonary arrest. No other information pertaining to this patient was available. It was stated that the deaths reported in this literature reflect a range of underlying conditions, some of which cannot be reasonably attributed to vaccination (however, it was not reported which of the death cases are ruled as a complication of underlying illness). The author also stated that it is difficult to establish a confident link between the deaths and vaccination since the time period was very less (only 2 months). The author also stated that this data could detect safety signals (new unexpected or rare events) but generally cannot be used to infer causality. It was concluded that the CDC review of reports from the Vaccine Adverse Event Reporting System showed no concerning safety signals (i.e., new, unexpected, or rare adverse events), and analysis of data from the Vaccine Safety Data Link found no increased occurrence of monitored conditions after H1N1 vaccination.
Age: 56.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Death, Road traffic accident
Clinical narrative: Case number PHHY2012US064569 is an initial literature report received on 26 Jul 2012: The health authority and Center for Disease Control (CDC) searched in Vaccine Adverse Event Reporting System (VAERS) to determine the safety of H1N1 from 01 Oct 2009 to 24 Nov 2009. This report refers to a 56-year-old female patient. Her medical history was not reported. She was vaccinated with H1N1 (manufacturer and batch number: unknown, hence conservatively taken as pandemic influenza vaccine INN) on an unspecified date between 01 Oct 2009 to 24 Nov 2009. On the same day after vaccination she met with a motor vehicle crash and experienced trauma. It was reported that she was the driver involved in motor vehicle crash and she died due to these event. No other information pertaining to this patient was available. It was concluded that the deaths reported reflected a range of underlying conditions, some of which could not be attributed to vaccination (however, it was not reported which of the death cases are ruled as a complication of underlying illness). It was also stated that is was difficult to establish a confident link between the deaths and vaccination since the time period was very less (only 2 months). This data could detect safety signals (new unexpected or rare events) but generally could not be used to infer causality. CDC review of reports from the Vaccine Adverse Event Reporting System showed no concerning safety signals (i.e., new, unexpected, or rare adverse events), and analysis of data from the Vaccine Safety Data Link found no increased occurrence of monitored conditions after H1N1 vaccination.
Age: 56.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Death, Injury, Road traffic accident
Clinical narrative: Case number PHHY2012US064569 is an initial literature report received on 26 Jul 2012: The health authority and Center for Disease Control (CDC) searched in Vaccine Adverse Event Reporting System (VAERS) to determine the safety of H1N1 from 01 Oct 2009 to 24 Nov 2009. This report refers to a 56-year-old female patient. Her medical history was not reported. She was vaccinated with H1N1 (manufacturer and batch number: unknown, hence conservatively taken as pandemic influenza vaccine INN) on an unspecified date between 01 Oct 2009 to 24 Nov 2009. On the same day after vaccination she met with a motor vehicle crash and experienced trauma. It was reported that she was the driver involved in motor vehicle crash and she died due to these event. No other information pertaining to this patient was available. It was concluded that the deaths reported reflected a range of underlying conditions, some of which could not be attributed to vaccination (however, it was not reported which of the death cases are ruled as a complication of underlying illness). It was also stated that is was difficult to establish a confident link between the deaths and vaccination since the time period was very less (only 2 months). This data could detect safety signals (new unexpected or rare events) but generally could not be used to infer causality. CDC review of reports from the Vaccine Adverse Event Reporting System showed no concerning safety signals (i.e., new, unexpected, or rare adverse events), and analysis of data from the Vaccine Safety Data Link found no increased occurrence of monitored conditions after H1N1 vaccination.
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Trunkal rash, no petechiae.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Crying, Dyskinesia, Full blood count, Gaze palsy, Hypoaesthesia
Clinical narrative: Pt. very nervous - on exam table in mom's arms. CBC done by finger stick, MENACTRA administered IM to (L) deltoid. Pt. became very pale/ashy. Pt. then became unconscious in mom's arms. Eyes rolled to back of head, pt. then had seizure-like episode. Entire body jerking and shaking. Lasted approx 5-8 seconds. Pt. was groggy and crying when came to. Also lethargic, c/o nausea and numbness to (L) side of body. B/P - 115/80. Gave popsicle and crackers. Let pt. rest - took approx 45 minutes for pt. to recover/get up. Sent home with mom.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Lethargy, Loss of consciousness, Nausea, Nervousness, Pallor
Clinical narrative: Pt. very nervous - on exam table in mom's arms. CBC done by finger stick, MENACTRA administered IM to (L) deltoid. Pt. became very pale/ashy. Pt. then became unconscious in mom's arms. Eyes rolled to back of head, pt. then had seizure-like episode. Entire body jerking and shaking. Lasted approx 5-8 seconds. Pt. was groggy and crying when came to. Also lethargic, c/o nausea and numbness to (L) side of body. B/P - 115/80. Gave popsicle and crackers. Let pt. rest - took approx 45 minutes for pt. to recover/get up. Sent home with mom.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Seizure like phenomena, Somnolence, Tremor
Clinical narrative: Pt. very nervous - on exam table in mom's arms. CBC done by finger stick, MENACTRA administered IM to (L) deltoid. Pt. became very pale/ashy. Pt. then became unconscious in mom's arms. Eyes rolled to back of head, pt. then had seizure-like episode. Entire body jerking and shaking. Lasted approx 5-8 seconds. Pt. was groggy and crying when came to. Also lethargic, c/o nausea and numbness to (L) side of body. B/P - 115/80. Gave popsicle and crackers. Let pt. rest - took approx 45 minutes for pt. to recover/get up. Sent home with mom.
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient was vaccinated with a 0.5 ml of GARDASIL (lot number, therapy route and site not reported) "this morning" on 24-JUL-2012 and then passed out. No other co-suspects or concomitant medications were reported. It was not known if this was the patient's first dose or not, so no therapy start date was available. The patient visited doctor's office for medical attention. The outcome was unknown. Upon internal review, passed out was  considered to be a medically significant event. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Dermatitis allergic, Injection site reaction, Rash papular
Clinical narrative: Erythematous papular rash (B) thigh (site of injections) within 24 hours of administration -> looks allergic. Not infections treatment as allergic dermatitis.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Hyperhidrosis, Vision blurred
Clinical narrative: Patient, c/o blurred vision, dizziness & sweating after MENACTRA admin.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an eight-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 3 doses of PENTACEL; received on 30 November 2011, 25 January 2012 and 28 March 2012 (lot numbers, routes and sites of administration not reported). On 11 June 2012, the subject developed a cough, seventy five days after the last dose. The subject developed a paroxysmal cough with whoop on 21 June 2012. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 25 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 25 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 26 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in an eight-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 3 doses of PENTACEL; received on 30 November 2011, 25 January 2012 and 28 March 2012 (lot numbers, routes and sites of administration not reported). On 11 June 2012, the subject developed a cough, seventy five days after the last dose. The subject developed a paroxysmal cough with whoop on 21 June 2012. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 25 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 25 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 26 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.26
Sex: M
Vaccine: DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the the post-marketing study under the reference number M5A16. A case of pertussis disease in a 15-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; received on 19 May 2011, 19 July 2011 and 19 September 2011 (lot numbers not reported) and one dose of DAPTACEL; lot number C4035AA received on 19 June 2012 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 20 June 2012, approximately one day after the last dose. On 26 June 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 27 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.26
Sex: M
Vaccine: DTAP
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the the post-marketing study under the reference number M5A16. A case of pertussis disease in a 15-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; received on 19 May 2011, 19 July 2011 and 19 September 2011 (lot numbers not reported) and one dose of DAPTACEL; lot number C4035AA received on 19 June 2012 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 20 June 2012, approximately one day after the last dose. On 26 June 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 27 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.88
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Culture negative, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a three-year-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 3 doses of PENTACEL; lot number C3289AB received on 05 August 2009, lot number C3545AA received on 12 February 2010 and lot number C3606AA received on 02 June 2010 and one dose of DAPTACEL; lot number C3618AA received on 13 April 2011 (routes and sites of administration not reported). On 13 June 2012, the subject developed a cough and paroxysmal cough without a whoop, approximately 14 months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR and negative culture on 28 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 02 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 19 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.88
Sex: F
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a three-year-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 3 doses of PENTACEL; lot number C3289AB received on 05 August 2009, lot number C3545AA received on 12 February 2010 and lot number C3606AA received on 02 June 2010 and one dose of DAPTACEL; lot number C3618AA received on 13 April 2011 (routes and sites of administration not reported). On 13 June 2012, the subject developed a cough and paroxysmal cough without a whoop, approximately 14 months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR and negative culture on 28 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 02 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 19 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Pt had swelling & temp at injection site approximately 3 in in diameter 3 days after injection. Spoke to MA & Rec. use Diphenhydramine 25 mg PO q8h PRN. Spoke to Pt 7/25/12 and she says redness, itchiness & swelling have gone way done. No other adverse events reported by pt.
Age: 1.59
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Cough, Dyspnoea, Heart rate increased, Labyrinthitis, Oxygen saturation decreased
Clinical narrative: MMR, Varicella, INFANRIX Dtap administered on 07/03/12 child had shortness of breath, and cough was seen in ER 07/06/12, Dx reaction to MMR.
Age: 1.59
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pneumonia, Vaccination complication
Clinical narrative: MMR, Varicella, INFANRIX Dtap administered on 07/03/12 child had shortness of breath, and cough was seen in ER 07/06/12, Dx reaction to MMR.
Age: 1.3
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) database. The subject had received 4 doses of PENTACEL on the following dates: 18 September 2009, 20 November 2009, 29 January 2010 and 03 November 2010 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms on 28 May 2012, approximately one year and seven months after the last dose. On 04 June 2012, the subject developed a paroxysmal cough with a whoop. Laboratory testing included positive PCR on 08 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 25 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.3
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction
Clinical narrative: Initial report received on 18 July 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) database. The subject had received 4 doses of PENTACEL on the following dates: 18 September 2009, 20 November 2009, 29 January 2010 and 03 November 2010 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms on 28 May 2012, approximately one year and seven months after the last dose. On 04 June 2012, the subject developed a paroxysmal cough with a whoop. Laboratory testing included positive PCR on 08 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 25 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Musculoskeletal pain
Clinical narrative: Pt. developed pain, redness; lacy looking rash to right upper arm. Slightly swollen, c/o pain from (R) neck & shoulder radiating to (R) upper arm. Evaluated by Dr. - ? reaction vs shingles. Treated with KEFLEX & VALTREX.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain
Clinical narrative: Pt. developed pain, redness; lacy looking rash to right upper arm. Slightly swollen, c/o pain from (R) neck & shoulder radiating to (R) upper arm. Evaluated by Dr. - ? reaction vs shingles. Treated with KEFLEX & VALTREX.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.