chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Walking aid user
Clinical narrative: This spontaneous report as received from a 70 years old male patient refers to himself with high blood pressure. The patient had no drug reactions/allergies. On 01-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # unspecified) dose, route and location unspecified and an influenza virus vaccine (unspecified) (Lot # U8908AA, expiry date: 30-JUN-2014, Sanofi Pharmaceuticals) at the same time, and had developed "numbness" in both of his feet after receiving these two vaccines. The patient reported that the numbness in his feet happened "immediately" after receiving the two vaccines, "at the same time on the same exact day". The patient stated "certain days my feet feel like I am walking with broken bones and the numbness is always there." The patient then reported that the numbness would go into the "ankle" area and half way up into his knees. The reporter stated the he felt like was "walking on nails". The reporter also stated that he had experienced the numbness in his hands. The patient then stated that within the last 4 or 5 days (estimated in January 2014), the bottoms of his feet are "red hot". The patient also stated he was using many other"unspecified medications" (names/dosage/frequencies/manufacturers unspecified). The patient stated that he was not recovered and now he was using a "cane" to help him walk. The patient had sought medical attention via saw the doctor. Upon internal review, these events were considered as disability. Follow up information was received from a registered nurse which reported that was administered the ZOSTAVAX at the local pharmacy (unknown). On 31-OCT-2013 the patient was last seen in physician's office for significant numbness and tingling in his feet. He was referred to a Neurologist and was seen on 29-OCT-2013. Outcome of tingling in his feet was unknown. Causality was not reported. Concomitant therapies included DIOVAN, NEURONTIN, allopurinol, metoprolol, clonidine, DETROL, hydralazine (Dosage and frequency unspecified). Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Blood test, Electromyogram, Hypoaesthesia, Infusion, Neuropathy peripheral
Clinical narrative: This spontaneous report as received from a 70 years old male patient refers to himself with high blood pressure. The patient had no drug reactions/allergies. On 01-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # unspecified) dose, route and location unspecified and an influenza virus vaccine (unspecified) (Lot # U8908AA, expiry date: 30-JUN-2014, Sanofi Pharmaceuticals) at the same time, and had developed "numbness" in both of his feet after receiving these two vaccines. The patient reported that the numbness in his feet happened "immediately" after receiving the two vaccines, "at the same time on the same exact day". The patient stated "certain days my feet feel like I am walking with broken bones and the numbness is always there." The patient then reported that the numbness would go into the "ankle" area and half way up into his knees. The reporter stated the he felt like was "walking on nails". The reporter also stated that he had experienced the numbness in his hands. The patient then stated that within the last 4 or 5 days (estimated in January 2014), the bottoms of his feet are "red hot". The patient also stated he was using many other"unspecified medications" (names/dosage/frequencies/manufacturers unspecified). The patient stated that he was not recovered and now he was using a "cane" to help him walk. The patient had sought medical attention via saw the doctor. Upon internal review, these events were considered as disability. Follow up information was received from a registered nurse which reported that was administered the ZOSTAVAX at the local pharmacy (unknown). On 31-OCT-2013 the patient was last seen in physician's office for significant numbness and tingling in his feet. He was referred to a Neurologist and was seen on 29-OCT-2013. Outcome of tingling in his feet was unknown. Causality was not reported. Concomitant therapies included DIOVAN, NEURONTIN, allopurinol, metoprolol, clonidine, DETROL, hydralazine (Dosage and frequency unspecified). Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Walking aid user
Clinical narrative: This spontaneous report as received from a 70 years old male patient refers to himself with high blood pressure. The patient had no drug reactions/allergies. On 01-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # unspecified) dose, route and location unspecified and an influenza virus vaccine (unspecified) (Lot # U8908AA, expiry date: 30-JUN-2014, Sanofi Pharmaceuticals) at the same time, and had developed "numbness" in both of his feet after receiving these two vaccines. The patient reported that the numbness in his feet happened "immediately" after receiving the two vaccines, "at the same time on the same exact day". The patient stated "certain days my feet feel like I am walking with broken bones and the numbness is always there." The patient then reported that the numbness would go into the "ankle" area and half way up into his knees. The reporter stated the he felt like was "walking on nails". The reporter also stated that he had experienced the numbness in his hands. The patient then stated that within the last 4 or 5 days (estimated in January 2014), the bottoms of his feet are "red hot". The patient also stated he was using many other"unspecified medications" (names/dosage/frequencies/manufacturers unspecified). The patient stated that he was not recovered and now he was using a "cane" to help him walk. The patient had sought medical attention via saw the doctor. Upon internal review, these events were considered as disability. Follow up information was received from a registered nurse which reported that was administered the ZOSTAVAX at the local pharmacy (unknown). On 31-OCT-2013 the patient was last seen in physician's office for significant numbness and tingling in his feet. He was referred to a Neurologist and was seen on 29-OCT-2013. Outcome of tingling in his feet was unknown. Causality was not reported. Concomitant therapies included DIOVAN, NEURONTIN, allopurinol, metoprolol, clonidine, DETROL, hydralazine (Dosage and frequency unspecified). Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Erythema, Hypoaesthesia, Immediate post-injection reaction, Paraesthesia, Skin warm
Clinical narrative: This spontaneous report as received from a 70 years old male patient refers to himself with high blood pressure. The patient had no drug reactions/allergies. On 01-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # unspecified) dose, route and location unspecified and an influenza virus vaccine (unspecified) (Lot # U8908AA, expiry date: 30-JUN-2014, Sanofi Pharmaceuticals) at the same time, and had developed "numbness" in both of his feet after receiving these two vaccines. The patient reported that the numbness in his feet happened "immediately" after receiving the two vaccines, "at the same time on the same exact day". The patient stated "certain days my feet feel like I am walking with broken bones and the numbness is always there." The patient then reported that the numbness would go into the "ankle" area and half way up into his knees. The reporter stated the he felt like was "walking on nails". The reporter also stated that he had experienced the numbness in his hands. The patient then stated that within the last 4 or 5 days (estimated in January 2014), the bottoms of his feet are "red hot". The patient also stated he was using many other"unspecified medications" (names/dosage/frequencies/manufacturers unspecified). The patient stated that he was not recovered and now he was using a "cane" to help him walk. The patient had sought medical attention via saw the doctor. Upon internal review, these events were considered as disability. Follow up information was received from a registered nurse which reported that was administered the ZOSTAVAX at the local pharmacy (unknown). On 31-OCT-2013 the patient was last seen in physician's office for significant numbness and tingling in his feet. He was referred to a Neurologist and was seen on 29-OCT-2013. Outcome of tingling in his feet was unknown. Causality was not reported. Concomitant therapies included DIOVAN, NEURONTIN, allopurinol, metoprolol, clonidine, DETROL, hydralazine (Dosage and frequency unspecified). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Anaphylactic reaction, Blood immunoglobulin E increased, Skin test, Skin test positive
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 4-year-old male subject who as vaccinated with Influenza vaccine (unspecified), manufacturer unspecified). The subject's medical history included food reaction; he avoided unbaked egg secondary to a history of perioral rash with ingestion of meringue icing. After the event his mother reported that he had developed watery mouth, abdominal pain and weakness with the ingestion of gummy candies, gummy vitamins and marshmallows in the past. Historic vaccination included influenza virus vaccine; manufacturer unspecified; given on an unspecified date which went uncomplicated. No further information on his medical, family history or concurrent medication is available. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, injection site and batch number). Within 15 minutes after vaccination with Influenza vaccine (unspecified), the subject experienced gelatine allergy (significant gelatine IgE-sensitization), diffuse hives, watery eyes, sneezing and vomiting. The diagnosis was anaphylactic reaction. This case was assessed as medically serious by GSK. A treatment with Epinephrine provided as an emergency action plan and reviewed the management of food allergies were recommended as the avoidance of all foods containing unbaked egg and gelatin. The subject's family opted to defer additional immunization with gelatin-containing vaccines. After the event the subject was referred for evaluation of his allergies. Skin prick testing showed a wheal of 4 mm and a flare of 21 mm with commercial egg extract; and a wheal of 13 mm and a flare of 33 mm with fresh gelatine. Serum testing showed an IgE level of 4.76 kIU/L for egg white and 0.39 kIU/L for bovine gelatine. He was offered follow up skin prick testing with fish-derived gelatine to determine if he could tolerate non-mamalian gelatine but the family declined further testing. At the time of reporting the outcome of the events was unspecified. Author's conclusion: "Gelatin is a mixture of peptides and proteins produced by partial hydrolysis of collagen extracted from cow, pig, and fish. It is found in various foods, beverages, medications, plasma expanders, and vaccines. Gelatin allergy should be considered in any patient with a history of reaction to gelatin-containing foods or pharmaceutical products. Management of gelatin allergy includes provision of thorough avoidance measures, prescription of epinephrine, and periodic re-evaluation to determine if oral food challenges should be considered with decreasing IgE levels and skin prick testing."
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Anaphylactic reaction, Blood immunoglobulin E decreased, Food allergy, Lacrimation increased, Skin test positive
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 4-year-old male subject who as vaccinated with Influenza vaccine (unspecified), manufacturer unspecified). The subject's medical history included food reaction; he avoided unbaked egg secondary to a history of perioral rash with ingestion of meringue icing. After the event his mother reported that he had developed watery mouth, abdominal pain and weakness with the ingestion of gummy candies, gummy vitamins and marshmallows in the past. Historic vaccination included influenza virus vaccine; manufacturer unspecified; given on an unspecified date which went uncomplicated. No further information on his medical, family history or concurrent medication is available. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, injection site and batch number). Within 15 minutes after vaccination with Influenza vaccine (unspecified), the subject experienced gelatine allergy (significant gelatine IgE-sensitization), diffuse hives, watery eyes, sneezing and vomiting. The diagnosis was anaphylactic reaction. This case was assessed as medically serious by GSK. A treatment with Epinephrine provided as an emergency action plan and reviewed the management of food allergies were recommended as the avoidance of all foods containing unbaked egg and gelatin. The subject's family opted to defer additional immunization with gelatin-containing vaccines. After the event the subject was referred for evaluation of his allergies. Skin prick testing showed a wheal of 4 mm and a flare of 21 mm with commercial egg extract; and a wheal of 13 mm and a flare of 33 mm with fresh gelatine. Serum testing showed an IgE level of 4.76 kIU/L for egg white and 0.39 kIU/L for bovine gelatine. He was offered follow up skin prick testing with fish-derived gelatine to determine if he could tolerate non-mamalian gelatine but the family declined further testing. At the time of reporting the outcome of the events was unspecified. Author's conclusion: "Gelatin is a mixture of peptides and proteins produced by partial hydrolysis of collagen extracted from cow, pig, and fish. It is found in various foods, beverages, medications, plasma expanders, and vaccines. Gelatin allergy should be considered in any patient with a history of reaction to gelatin-containing foods or pharmaceutical products. Management of gelatin allergy includes provision of thorough avoidance measures, prescription of epinephrine, and periodic re-evaluation to determine if oral food challenges should be considered with decreasing IgE levels and skin prick testing."
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Sneezing, Urticaria, Vomiting
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 4-year-old male subject who as vaccinated with Influenza vaccine (unspecified), manufacturer unspecified). The subject's medical history included food reaction; he avoided unbaked egg secondary to a history of perioral rash with ingestion of meringue icing. After the event his mother reported that he had developed watery mouth, abdominal pain and weakness with the ingestion of gummy candies, gummy vitamins and marshmallows in the past. Historic vaccination included influenza virus vaccine; manufacturer unspecified; given on an unspecified date which went uncomplicated. No further information on his medical, family history or concurrent medication is available. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, injection site and batch number). Within 15 minutes after vaccination with Influenza vaccine (unspecified), the subject experienced gelatine allergy (significant gelatine IgE-sensitization), diffuse hives, watery eyes, sneezing and vomiting. The diagnosis was anaphylactic reaction. This case was assessed as medically serious by GSK. A treatment with Epinephrine provided as an emergency action plan and reviewed the management of food allergies were recommended as the avoidance of all foods containing unbaked egg and gelatin. The subject's family opted to defer additional immunization with gelatin-containing vaccines. After the event the subject was referred for evaluation of his allergies. Skin prick testing showed a wheal of 4 mm and a flare of 21 mm with commercial egg extract; and a wheal of 13 mm and a flare of 33 mm with fresh gelatine. Serum testing showed an IgE level of 4.76 kIU/L for egg white and 0.39 kIU/L for bovine gelatine. He was offered follow up skin prick testing with fish-derived gelatine to determine if he could tolerate non-mamalian gelatine but the family declined further testing. At the time of reporting the outcome of the events was unspecified. Author's conclusion: "Gelatin is a mixture of peptides and proteins produced by partial hydrolysis of collagen extracted from cow, pig, and fish. It is found in various foods, beverages, medications, plasma expanders, and vaccines. Gelatin allergy should be considered in any patient with a history of reaction to gelatin-containing foods or pharmaceutical products. Management of gelatin allergy includes provision of thorough avoidance measures, prescription of epinephrine, and periodic re-evaluation to determine if oral food challenges should be considered with decreasing IgE levels and skin prick testing."
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Anaphylactic reaction, Lacrimation increased, Serology test, Skin test, Skin test positive
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 4-year-old male subject who as vaccinated with Influenza vaccine (unspecified), manufacturer unspecified). The subject's medical history included food reaction; he avoided unbaked egg secondary to a history of perioral rash with ingestion of meringue icing. After the event his mother reported that he had developed watery mouth, abdominal pain and weakness with the ingestion of gummy candies, gummy vitamins and marshmallows in the past. Historic vaccination included influenza virus vaccine; manufacturer unspecified; given on an unspecified date which went uncomplicated. No further information on his medical, family history or concurrent medication is available. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, injection site and batch number). Within 15 minutes after vaccination with Influenza vaccine (unspecified), the subject experienced gelatine allergy (significant gelatine IgE-sensitization), diffuse hives, watery eyes, sneezing and vomiting. The diagnosis was anaphylactic reaction. This case was assessed as medically serious by GSK. A treatment with Epinephrine provided as an emergency action plan and reviewed the management of food allergies were recommended as the avoidance of all foods containing unbaked egg and gelatin. The subject's family opted to defer additional immunization with gelatin-containing vaccines. After the event the subject was referred for evaluation of his allergies. Skin prick testing showed a wheal of 4 mm and a flare of 21 mm with commercial egg extract; and a wheal of 13 mm and a flare of 33 mm with fresh gelatine. Serum testing showed an IgE level of 4.76 kIU/L for egg white and 0.39 kIU/L for bovine gelatine. He was offered follow up skin prick testing with fish-derived gelatine to determine if he could tolerate non-mamalian gelatine but the family declined further testing. At the time of reporting the outcome of the events was unspecified. Author's conclusion: "Gelatin is a mixture of peptides and proteins produced by partial hydrolysis of collagen extracted from cow, pig, and fish. It is found in various foods, beverages, medications, plasma expanders, and vaccines. Gelatin allergy should be considered in any patient with a history of reaction to gelatin-containing foods or pharmaceutical products. Management of gelatin allergy includes provision of thorough avoidance measures, prescription of epinephrine, and periodic re-evaluation to determine if oral food challenges should be considered with decreasing IgE levels and skin prick testing."
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Anaphylactic reaction, Food allergy, Lacrimation increased, Sneezing, Urticaria
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 4-year-old male subject who as vaccinated with Influenza vaccine (unspecified), manufacturer unspecified). The subject's medical history included food reaction; he avoided unbaked egg secondary to a history of perioral rash with ingestion of meringue icing. After the event his mother reported that he had developed watery mouth, abdominal pain and weakness with the ingestion of gummy candies, gummy vitamins and marshmallows in the past. Historic vaccination included influenza virus vaccine; manufacturer unspecified; given on an unspecified date which went uncomplicated. No further information on his medical, family history or concurrent medication is available. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, injection site and batch number). Within 15 minutes after vaccination with Influenza vaccine (unspecified), the subject experienced gelatine allergy (significant gelatine IgE-sensitization), diffuse hives, watery eyes, sneezing and vomiting. The diagnosis was anaphylactic reaction. This case was assessed as medically serious by GSK. A treatment with Epinephrine provided as an emergency action plan and reviewed the management of food allergies were recommended as the avoidance of all foods containing unbaked egg and gelatin. The subject's family opted to defer additional immunization with gelatin-containing vaccines. After the event the subject was referred for evaluation of his allergies. Skin prick testing showed a wheal of 4 mm and a flare of 21 mm with commercial egg extract; and a wheal of 13 mm and a flare of 33 mm with fresh gelatine. Serum testing showed an IgE level of 4.76 kIU/L for egg white and 0.39 kIU/L for bovine gelatine. He was offered follow up skin prick testing with fish-derived gelatine to determine if he could tolerate non-mamalian gelatine but the family declined further testing. At the time of reporting the outcome of the events was unspecified. Author's conclusion: "Gelatin is a mixture of peptides and proteins produced by partial hydrolysis of collagen extracted from cow, pig, and fish. It is found in various foods, beverages, medications, plasma expanders, and vaccines. Gelatin allergy should be considered in any patient with a history of reaction to gelatin-containing foods or pharmaceutical products. Management of gelatin allergy includes provision of thorough avoidance measures, prescription of epinephrine, and periodic re-evaluation to determine if oral food challenges should be considered with decreasing IgE levels and skin prick testing."
Age: 4.0
Sex: M
Vaccine: FLU3, FLUX, FLUX, FLUX
Symptoms: Vomiting
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 4-year-old male subject who as vaccinated with Influenza vaccine (unspecified), manufacturer unspecified). The subject's medical history included food reaction; he avoided unbaked egg secondary to a history of perioral rash with ingestion of meringue icing. After the event his mother reported that he had developed watery mouth, abdominal pain and weakness with the ingestion of gummy candies, gummy vitamins and marshmallows in the past. Historic vaccination included influenza virus vaccine; manufacturer unspecified; given on an unspecified date which went uncomplicated. No further information on his medical, family history or concurrent medication is available. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, injection site and batch number). Within 15 minutes after vaccination with Influenza vaccine (unspecified), the subject experienced gelatine allergy (significant gelatine IgE-sensitization), diffuse hives, watery eyes, sneezing and vomiting. The diagnosis was anaphylactic reaction. This case was assessed as medically serious by GSK. A treatment with Epinephrine provided as an emergency action plan and reviewed the management of food allergies were recommended as the avoidance of all foods containing unbaked egg and gelatin. The subject's family opted to defer additional immunization with gelatin-containing vaccines. After the event the subject was referred for evaluation of his allergies. Skin prick testing showed a wheal of 4 mm and a flare of 21 mm with commercial egg extract; and a wheal of 13 mm and a flare of 33 mm with fresh gelatine. Serum testing showed an IgE level of 4.76 kIU/L for egg white and 0.39 kIU/L for bovine gelatine. He was offered follow up skin prick testing with fish-derived gelatine to determine if he could tolerate non-mamalian gelatine but the family declined further testing. At the time of reporting the outcome of the events was unspecified. Author's conclusion: "Gelatin is a mixture of peptides and proteins produced by partial hydrolysis of collagen extracted from cow, pig, and fish. It is found in various foods, beverages, medications, plasma expanders, and vaccines. Gelatin allergy should be considered in any patient with a history of reaction to gelatin-containing foods or pharmaceutical products. Management of gelatin allergy includes provision of thorough avoidance measures, prescription of epinephrine, and periodic re-evaluation to determine if oral food challenges should be considered with decreasing IgE levels and skin prick testing."
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Itching on back left shoulder, injection side on left arm that night. next night more itching and noticed hive on breast. Also had tiny red bumps on back, neck, and legs as well as injection site. injection site red and lifted. Also swelling of throat but not enough to interfere with breathing. Just swallowing. Have not felt the need to go to the hospital yet.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Rash, Rash erythematous, Urticaria
Clinical narrative: Itching on back left shoulder, injection side on left arm that night. next night more itching and noticed hive on breast. Also had tiny red bumps on back, neck, and legs as well as injection site. injection site red and lifted. Also swelling of throat but not enough to interfere with breathing. Just swallowing. Have not felt the need to go to the hospital yet.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 64 year old female patient with allergy to codeine, rheumatoid arthritis, hepatitis B, hyperlipidemia, hypertension, latent tuberculosis, chronic renal insufficiency, stroke, myocardial infarction, venous stasis, eczema and anemia. The patient's medical history included right-sided Carotid endarterectomy (CEA). On 14-OCT-2013 the patient was vaccinated with ZOSTAVAX (route, dose and lot # were unknown). The physician assistant reported that a patient almost lost her voice within 24 hours after receiving ZOSTAVAX on 14-OCT-2013. The physician assistant reported that the patient almost lost their voice becoming very hoarse. The physician assistant reported that the patient continued to have trouble with "phonation" and her voice was sometimes very weak, but the physician assistant stated it was getting better. None of treatment was given for adverse event. None of lab diagnostics studies was performed. The patient sought medical attention via contacting physician assistant. Upon internal review, loss of voice was considered to be a medically significant event. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a male patient who is in his early 50 years age. Drug reactions/allergies reported as none. On an unknown date the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (dosage and lot # unspecified). The physician reported that the patient had a titer level drawn on an unspecified date after receiving the unspecified hepatitis B vaccination and the lab results showed a low titer below 10. No treatment received and the event was not recovered. The patient sought medical attention. No further information was provided. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from license practical nurse refers to a patient of unknown age and gender. On 11-FEB-2014 the patient was vaccinated with expired dose of RECOMBIVAX HB with lot # 0231AA and expiry date 14-OCT-2013 (dose unit and route unknown). No adverse event was reported. The outcome of received a dose of expired RECOMBIVAX HB and no adverse event was unknown. No further information was provided. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Biopsy, Petechiae, Platelet count normal
Clinical narrative: Petechial rash at abdomen and thorax, ED for r/o TTP. Biopsied for suspected vasculitis. Did recover without apparent sequelae.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Vasculitis
Clinical narrative: Petechial rash at abdomen and thorax, ED for r/o TTP. Biopsied for suspected vasculitis. Did recover without apparent sequelae.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On 09-AUG-2013 the patient was vaccinated with GARDASIL (dose 1) (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On 25-NOV-2013 the patient was vaccinated with GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown) dose 2. No adverse events were reported. Action taken with the therapy with GARDASIL was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. No product quality issue was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This spontaneous report was received from a female consumer of unknown age regarding herself. On an unknown date in 2014 (stated as a couple of days ago), the patient was administered with a dose of ZOSTAVAX. On an unknown date in 2014, the patient was sore at the injection site and also developed a little rash around the injection site. The outcome of sore at the injection site and little rash around the injection site was reported as not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received via a field employee from a physician refers to a male patient of unknown age. On 09-FEB-2014 (stated as 2 days ago), the patient was administered with a dose of ZOSTAVAX. Approximately on an unknown date in February 2014, the patient developed a zoster like rash post vaccination. The zoster like rash was on 3 dermatomes, which included the back, abdomen and leg (unspecified which leg). The patient sought medical attention and went to physician's office. The outcome of zoster like rash post vaccination was reported as not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 23-JAN-2014 the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml injection, subcutaneously, left arm (lot # J011882, expiration date 04-JAN-2015). On 25-JAN-2014 the patient experienced an injection site reaction involving tenderness, swelling and pox-like blisters around injection site. The patient sought medical attention and was seen by her physician who treated with cold compresses and cephalexin. None lab diagnostics were performed. The outcome of events was not reported. The relatedness between vaccination with ZOSTAVAX and events was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to two patients of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23 injection (dose number, route, lot number and expiry date unknown). On an unknown date the two patients experienced severe swelling at the injection site after administration of PNEUMOVAX23. Both patients sought medical attention. The outcome of severe swelling at the injection site was reported as recovered/resolved. No further information was provided. Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 31 year old female patient. On approximately 13-AUG-2012 (also reported as a year and a half ago) the patient was vaccinated with first dose of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown). No adverse events were reported. No product quality issue was reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to approximately 25 years old female patient. The physician reported that the patient who was 6 weeks pregnant with last menstrual period of approximately 30-DEC-2013 and estimated date of delivery of approximately 06-OCT-2014 received the first dose of GARDASIL (dosage and lot# unspecified) on 10-FEB-2014. Trimester of exposure was first trimester. Initial exposure to GARDASIL was at 6 weeks. The pregnancy outcome was pending. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a field representative via a physician refers to a 71 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# and route not provided). On an unknown date the patient developed shingles two years later. The physician reported that the case of shingles was "mild" and in the T12 dermatome. By the time the patient came into the physician's office on an unspecified date, the patient had shingles for two weeks. The outcome of shingles was unknown. No PQC (product quality complaint) involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 year old female patient. The patient has no known allergies. On 04-FEB-2014, the patient was vaccinated with ZOSTAVAX lot number was reported as J011550 with expiry date of 19-DEC-2014. 07-FEB-2014, patient developed an injection site reaction following vaccination with ZOSTAVAX. She developed a red lump at the injection site with a slight fever. The patient sought medical attention by contacting pharmacist. The patient treated the injection site reaction with ice packs. No lab diagnostics were performed. The outcome of red lump at the injection site and injection site reaction was reported as recovered/resolved on 10-FEB-2014. The outcome of slight fever was unknown. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 4 month old male patient. On an unknown date patient was vaccinated with first dose of ROTATEQ (strength, dose unit, lot number and expiry date unknown). On 10-FEB-2014 the patient was vaccinated with second dose of ROTATEQ suspension, 2 ml with lot # J008385 and expiry date unknown, orally. Other suspect therapies included PENTACEL with lot# C4658AA (expiry date unknown) and PCV13, lot # H41948 (expiry date unknown). Concomitant therapies included amoxicillin (manufacture unknown). On 10-FEB-2014, after 45 minutes of vaccination with ROTATEQ, patient developed rash on both sides of his mouth, two spots on his trunk and a rash at the site that the PENTACEL was administered. On the same day patient sought medical attention and was administered with dexamethasone (manufacture unknown) for events and the rash started to clear. At home patient's mother gave BENADRYL to the patient after the dexamethasone (manufacture unknown). The outcome of rash on both sides of his mouth, a rash on injection site of PENTACEL and two spots on his trunk was reported as recovering/resolving. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a child patient of unknown age (also reported as pediatric patient). On 11-FEB-2014 the patient was vaccinated with VAQTA, 0.5 ml, intramuscularly (lot number 0368AA and expiry date 11-JAN-2014) (dosing regimen and frequency unknown) expired drug. No adverse events were reported. No product quality issue was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unkonwn date the patient was vaccinated with ZOSTAVAX (dose, route and lot# not reported). It was reported that the patient was having shingles on an unknown date. The outcome of the event was unknown. It was unknown whether the patient sought medical attention. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Rash generalised, Varicella, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 15 months old male patient. On 18-OCT-2013 the patient was vaccinated with PROQUAD (merck) (lot number J005177, expiration date 03-NOV-2014) (dose and route of administration were not reported). The physician reported that he had a patient who was administered with PROQUAD (merck) and was exposed to a child suffering from chickenpox and subsequently developed a breakthrough of chickenpox with the rash occurring all over his entire body on 26-JAN-2014. The patient sought medical attention via office visit. On unspecified date in 2014 the patient recovered from breakthrough of chickenpox. Relatedness between breakthrough of chickenpox and PROQUAD (merck) was unknown. Additional information has been requested.
Age: 28.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from Healthcare student refers to a 28 year old patient of unknown gender. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml, lot number and expiration date not reported) subcutaneous. There was no concomitant medication reported. The reported stated that the patient was accidentally administered ZOSTAVAX instead of VARIVAX (merck) on an unknown date. No adverse effect reported. Additional information is not expected.
Age: 64.0
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 64 year old patient (gender unknown). Patient had no history of chicken pox or vaccination for varicella. In 2008, at unspecified time, the patient was vaccinated with VARIVAX (merck) single dose. Patient's concomitant medications were not reported. On an unknown date the patient experienced negative titer for varicella. No adverse effects reported. No further information provided. The outcome of negative titer for varicella was unknown. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood bicarbonate normal, Blood culture negative, Blood electrolytes normal, Blood pH decreased, Culture urine negative
Clinical narrative: Child found pale blue limp and not breathing by parent. CPR performed. Child transported to ER. Admitted to hospital.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cyanosis, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal, Full blood count normal
Clinical narrative: Child found pale blue limp and not breathing by parent. CPR performed. Child transported to ER. Admitted to hospital.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hypotonia, Influenza virus test negative, PCO2 increased, Pallor, Respiratory arrest
Clinical narrative: Child found pale blue limp and not breathing by parent. CPR performed. Child transported to ER. Admitted to hospital.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Respiratory syncytial virus test negative, Resuscitation
Clinical narrative: Child found pale blue limp and not breathing by parent. CPR performed. Child transported to ER. Admitted to hospital.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Crying, Fall, Fatigue, Head injury, Hypotonic-hyporesponsive episode
Clinical narrative: DTaP and HIB given at 10:00 am. Became pale and tired that afternoon. Later fell forward and hit head while seated at table - either fell asleep or had hypotonic/hyporesponsive episode. Fine afterward except up crying that night.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Pallor, Somnolence
Clinical narrative: DTaP and HIB given at 10:00 am. Became pale and tired that afternoon. Later fell forward and hit head while seated at table - either fell asleep or had hypotonic/hyporesponsive episode. Fine afterward except up crying that night.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia
Clinical narrative: Information has been received from a physician via questionnaire concerning a 14 year old student female patient who on 04-FEB-2013 was vaccinated with a dose of GARDASIL, IM, lot # H012973, Exp date, March 2015. On 05-FEB-2013, the patient experienced an episode of memory loss after receiving the GARDASIL dose on 04-FEB-2013. She had of memory loss that lasted 15 sec and almost for about 1 and a half week till approximately 15-FEB-2013. The physician reported that she would be at softball field in Gym in class and not know she was it resolved in its own and currently there is no complaints. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from health professional refers to a female patient of unknown age. Patients concurrent condition and historical condition unspecified. On an unknown date, the patient was vaccinated with third dose GARDASIL (dose and frequency unspecified), intramuscular. Concomitant medication were unspecified. On an unknown date, the patient had experienced seizure (medically significant) with third dose of the patient was vaccinated with third dose GARDASIL. The outcome of the event seizure was unknown. The reporters causality assessment for the event seizure with the therapy of GARDASIL was not reported. Upon internal assessment the event seizure was considered as medically significant. This case is linked with case 1401USA010204 as sibling case. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception, Lethargy, Rotavirus test positive, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Pt had routine 2 month visit on 12/19/13 and received routine vaccines PENTACEL, PREVNAR and ROTATEQ. Mom called on evening 12/22/13. Had lethargy initially after shots then started vomiting. Went to ER and on 12/23/13 diagnosed with intussusception by ultrasound. Required surgery to resolve.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: KINRIX administered 2/11/14, morning of 2/13/14 mother called clinic dad reported redness and swelling where shot was given. Reports client feels fine and is afebrile.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Head injury, Loss of consciousness, Nausea
Clinical narrative: Patient remained seated after vaccination about 20 -30 seconds later she fell to the ground unconscious. Patient was still breathing and remained unconscious for 30 seconds. 911 was called but patient refused ambulance. She bumped her head on the way down and felt nauseous afterward. She had not eaten all day. So she then ate some cookies, crackers w/peanut butter and water. Monitored at pharmacy for 30 min.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling of injection site where PNEUMOVAX site. Redness spread down arm.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling of injection site around PNEUMOVAX site.
Age: 9.0
Sex: F
Vaccine: DTAPHEPBIP, FLU3, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt is adopted. Mother states pt real age could be anywhere from 7 - 10. Pt had no adverse events. (Pt given PEDIARIX which should only by given up to age 7 yrs).
Age: 15.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Injection site pain
Clinical narrative: (R) deltoid soreness persistent x 3 weeks s/p HPV vaccine.
Age: 50.0
Sex: F
Vaccine: FLUC3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 59.0
Sex: M
Vaccine: HEPA
Symptoms: Death, Hepatitis A, Neoplasm malignant
Clinical narrative: This case was reported by a consumer (spouse of subject) and described the occurrence of cancer in a 59-year-old male subject who was vaccinated with Hepatitis A vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of Hepatitis A vaccine (unknown details). At an unspecified time after vaccination with Hepatitis A vaccine, the subject experienced hepatitis A infection, cancer and possible vaccination failure. The subject died from cancer in September 2013. It was unknown whether an autopsy was performed. The reporter had previously reported another case with HAVRIX. See A0993321A for details on the other case. The cases have been noted as potentially legally significant.