chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Renal failure, Rhinorrhoea, Rotavirus test negative, Rubivirus test positive, Rubulavirus test positive
Clinical narrative: Information has been received from the authors in a literature article concerning a patient with VARIVAX (Merck) (manufacturer unknown), M-M-R II and methylprednisolone (manufacturer unknown) therapy. At 13 months of age, a previous healthy girl with RAG2 deficiency presented acutely with fever, jaundice, cough, rhinorrhea, diarrhea and approximately 10 erythematous papules on her torso and extremities. Preliminary studies revealed direct Coombs positive anemia and leukocytosis with granulocytes predominating. Initial treatment measures included blood transfusions, intravenous immunoglobulin (MG) and high dose methylprednisolone (manufacturer unknown) (up to 80 mg/day), leading to transient resolution of hemolysis. In addition, she developed autoimmune thrombocytopenia (nadir 25,000 platelets/1/4.L). Three weeks after onset of illness, her rash evolved into discrete 3-mm eschars; however, very few, if any new skin lesions developed. Skin biopsy revealed intranuclear inclusion bodies typical of Herpesviridae and intravenous acyclovir was initiated. Despite antiviral therapy, which later included foscarnet, her clinical status deteriorated over subsequent weeks. Obtundation ensued, and the patient died due to complications of hepatic and renal failure, disseminated intravascular coagulation and recalcitrant autoimmune hemolytic anemia. Three weeks before onset of illness, the patient received her first VARIVAX (Merck) (manufacturer unknown) (dose and route unknown), MMR (manufacturer unknown) (dose and route unknown) and hepatitis A (manufacturer unknown). There was no obvious contraindication to the administration of live virus vaccination. She had previously received all vaccinations as per the Advisory Committee on Immunization Practices (ACIP) recommended schedule, including the rotavirus series, which were well tolerated. Prior to death, vaccine strain varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry staining, respectively. Throat swabs, also obtained prior to death, detected mumps and rubella by PCR assays. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Ophthalmic examination revealed corneal dendrites with typical features of VZV infection. Autopsy demonstrated VZV dissemination in the lungs and liver as well as profound lymphoid depletion of lymph nodes and thymic tissue. VZV, mumps and rubella isolated from the patient were confined as vaccine genotypes Oka, Jeryl-Lynn and RA 27/3, respectively. The reporter considered the events to be related to VARIVAX (Merck)(manufacturer unknown), MMR (manufacturer unknown), methylprednisolone (manufacturer unknown) and hepatitis A (manufacturer unknown). Upon internal review, renal failure, hepatic failure and disseminated intravascular coagulation were considered to be medically significant. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Skin lesion, Transfusion, Varicella virus test positive, Varicella zoster virus infection, Viral test negative
Clinical narrative: Information has been received from the authors in a literature article concerning a patient with VARIVAX (Merck) (manufacturer unknown), M-M-R II and methylprednisolone (manufacturer unknown) therapy. At 13 months of age, a previous healthy girl with RAG2 deficiency presented acutely with fever, jaundice, cough, rhinorrhea, diarrhea and approximately 10 erythematous papules on her torso and extremities. Preliminary studies revealed direct Coombs positive anemia and leukocytosis with granulocytes predominating. Initial treatment measures included blood transfusions, intravenous immunoglobulin (MG) and high dose methylprednisolone (manufacturer unknown) (up to 80 mg/day), leading to transient resolution of hemolysis. In addition, she developed autoimmune thrombocytopenia (nadir 25,000 platelets/1/4.L). Three weeks after onset of illness, her rash evolved into discrete 3-mm eschars; however, very few, if any new skin lesions developed. Skin biopsy revealed intranuclear inclusion bodies typical of Herpesviridae and intravenous acyclovir was initiated. Despite antiviral therapy, which later included foscarnet, her clinical status deteriorated over subsequent weeks. Obtundation ensued, and the patient died due to complications of hepatic and renal failure, disseminated intravascular coagulation and recalcitrant autoimmune hemolytic anemia. Three weeks before onset of illness, the patient received her first VARIVAX (Merck) (manufacturer unknown) (dose and route unknown), MMR (manufacturer unknown) (dose and route unknown) and hepatitis A (manufacturer unknown). There was no obvious contraindication to the administration of live virus vaccination. She had previously received all vaccinations as per the Advisory Committee on Immunization Practices (ACIP) recommended schedule, including the rotavirus series, which were well tolerated. Prior to death, vaccine strain varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry staining, respectively. Throat swabs, also obtained prior to death, detected mumps and rubella by PCR assays. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Ophthalmic examination revealed corneal dendrites with typical features of VZV infection. Autopsy demonstrated VZV dissemination in the lungs and liver as well as profound lymphoid depletion of lymph nodes and thymic tissue. VZV, mumps and rubella isolated from the patient were confined as vaccine genotypes Oka, Jeryl-Lynn and RA 27/3, respectively. The reporter considered the events to be related to VARIVAX (Merck)(manufacturer unknown), MMR (manufacturer unknown), methylprednisolone (manufacturer unknown) and hepatitis A (manufacturer unknown). Upon internal review, renal failure, hepatic failure and disseminated intravascular coagulation were considered to be medically significant. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from the authors in a literature article concerning a patient with VARIVAX (Merck) (manufacturer unknown), M-M-R II and methylprednisolone (manufacturer unknown) therapy. At 13 months of age, a previous healthy girl with RAG2 deficiency presented acutely with fever, jaundice, cough, rhinorrhea, diarrhea and approximately 10 erythematous papules on her torso and extremities. Preliminary studies revealed direct Coombs positive anemia and leukocytosis with granulocytes predominating. Initial treatment measures included blood transfusions, intravenous immunoglobulin (MG) and high dose methylprednisolone (manufacturer unknown) (up to 80 mg/day), leading to transient resolution of hemolysis. In addition, she developed autoimmune thrombocytopenia (nadir 25,000 platelets/1/4.L). Three weeks after onset of illness, her rash evolved into discrete 3-mm eschars; however, very few, if any new skin lesions developed. Skin biopsy revealed intranuclear inclusion bodies typical of Herpesviridae and intravenous acyclovir was initiated. Despite antiviral therapy, which later included foscarnet, her clinical status deteriorated over subsequent weeks. Obtundation ensued, and the patient died due to complications of hepatic and renal failure, disseminated intravascular coagulation and recalcitrant autoimmune hemolytic anemia. Three weeks before onset of illness, the patient received her first VARIVAX (Merck) (manufacturer unknown) (dose and route unknown), MMR (manufacturer unknown) (dose and route unknown) and hepatitis A (manufacturer unknown). There was no obvious contraindication to the administration of live virus vaccination. She had previously received all vaccinations as per the Advisory Committee on Immunization Practices (ACIP) recommended schedule, including the rotavirus series, which were well tolerated. Prior to death, vaccine strain varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and immunohistochemistry staining, respectively. Throat swabs, also obtained prior to death, detected mumps and rubella by PCR assays. Stool samples submitted for viral electron microscopy were negative, including assessment for rotavirus. Ophthalmic examination revealed corneal dendrites with typical features of VZV infection. Autopsy demonstrated VZV dissemination in the lungs and liver as well as profound lymphoid depletion of lymph nodes and thymic tissue. VZV, mumps and rubella isolated from the patient were confined as vaccine genotypes Oka, Jeryl-Lynn and RA 27/3, respectively. The reporter considered the events to be related to VARIVAX (Merck)(manufacturer unknown), MMR (manufacturer unknown), methylprednisolone (manufacturer unknown) and hepatitis A (manufacturer unknown). Upon internal review, renal failure, hepatic failure and disseminated intravascular coagulation were considered to be medically significant. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Asthma, Bronchitis, Condition aggravated, Drug intolerance
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number 2015335437 for HUMIRA. This was originally reported by a consumer. This spontaneous report refers to a 61 year old female patient reporting on herself. The patient's concurrent conditions included high blood pressure and angina, both started over ten years ago. Rheumatoid arthritis which was diagnosed in 2006 or 2007 and she started taking ENBREL right away (unspecified date). The patient's medical history included sinus disorder. In approximately 2011 or 2012 (referred as "about three to four years ago"), the patient received a dose of pneumococcal vaccine (manufacturer unknown). The vaccine was purchased with the insurance, and a copay and was given at the doctor's office. Other suspect therapies included methotrexate (manufacturer unknown) which was given to take alone with ENBREL in 2011 (referred as "about four years ago"). Concomitant therapies included prednisone (manufacturer unknown), cortisone (manufacturer unknown) and ENBREL. In approximately 2011 (referred as "about 4 years ago"), the patient experienced bronchitis. Then in approximately 2012 (referred as "about 3 years ago"), she developed asthma because of her "sinuses". In approximately 2013 (referred as "about 2 years ago"), the patient experienced pneumonia. She was in the intensive care unit for two days, and was hospitalized for a total of five days. She completely recovered from the pneumonia on unknown date. A year and a half to 2 years after vaccination (2013 or 2014), her doctor said that she was probably developing rheumatoid arthritis lungs. Since on an unknown date, the patient could not tolerate the methotrexate (manufacturer unknown). It was described as the drug was tearing up her stomach, also described as "building up in her stomach". In approximately 2013, after taking methotrexate (manufacturer unknown) for about two years, the therapy was discontinued and replaced with XELJANZ which worked well for the patient. The patient did not have any pain. On 14-SEP-2015, blood test Hepatitis C: everything was fine. At the time of this report, the outcome of pneumonia and abdominal discomfort was reported as recovered. The outcome of drug intolerance, vaccination failure and rheumatoid arthritis was unknown. The outcome of asthma and bronchitis was reported as ongoing (not recovered). The reporter considered drug intolerance to be related to methotrexate (manufacturer unknown). The responsible physician considered that the events were not related to pneumococcal vaccine (manufacturer unknown). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Hepatitis C test negative, Intensive care, Pneumonia, Rheumatoid arthritis, Vaccination failure
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number 2015335437 for HUMIRA. This was originally reported by a consumer. This spontaneous report refers to a 61 year old female patient reporting on herself. The patient's concurrent conditions included high blood pressure and angina, both started over ten years ago. Rheumatoid arthritis which was diagnosed in 2006 or 2007 and she started taking ENBREL right away (unspecified date). The patient's medical history included sinus disorder. In approximately 2011 or 2012 (referred as "about three to four years ago"), the patient received a dose of pneumococcal vaccine (manufacturer unknown). The vaccine was purchased with the insurance, and a copay and was given at the doctor's office. Other suspect therapies included methotrexate (manufacturer unknown) which was given to take alone with ENBREL in 2011 (referred as "about four years ago"). Concomitant therapies included prednisone (manufacturer unknown), cortisone (manufacturer unknown) and ENBREL. In approximately 2011 (referred as "about 4 years ago"), the patient experienced bronchitis. Then in approximately 2012 (referred as "about 3 years ago"), she developed asthma because of her "sinuses". In approximately 2013 (referred as "about 2 years ago"), the patient experienced pneumonia. She was in the intensive care unit for two days, and was hospitalized for a total of five days. She completely recovered from the pneumonia on unknown date. A year and a half to 2 years after vaccination (2013 or 2014), her doctor said that she was probably developing rheumatoid arthritis lungs. Since on an unknown date, the patient could not tolerate the methotrexate (manufacturer unknown). It was described as the drug was tearing up her stomach, also described as "building up in her stomach". In approximately 2013, after taking methotrexate (manufacturer unknown) for about two years, the therapy was discontinued and replaced with XELJANZ which worked well for the patient. The patient did not have any pain. On 14-SEP-2015, blood test Hepatitis C: everything was fine. At the time of this report, the outcome of pneumonia and abdominal discomfort was reported as recovered. The outcome of drug intolerance, vaccination failure and rheumatoid arthritis was unknown. The outcome of asthma and bronchitis was reported as ongoing (not recovered). The reporter considered drug intolerance to be related to methotrexate (manufacturer unknown). The responsible physician considered that the events were not related to pneumococcal vaccine (manufacturer unknown). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARZOS
Symptoms: Liver transplant, Polymerase chain reaction positive, Rash vesicular, Scar
Clinical narrative: Information has been received from a physician referring to a 16 year old female patient. The patient's medical history included liver transplant on an unspecified date when she was an infant. On an unknown date (reported as "years ago") the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# were unknown). Concomitant medication included acyclovir. On an unknown date after the vaccination, the patient had her second liver transplant. On 02-NOV-2015 the patient developed a "varicella zoster virus (VZV)-like rash". A polymerase chain reaction (PCR) swab sample was done on 05-NOV-2015, revealing a low positive result with a cycle threshold (CT) value of 39.2. The reporter stated that the rash developed along the scar line from the liver transplant (onset date of scar was unknown). At the time of reporting, the outcome of the events was unknown. Upon internal review, the event "liver transplant" was considered as medically significant. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cough, Dizziness, Dyspnoea, Injection site erythema, Injection site inflammation
Clinical narrative: Patient reports delayed s/s patient reports SOB, mild fever, dizziness, cough, inflammation and redness to right deltoid. Patient was seen by PCP. Apply ice to upper extremity, BACTRIM PO x 2 daily, for 10 days, BENADRYL gel OTC daily, cetirizine 10 mg PO daily. Ret to pulmon.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pyrexia
Clinical narrative: Patient reports delayed s/s patient reports SOB, mild fever, dizziness, cough, inflammation and redness to right deltoid. Patient was seen by PCP. Apply ice to upper extremity, BACTRIM PO x 2 daily, for 10 days, BENADRYL gel OTC daily, cetirizine 10 mg PO daily. Ret to pulmon.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: Two days following vaccination. pt. experienced soreness and redness at vaccine site -9 x 12 cm - no itching - no infection - no bulls eye, no petechia.
Age: 0.19
Sex: F
Vaccine: DTAP
Symptoms: Injection site rash
Clinical narrative: Child developed severe rash involving entire (R) upper leg lasting > 3 days.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: (L) deltoid -> redness and pain and tenderness over the injection site few hours earlier TDAP on 11/13/2015.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Didn't hurt where shot went in, pain localized to shoulder (front of shoulder). No bruising, redness, rash (just pain) treated with prednisone 20mg 2 qd x 5 days. Following up w/PCP.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Hives/rash over back/trunk.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Presyncope
Clinical narrative: Pt had a vasovagal episode and remained in clinice for 30 min observation.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of rash in a adult female patient who received FLULAVAL Quadrivalent (batch number H33J2, expiry date May 2016). On 7th October 2015, the patient received the 1st dose of FLULAVAL Quadrivalent .5 ml. On 8th October 2015, 1 days after receiving FLULAVAL Quadrivalent, the patient experienced rash, injection site swelling and injection site redness. On 12th October 2015, the outcome of the rash, injection site swelling and injection site redness were recovered/resolved. The reporter considered the rash, injection site swelling and injection site redness to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The patient was an employee of the facility. The nurse reported that the next day after receiving FLULAVAL QIV, the patient experienced a severe injection site reaction with increased swelling in the upper deltoid. The deltoid was red (injection site redness), swollen (injection site swelling) and a noticeable rash on the entire left arm. The symptoms lasted for 3 days until they resolved.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 30-year-old female patient who received ENGERIX B adult (batch number 54RS5, expiry date 11th October 2016). This case was associated with a product complaint. Co-suspect products included ENGERIX B adult (batch number 995J5, expiry date 6th February 2017) and ENGERIX B adult (batch number 24JP3, expiry date 10th July 2017).  On 3rd November 2014, the patient received the 1st dose of ENGERIX B adult. On 4th December 2014, the patient received the 2nd dose of ENGERIX B adult. On 1st June 2015, the patient received the 3rd dose of ENGERIX B adult. On 1st June 2015, not applicable after receiving ENGERIX B adult and ENGERIX B adult, not applicable after receiving ENGERIX B adult and ENGERIX B adult and an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too long. On 21st August 2015, the patient experienced therapy non-responder. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long and pharmaceutical product complaint were unknown. The reporter considered the therapy non-responder to be possible related to ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details provided were as follows: This case was previously reported to manufacturer. This case was one of the seven reports reported by an occupational nurse for patients tested negative for Hepatitis B titres following vaccination with ENGERIX B (see cases US2015GSK136757, US2015GSK136758, US2015GSK136759, US2015GSK136760, US2015GSK136761 and US2015GSK136763). The caller reported that, they had their laboratory equipment recalibrated and the tests were rerun and results were same or even lower titres. All of the seven patients were new hires at the company and so the reporter was following them. This case concerned to the 7th patient. On 4th December 2015, the patient received the 2nd dose of ENGERIX B adult. On 1st June 2015, the patient received the 3rd dose, which led to lengthening of the vaccination schedule. On 21st August 2015, 291 days after receiving 1st dose of ENGERIX B adult, 260 days after receiving 2nd dose of ENGERIX B adult and 81 days after receiving 3rd dose of ENGERIX B adult, the patient underwent test for Hepatitis B antibodies and it was found to be negative (0.3), causing the patient to be a non-responder to the therapy.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a adult female patient who received FLULAVAL Quadrivalent (batch number H33J2, expiry date May 2016(. On 7th October 2015, the patient received the 1st dose of FLULAVAL Quadrivalent .5 ml. On 8th October 2015, 1 days after receiving FLULAVAL Quadrivalent, the patient experienced injection site redness, rash and injection site swelling. On 12th October 2015, the outcome of the injection site redness, rash and injection site swelling were recovered/resolved. The reporter considered the injection site redness, rash and injection site swelling to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The reported injection site was left deltoid. The nurse reported that next day after receiving FLULAVAL QIV, the patient experienced a severe injection site reaction with increased swelling in the entire deltoid. The deltoid was red (injection site redness), swollen (injection site swelling and a rash on the left arm. On Monday, 12th October 2015, the patient was checked and there was still a small red area around the injection site that was firm under the skin. The side effects lasted three days until they resolved.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. The pharmacist reported that on unknown dates the patients "might" have received doses of improperly stored VARIVAX (Merck) (lot#, dose and route were unknown). Concomitant medications were not provided. No adverse effects were reported. This is one of three reports received from the same reporter (other linked case # 1511USA009275 and 1511USA009327). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. The pharmacist reported that on unknown dates the patients "might" have received doses of improperly stored PROQUAD (Merck) (lot#, dose and route were unknown). Concomitant medications were not provided. No adverse effects were reported. This is one of three reports received from the same reporter (other linked case # 1511USA009326 and 1511USA009327). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age. Between 05-NOV-2015 and 11-NOV-2015, the patients were vaccinated with improperly stored VAQTA (lot # L018499, expiration dates 25-FEB-2017 and L028666, expiration date 04-NOV-2016, strength, dose and route were unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age. Between 05-NOV-2015 and 11-NOV-2015, the patients were vaccinated with improperly stored M-M-R II (lot # L002242, expiration date 21-JAN-2017, strength, dose and route were unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a 62 year old female patient referring to herself. The patient's medical history included chickenpox and pneumonia. The patient was allergic to amoxicillin. On 04-NOV-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# L033707 with expiration date of 18-MAY-2017, 1 shot, once, strength unknown, intramuscular) for prevention of pneumonia. Concomitant medication included ZYRTEC (genetic). The next day on 05-NOV-2015, after receiving the vaccine the patient did not feel good and felt "drained" with fevers and chills. The patient also stated that her arm ached and was hot, and covered with welts from shoulder to elbow and in between. The patient sought medical attention by speaking to physician's office. BENADRYL, ibuprofen and cortisone cream were given for the treatment. No lab diagnostics were performed. The patient was not recovered from the event. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Urticaria
Clinical narrative: Information has been received from a 62 year old female patient referring to herself. The patient's medical history included chickenpox and pneumonia. The patient was allergic to amoxicillin. On 04-NOV-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# L033707 with expiration date of 18-MAY-2017, 1 shot, once, strength unknown, intramuscular) for prevention of pneumonia. Concomitant medication included ZYRTEC (genetic). The next day on 05-NOV-2015, after receiving the vaccine the patient did not feel good and felt "drained" with fevers and chills. The patient also stated that her arm ached and was hot, and covered with welts from shoulder to elbow and in between. The patient sought medical attention by speaking to physician's office. BENADRYL, ibuprofen and cortisone cream were given for the treatment. No lab diagnostics were performed. The patient was not recovered from the event. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB, lot # K016005, expiration date 27-AUG-2016 (dose and route of administration were not reported). No adverse effects were reported. Follow up information has been received from the Licensed Practical Nurse (initial reported as Licensed Vocational Nurse) during a telephone call on 13-NOV-2015 concerning one of the multiple patients of unknown age and gender. On 08-JUL-2015, the patient vaccinated with the improperly stored RECOMBIVAX HB. Additional information has been requested. Patient's information, products, events and narrative were updated.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 19-OCT-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L009214, expiration 17-MAR-2017, dose and route were not reported) (incorrect product storage). No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 16-OCT-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L009214, expiration 17-MAR-2017, dose and route were not reported). No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Feeling abnormal, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative regarding a 60 year old male patient. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 02-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23, (dose, route, anatomical location, lot number and expiration date were not reported). The patient's concomitant therapies included an unspecified flu shot a few days prior to the PNEUMOVAX 23. On 05-OCT-2015 (reported as three days and six hours after receiving PNEUMOVAX 23), the patient presented with an unspecified welt on his back (urticaria). Additionally, on an unspecified date described as "couple of weeks" the patient felt as he had fluid on his lungs. The patient sought medical attention by went to the physician office and the physician prescribed an unspecified albuterol, no lab diagnostics were performed. At the time of the report, the outcome of the patient presented with an unspecified welt on his back was recovered described as the welt lasted four days and the outcome of the patient felt as he had fluid on his lungs was unknown. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. On 08-AUG-2015, the patient vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # K016005, expiration date 27-AUG-2016, dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. On 08-AUG-2015, the patient vaccinated with improperly stored dose of RECOMBIVAX HB (lot # K016005, expiration date 27-AUG-2016, dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB, lot # K016005, expiration date 27-AUG-2016 (dose and route of administration were not reported). No adverse effects were reported. Follow up information has been received from the Licensed Practical Nurse (initial reported as Licensed Vocational Nurse) during a telephone call on 13-NOV-2015 concerning one of the multiple patients of unknown age and gender. On 03-AUG-2015, the patient vaccinated with the improperly stored RECOMBIVAX HB. Additional information has been requested. Patient's information, products, events and narrative were updated.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report was received from a Doctor of Pharmacy and refers to a 64 year old female patient with shrimp and chloramphenicol allergy and no pertinent medical history. On 01-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L015417 (expiration date 01-AUG-2016) (route and dose not reported). There was no concomitant medication. On 02-NOV-2015, the patient reported to the pharmacist that she had developed on the same date a "rash" that was "hard and red and it was three to four inches wide". The patient then applied an ice pack to the area and took an unspecified dose of ibuprofen and BENADRYL (unspecified dose and frequency). Then, on 03-NOV-2015, the patient reported to the pharmacist that unspecified "blisters" appeared around the injection site as well. No laboratory testing were performed. The patient sought medical attention by calling the pharmacist. At the time of the report the patient had not recovered from the "rash that was hard and red" or from the "blisters" that appeared around the injection site as well. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The medical history, drug reactions and allergies of the patients were not reported. On unknown dates, the unspecified patients received improperly stored doses of RECOMBIVAX HB, lot # K026666, expiration date 22-OCT-2016 (dose, frequency and route were not reported. No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 11-AUG-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 25-AUG-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of nausea in a 37-year-old female patient who received FLUARIX Quadrivalent (batch number XC23D, expiry date 30th June 2016). On 6th October 2015, the patient received the 1st dose of FLUARIX Quadrivalent .5 ml. On 6th October 2015, 45 min after receiving FLUARIX Quadrivalent, the patient experienced nausea, fever, vomiting, headache and chills. The patient was treated with antibiotics nos (Iv Antibitics (Nos)), antiemetics and antinauseants (Antiemetic) and analgesic, nos (Pain Medication). On an unknown date, the outcome of the nausea, vomiting, headache and chills were unknown and the outocme of the fever was not reported. It was unknown if the reporter considered the nausea, fever, vomiting, headache and chills to be related to FLUARIX Quadrivalent. Additional details were provided as follows: This case was previously reproted to the manufacturer. This case was reported by a nurse via email to GlaxoSmithKline's sale representative. The reproting nurse was the director of nuring. The nurse made a comment that theygave a FLUARIX QIV vaccine to the paitnet, who was one of their employees. About 1 hr (approximately 45 minutes) after the vaccination with FLUARIX QIV, the patient experienced nausea, headache and chills. The patient's body temperature raised up to 103 degrees F. On 6th October 2015, less than a day after vacciantion, the patient eventually vomited. The patietn was started on Intravenous therapy, given an anti nausea regimen, some unspecified pain medication and was then transported to the hospital becasue the labs at the nursing were off. On the day of reporting, in the afternoon, the supervising nurse called to report that the patient was sent for blood work and clarified that the labs were closed. It was unknown if patient stayed overnigh at the hospital. No additioanl details were provided.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a 59-year-old female patient who received FLULAVAL QUADRIVALENT (batch number C92E7, expiry date 30th June 2016). On 2nd October 2015, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 2nd October 2015, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site induration. On 3rd October 2015, the patient experienced injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site induration, injection site erythema and injection site tenderness were not recovered/not resolved. The reporter considered the injection site induration, injection site erythema and injection site tenderness to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor and a health department. The patient herself was a healthcare professional. The patient experienced induration of 4 x 3 cm at the injection site (left deltoid). On 3rd October 2015, 1 day after receiving the vaccine, the patient experienced erythema and tenderness (pain) at the injection site along with arm pain. No other details were provided at the time of the reporting. This case has been linked to other two patients for experiencing induration after receiving the vaccine from the same vial (see cases US2015142208 and US2015142209).
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The medical history, drug reactions and allergies of the patients were not reported. On unknown dates, the unspecified patients received improperly stored doses of ROTATEQ by oral route, lot # K015816, expiration date 29-MAY-2016 (dose and frequency were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 28-AUG-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 16-OCT-2015, the patient received an improperly stored dose of RECOMBIVAX HB, lot # K0110535, expiration date 27-AUG-2016 (dose, frequency and route were not reported). On the same day, the patient also received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported), also. No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 17-AUG-2015, the patient received an improperly stored dose of GARDASIL, lot # K005881, expiration date 14-JAN-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 01-SEP-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 08-SEP-3025, the patient received an improperly stored dose of ROTATEQ by oral route, lot # K005396, expiration date 28-FEB-2016 (dose and frequency were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 31-AUG-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The medical history, drug reactions and allergies of the patients were not reported. On unknown dates, the unspecified patients received improperly stored doses of GARDASIL 9, lot # L011846, expiration date 16-JUN-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The medical history, drug reactions and allergies of the patients were not reported. On unknown dates, the unspecified patients received improperly stored PEDVAXHIB lot # J014279, expiration date 16-SEP-2016 and lot # K015462, expiration date 10-JUL-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 13-AUG-2015, the patient received an improperly stored dose of GARDASIL, lot # K005881, expiration date 14-JAN-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 28-SEP-2015, the patient received an improperly stored dose of GARDASIL, lot # K005881, expiration date 14-JAN-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.