chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding unspecified number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unknown date, the patients were vaccinated with PROQUAD which was improperly stored. No concomitant medication was reported. No adverse event was reported. No product quality complaint was involved. The outcome of event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding unspecified number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX which was improperly stored. No concomitant medication was reported. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 12 month old female patient. On an unknown date the patient was vaccinated at pediatrician's office with the 2 doses of M-M-R II (lot #, strength and route were not reported) and concomitantly with unspecified varicella  virus vaccine (manufacturer unknown) (lot #, strength, frequency and route were not reported) instead of 1 dose of M-M-R II, 1 dose of unspecified varicella virus vaccine (manufacturer unknown) and 1 dose of hepatitis A. The patient sought medical attention at office. The outcome of patient's event was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding two patients of unknown age and gender. There was no information patients pertinent medical history and drug reactions or allergies. On 17-MAR-2015, the patients were vaccinated with improperly stored doses of ZOSTAVAX (product lot#, expiry date, route, dose not reported). No adverse events were reported. There was no product quality complaint involved. The outcome of the events were unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse regarding a patient of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. The nurse reported that on 14-MAY-2015, the patient wad inadvertently vaccinated with 0.5 milliliter (ml) of ZOSTAVAX subcutaneously. (Product, lot#, expiry date not reported). No adverse effects was reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information is not expected as there was no consent to contact the reporter.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Cough, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Cough, wheezing, headache, chills, fever, scratchy throat. Redness/swelling at inj site. Got the inj at 10:45 AM and same day at night had the reaction. Given Amoxicillin/Clavulanate Potassium 875-125 mg.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Throat irritation, Wheezing
Clinical narrative: Cough, wheezing, headache, chills, fever, scratchy throat. Redness/swelling at inj site. Got the inj at 10:45 AM and same day at night had the reaction. Given Amoxicillin/Clavulanate Potassium 875-125 mg.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a currently 34 year old female medical student who was reporting on herself. The patient had no pertinent medical history and no know drug allergies. In 2015 (exact date was unknown), the patient performed a pregnancy test with negative result, and after that, on 06-MAY-2015, the patient was vaccinated with the first 0.5 ml dose of (Oka/Merck) VARIVAX, lot #, expiration date and route of administration unspecified. The patient did not take any concomitant medication. After receiving the vaccine, the patient did not have her menstrual cycle for the month of May and was concerned that she could be pregnant. On 11-MAY-2015, the patient performed another pregnancy test and its result was positive. The patient became pregnant with last menstrual period (LMP) of 12-APR-2015 and estimated due date (EDD) was calculat3ed as 17-JAN-2016. It was reported that the patient did not receive any treatment for the event. The outcome of the pregnancy was pending and the fetal outcome was unknown. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Needle issue, Syringe issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated 3with a dose of ZOSTAVAX (lot number and expiration date were not provided). No concomitant therapies were reported. The reporting pharmacist stated that when he went to inject the vaccine, it leaked out the end of the barrel (incorrect dose administered and product container issue). The pharmacist believed the needle was on tight but maybe it came loose in the patient's arm (needle issue). Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse via a company representative refers to an approximately 78 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 18-MAY-2015, the patient was vaccinated with PNEUMOVAX23 (lot # 1001311, expiry date 16-JUL-2016) in the left arm. On an unknown date in May 2015, when the patient took the vaccine in the left arm it became swollen, red, painful, and warm to the touch around the sight of the injection. The patient was treated with KENALOG, prednisone and erythromycin (unspecified manufacturers). The outcome of the events was unknown. The reporter did not provide the relatedness of the events with PNEUMOVAX23. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 49 year old female patient. No pertinent medical history, concurrent conditions or concomitant medications were reported. On an unknown date, the pharmacist vaccinated the patient with the last dose of GARDASIL in his pharmacy. The dates of administration for any previous doses of GARDASIL were unknown. The pharmacist did not provide any further explanation of the last dose administered to patient. No adverse events were reported. The outcome of the events were unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On 16-JAN-2015 the patient was vaccinated with VAQTA dose 1, intramuscularly, (strength, dose, frequency, lot number, expiration date and indication were not reported). On 29-APR-2015 the patient was inadvertently administered with VAQTA dose 2, intramuscularly, (strength, dose, frequency, lot number, expiration date and indication were not reported). There was no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 14-MAY-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot #, route of administration and dose were not reported). No adverse effects were reported. This is one of 3 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 14-MAY-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot #, route of administration and dose were not reported). No adverse effects were reported. This is one of 3 reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 14-MAY-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot #, route of administration and dose  were not reported). No adverse effects were reported. This is one of 3 reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. The patient's current conditions included drug allergy to macrolide antibiotics and codeine. On 04-MAY-2015, the patient was vaccinated with ZOSTAVAX, subcutaneously (lot number K018171 and expiration date of 23-OCT-2015) at 0.65 ml. Concomitant therapies included estrogens, PREMARIN, lovastatin (unknown manufacturer) and hydrochlorothiazide (unknown manufacturer). Approximately in May 2015 the patient experienced a burning sensation when she touched the injection site (when she did not touch the site, she did not experience burning) and she was experienced pruritus at the injection site. No rash or lesions were present. The patient sought medical attention and placed a call to pharmacist. No lab diagnostics procedures were performed. No treatment was received for the events. The outcome of the events was reported as not recovered. The causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date since 23-APR-2015, the patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ (lot # K017572, expiration date: 18-MAR-2016 and lot # K013868, expiration date: 27-MAY-2016) (dose and route were not reported). No concomitant therapies were provided. No adverse effects were reported. 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: Information has been received from a nurse referring to an unspecified number of patients of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with a dose of improperly stored ROTATEQ. No adverse effects were reported. It was unspecified if the patients sought medical attention. Follow up information has been received on 29-APR-2015 from a healthcare worker. It was reported that more unspecified patients (unspecified number) received doses of improperly stored ROTATEQ (dose, frequency, route of administration, lot # and expiration dates unknown). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested. General details and analysis were updated.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 21-MAY-2015, the patient was inadvertently vaccinated with one expired dose of GARDASIL (lot # H015555 and expiration date 13-APR-2015). No adverse effects were reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Abdominal pain, Ileus, Polymerase chain reaction positive, Rash, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old male patient who was enrolled in a Varicella Zoster Virus (VZV) Identification Program. The patient's concurrent conditions included autism, delayed puberty, Basedow's disease, hydrocephalus, hypothyroidism, Adrenal insufficiency (iatrogenic), juvenile idiopathic arthritis, chronic respiratory disease and chronic kidney disease. The patient was allergic to Beef, Casein, Cashew, Chloral hydrate, COBAN 60, Lactose, Lactulose, Milk, Nuts, Peanut, THORAZINE and Wheat. The patient's medical history included gastrooesophageal reflux disease, Visceral hyperalgesia, premature birth (at 24 weeks gestation) and Oral aversion. Concomitant therapies included Acetaminophen, Albuterol, Baclofen, Budesonide, Cholecalciferol, Citalopram, Diazepam PRN, AQUAPHOR topical ointment, Etanercept, Gentamicin, Histrelin implant, Hydrocortisone (enteral), Ipratropium, Levothyroxine, Meloxicam, Mupirocin, Occular lubricant, Omeprazole, Risperidone, Simethicone, Sodium chloride inhalation and Sodium chloride nasal spray. On 17-MAY-2002 the patient was vaccinated with the first dose of VARIVAX (dose/route/frequency unknown). Following the first vaccination the patient presented disseminated rash. On 28-JUL-2014 the patient was vaccinated with the second dose of VARIVAX. On an unknown date in November 2014 the patient experienced prolonged intestinal ileus (first episode) with severe abdominal pain which alleviated with gabapentin and nalbuphine. On 01-FEB-2015 the patient experienced second episode of prolonged ileus. The Polymerase Chain Reaction (PCR) test of the saliva performed on 26-FEB-2015 was positive for VZV. The patient was treated with Valacyclovir (started 3 weeks after symptom onset of February 2015 ileus). The outcome of first occurrence of prolonged intestinal ileus was reported as resolved but the second episode was ongoing at the time of this report. The outcome of disseminated rash is unknown. Reporter's causality was unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Aerophagia, Blood thyroid stimulating hormone increased
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old male patient who was enrolled in a Varicella Zoster Virus (VZV) Identification Program. The patient's concurrent conditions included autism, delayed puberty, Basedow's disease, hydrocephalus, hypothyroidism, Adrenal insufficiency (iatrogenic), juvenile idiopathic arthritis, chronic respiratory disease and chronic kidney disease. The patient was allergic to Beef, Casein, Cashew, Chloral hydrate, COBAN 60, Lactose, Lactulose, Milk, Nuts, Peanut, THORAZINE and Wheat. The patient's medical history included gastrooesophageal reflux disease, Visceral hyperalgesia, premature birth (at 24 weeks gestation) and Oral aversion. Concomitant therapies included Acetaminophen, Albuterol, Baclofen, Budesonide, Cholecalciferol, Citalopram, Diazepam PRN, AQUAPHOR topical ointment, Etanercept, Gentamicin, Histrelin implant, Hydrocortisone (enteral), Ipratropium, Levothyroxine, Meloxicam, Mupirocin, Occular lubricant, Omeprazole, Risperidone, Simethicone, Sodium chloride inhalation and Sodium chloride nasal spray. On 17-MAY-2002 the patient was vaccinated with the first dose of VARIVAX (dose/route/frequency unknown). Following the first vaccination the patient presented disseminated rash. On 28-JUL-2014 the patient was vaccinated with the second dose of VARIVAX. On an unknown date in November 2014 the patient experienced prolonged intestinal ileus (first episode) with severe abdominal pain which alleviated with gabapentin and nalbuphine. On 01-FEB-2015 the patient experienced second episode of prolonged ileus. The Polymerase Chain Reaction (PCR) test of the saliva performed on 26-FEB-2015 was positive for VZV. The patient was treated with Valacyclovir (started 3 weeks after symptom onset of February 2015 ileus). The outcome of first occurrence of prolonged intestinal ileus was reported as resolved but the second episode was ongoing at the time of this report. The outcome of disseminated rash is unknown. Reporter's causality was unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Central venous catheterisation, Diarrhoea, Enema administration, Feeding tube user, Gastrostomy
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old male patient who was enrolled in a Varicella Zoster Virus (VZV) Identification Program. The patient's concurrent conditions included autism, delayed puberty, Basedow's disease, hydrocephalus, hypothyroidism, Adrenal insufficiency (iatrogenic), juvenile idiopathic arthritis, chronic respiratory disease and chronic kidney disease. The patient was allergic to Beef, Casein, Cashew, Chloral hydrate, COBAN 60, Lactose, Lactulose, Milk, Nuts, Peanut, THORAZINE and Wheat. The patient's medical history included gastrooesophageal reflux disease, Visceral hyperalgesia, premature birth (at 24 weeks gestation) and Oral aversion. Concomitant therapies included Acetaminophen, Albuterol, Baclofen, Budesonide, Cholecalciferol, Citalopram, Diazepam PRN, AQUAPHOR topical ointment, Etanercept, Gentamicin, Histrelin implant, Hydrocortisone (enteral), Ipratropium, Levothyroxine, Meloxicam, Mupirocin, Occular lubricant, Omeprazole, Risperidone, Simethicone, Sodium chloride inhalation and Sodium chloride nasal spray. On 17-MAY-2002 the patient was vaccinated with the first dose of VARIVAX (dose/route/frequency unknown). Following the first vaccination the patient presented disseminated rash. On 28-JUL-2014 the patient was vaccinated with the second dose of VARIVAX. On an unknown date in November 2014 the patient experienced prolonged intestinal ileus (first episode) with severe abdominal pain which alleviated with gabapentin and nalbuphine. On 01-FEB-2015 the patient experienced second episode of prolonged ileus. The Polymerase Chain Reaction (PCR) test of the saliva performed on 26-FEB-2015 was positive for VZV. The patient was treated with Valacyclovir (started 3 weeks after symptom onset of February 2015 ileus). The outcome of first occurrence of prolonged intestinal ileus was reported as resolved but the second episode was ongoing at the time of this report. The outcome of disseminated rash is unknown. Reporter's causality was unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Human metapneumovirus test positive, Ileus, Ileus paralytic, Intestinal dilatation, Jejunostomy
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old male patient who was enrolled in a Varicella Zoster Virus (VZV) Identification Program. The patient's concurrent conditions included autism, delayed puberty, Basedow's disease, hydrocephalus, hypothyroidism, Adrenal insufficiency (iatrogenic), juvenile idiopathic arthritis, chronic respiratory disease and chronic kidney disease. The patient was allergic to Beef, Casein, Cashew, Chloral hydrate, COBAN 60, Lactose, Lactulose, Milk, Nuts, Peanut, THORAZINE and Wheat. The patient's medical history included gastrooesophageal reflux disease, Visceral hyperalgesia, premature birth (at 24 weeks gestation) and Oral aversion. Concomitant therapies included Acetaminophen, Albuterol, Baclofen, Budesonide, Cholecalciferol, Citalopram, Diazepam PRN, AQUAPHOR topical ointment, Etanercept, Gentamicin, Histrelin implant, Hydrocortisone (enteral), Ipratropium, Levothyroxine, Meloxicam, Mupirocin, Occular lubricant, Omeprazole, Risperidone, Simethicone, Sodium chloride inhalation and Sodium chloride nasal spray. On 17-MAY-2002 the patient was vaccinated with the first dose of VARIVAX (dose/route/frequency unknown). Following the first vaccination the patient presented disseminated rash. On 28-JUL-2014 the patient was vaccinated with the second dose of VARIVAX. On an unknown date in November 2014 the patient experienced prolonged intestinal ileus (first episode) with severe abdominal pain which alleviated with gabapentin and nalbuphine. On 01-FEB-2015 the patient experienced second episode of prolonged ileus. The Polymerase Chain Reaction (PCR) test of the saliva performed on 26-FEB-2015 was positive for VZV. The patient was treated with Valacyclovir (started 3 weeks after symptom onset of February 2015 ileus). The outcome of first occurrence of prolonged intestinal ileus was reported as resolved but the second episode was ongoing at the time of this report. The outcome of disseminated rash is unknown. Reporter's causality was unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Metapneumovirus infection, Parenteral nutrition, Polymerase chain reaction positive, Pyrexia, Rash generalised
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old male patient who was enrolled in a Varicella Zoster Virus (VZV) Identification Program. The patient's concurrent conditions included autism, delayed puberty, Basedow's disease, hydrocephalus, hypothyroidism, Adrenal insufficiency (iatrogenic), juvenile idiopathic arthritis, chronic respiratory disease and chronic kidney disease. The patient was allergic to Beef, Casein, Cashew, Chloral hydrate, COBAN 60, Lactose, Lactulose, Milk, Nuts, Peanut, THORAZINE and Wheat. The patient's medical history included gastrooesophageal reflux disease, Visceral hyperalgesia, premature birth (at 24 weeks gestation) and Oral aversion. Concomitant therapies included Acetaminophen, Albuterol, Baclofen, Budesonide, Cholecalciferol, Citalopram, Diazepam PRN, AQUAPHOR topical ointment, Etanercept, Gentamicin, Histrelin implant, Hydrocortisone (enteral), Ipratropium, Levothyroxine, Meloxicam, Mupirocin, Occular lubricant, Omeprazole, Risperidone, Simethicone, Sodium chloride inhalation and Sodium chloride nasal spray. On 17-MAY-2002 the patient was vaccinated with the first dose of VARIVAX (dose/route/frequency unknown). Following the first vaccination the patient presented disseminated rash. On 28-JUL-2014 the patient was vaccinated with the second dose of VARIVAX. On an unknown date in November 2014 the patient experienced prolonged intestinal ileus (first episode) with severe abdominal pain which alleviated with gabapentin and nalbuphine. On 01-FEB-2015 the patient experienced second episode of prolonged ileus. The Polymerase Chain Reaction (PCR) test of the saliva performed on 26-FEB-2015 was positive for VZV. The patient was treated with Valacyclovir (started 3 weeks after symptom onset of February 2015 ileus). The outcome of first occurrence of prolonged intestinal ileus was reported as resolved but the second episode was ongoing at the time of this report. The outcome of disseminated rash is unknown. Reporter's causality was unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Thyroid function test abnormal, Thyroxine normal, Tri-iodothyronine decreased
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old male patient who was enrolled in a Varicella Zoster Virus (VZV) Identification Program. The patient's concurrent conditions included autism, delayed puberty, Basedow's disease, hydrocephalus, hypothyroidism, Adrenal insufficiency (iatrogenic), juvenile idiopathic arthritis, chronic respiratory disease and chronic kidney disease. The patient was allergic to Beef, Casein, Cashew, Chloral hydrate, COBAN 60, Lactose, Lactulose, Milk, Nuts, Peanut, THORAZINE and Wheat. The patient's medical history included gastrooesophageal reflux disease, Visceral hyperalgesia, premature birth (at 24 weeks gestation) and Oral aversion. Concomitant therapies included Acetaminophen, Albuterol, Baclofen, Budesonide, Cholecalciferol, Citalopram, Diazepam PRN, AQUAPHOR topical ointment, Etanercept, Gentamicin, Histrelin implant, Hydrocortisone (enteral), Ipratropium, Levothyroxine, Meloxicam, Mupirocin, Occular lubricant, Omeprazole, Risperidone, Simethicone, Sodium chloride inhalation and Sodium chloride nasal spray. On 17-MAY-2002 the patient was vaccinated with the first dose of VARIVAX (dose/route/frequency unknown). Following the first vaccination the patient presented disseminated rash. On 28-JUL-2014 the patient was vaccinated with the second dose of VARIVAX. On an unknown date in November 2014 the patient experienced prolonged intestinal ileus (first episode) with severe abdominal pain which alleviated with gabapentin and nalbuphine. On 01-FEB-2015 the patient experienced second episode of prolonged ileus. The Polymerase Chain Reaction (PCR) test of the saliva performed on 26-FEB-2015 was positive for VZV. The patient was treated with Valacyclovir (started 3 weeks after symptom onset of February 2015 ileus). The outcome of first occurrence of prolonged intestinal ileus was reported as resolved but the second episode was ongoing at the time of this report. The outcome of disseminated rash is unknown. Reporter's causality was unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Upper respiratory tract infection, Varicella virus test positive, X-ray abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old male patient who was enrolled in a Varicella Zoster Virus (VZV) Identification Program. The patient's concurrent conditions included autism, delayed puberty, Basedow's disease, hydrocephalus, hypothyroidism, Adrenal insufficiency (iatrogenic), juvenile idiopathic arthritis, chronic respiratory disease and chronic kidney disease. The patient was allergic to Beef, Casein, Cashew, Chloral hydrate, COBAN 60, Lactose, Lactulose, Milk, Nuts, Peanut, THORAZINE and Wheat. The patient's medical history included gastrooesophageal reflux disease, Visceral hyperalgesia, premature birth (at 24 weeks gestation) and Oral aversion. Concomitant therapies included Acetaminophen, Albuterol, Baclofen, Budesonide, Cholecalciferol, Citalopram, Diazepam PRN, AQUAPHOR topical ointment, Etanercept, Gentamicin, Histrelin implant, Hydrocortisone (enteral), Ipratropium, Levothyroxine, Meloxicam, Mupirocin, Occular lubricant, Omeprazole, Risperidone, Simethicone, Sodium chloride inhalation and Sodium chloride nasal spray. On 17-MAY-2002 the patient was vaccinated with the first dose of VARIVAX (dose/route/frequency unknown). Following the first vaccination the patient presented disseminated rash. On 28-JUL-2014 the patient was vaccinated with the second dose of VARIVAX. On an unknown date in November 2014 the patient experienced prolonged intestinal ileus (first episode) with severe abdominal pain which alleviated with gabapentin and nalbuphine. On 01-FEB-2015 the patient experienced second episode of prolonged ileus. The Polymerase Chain Reaction (PCR) test of the saliva performed on 26-FEB-2015 was positive for VZV. The patient was treated with Valacyclovir (started 3 weeks after symptom onset of February 2015 ileus). The outcome of first occurrence of prolonged intestinal ileus was reported as resolved but the second episode was ongoing at the time of this report. The outcome of disseminated rash is unknown. Reporter's causality was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist, via a company representative, refers to a 60 years old female patient. No information on her medical history, concurrent conditions or concomitant drugs was provided. On 20-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX one vial (route and site of administration, dose number, lot # and expiration date not reported). On an unknown date in May 2015, the patient got a rash near the injection site, which hurt and became warm. The outcome of vaccination site rash, vaccination site warmth and vaccination site pain was unknown. The relationship between use of ZOSTAVAX and the adverse events was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous report as received from the company representative who was reported by a health care worker refers to a male patient of unknown age. No demographics were provided for the patient and the physician. No medical history was reported. ON an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX injection. (lot number, dose, strength, frequency and route was not specified). No concomitant medications were reported. On an unknown date, the patient experienced rash at the injection sit4e and torso after receiving (Oka/Merck) VARIVAX. The patient sought for the medical attention and visited the office on unspecified date. The action taken of the suspect drug with respect to event was not reported. The outcome of injection site rash and rash was unknown. The causality was not reported. No product quality complaint (PQC) was filed. The reported events were not considered as cancer. No further adverse event (AE) information was provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. No concurrent condition and historical medication was reported. The patient was vaccinated with two doses of ZOSTAVAX, first dose on 15-DEC-2014 (0.65 ml, subcutaneous) and second dose on 22-MAY-2015 (extra dose administered). No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration
Clinical narrative: Significant reaction (12x7 cm) oval red, indurated reaction to PREVNAR 13 vaccine, properly administered.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: Hives, itching and SOB started within half an hour and progressed.  Pt was sent to ED.
Age: 97.0
Sex: F
Vaccine: PNC13
Symptoms: Rash pruritic, Vaccination site reaction
Clinical narrative: Itchy rash over left deltoid at site of vaccine administration.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, warm and swelling.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Presyncope
Clinical narrative: Patient immediately went into a vasovagal reaction.  EMTs were immediately called, patient transported to Med Facility via Ambulance. Start to finish at our location was approximately 20 minutes.
Age: 3.0
Sex: F
Vaccine: IPV
Symptoms: Abdominal pain, Blood culture, Full blood count, Irritability, Ultrasound abdomen
Clinical narrative: Fussy,? elevated temp and abdominal pain several hours after IPV given.
Age: 79.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Abscess limb, Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, tender, hot to touch.
Age: 79.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Tenderness
Clinical narrative: Red, swollen, tender, hot to touch.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Site was itchy, warm, sore and red.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site was red, itchy and swollen with 48 hours after receiving the vaccine.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Induration, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Left thigh is about 33% more swollen than usual. Circular indurated area is about 10 cm in diameter. Area is warm and mildly tender.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: WITHIN AN HOUR AFTER LEAVING DOCTORS OFFICE MY ARM STARTED SWELLING, WAS RED, ITCHY, PAINFUL, AND WARM TO THE TOUCH. SWELLING CONTINUE TO SPREAD OUT, AND UP AND DOWN THE ARM TO MY SHOULDER AND TO MY ELBOW. I RETURNED TO DOCTORS OFFICE AT 01:00 PM SAME DAY AND THEY PRESCRIBED ME PREDNISONE 10MG AND BACTRIM WHICH I AM STILL TAKING AS OF TODAY. SWELLING HAS GONE DOWN AS OF 5/24/15.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Started out as fever two days prior on May 21st then on 5/23/2015 she woke up with a rash on her head back and chest.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm became red, warm, swollen at site.  Client states that it was very sore (9 out of 10) and she could not lift her arm. Client states that the intense pain lasted for a couple of days.  1 1/2 weeks later client states that the arm is still sore but is better but hurts with constant pressure being applied.  Client states that she saw her doctor about a week after she received the shot.  She states that she was told that 1 in 500 shots given can hit a nerve and if it lasts for awhile longer she may need physical therapy.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Arm became red, warm, swollen at site.  Client states that it was very sore (9 out of 10) and she could not lift her arm. Client states that the intense pain lasted for a couple of days.  1 1/2 weeks later client states that the arm is still sore but is better but hurts with constant pressure being applied.  Client states that she saw her doctor about a week after she received the shot.  She states that she was told that 1 in 500 shots given can hit a nerve and if it lasts for awhile longer she may need physical therapy.
Age: 30.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was administered pediatric dose instead of adult.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: REDNESS, PAIN AND SWOLLEN LEFT ARM.
Age: 42.0
Sex: M
Vaccine: HEP, PNC13
Symptoms: Erythema, Induration, Local reaction, Skin warm
Clinical narrative: LOCAL REACTION. RED, HOT, INDURATION MEASURING ABOUT 2' X 6".
Age: 62.0
Sex: F
Vaccine: MEN, PPV
Symptoms: Cough, Pain
Clinical narrative: DRY COUGH, PAIN.
Age: 54.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Abdominal distension, Abdominal pain, Colonoscopy normal, Dizziness, Dysgraphia
Clinical narrative: 2nd injection mucle cramps in legs/ sick to stomach. Voice became hoarse 3rd shot light headed, abdominal pain kidney pains sick to stomach right hand could not write, muscle cramps, lump in throat. Low grade fever 96.5 stomach bloated last shot stomach got worse left abdominal hurt unable to eat/ problems with digestive, acid reflux.  Lost 30 lbs by end of last shot.  Have been to digestive Dr. Did a colon and stomach scoped test all negative. 1 year later abdominal pain, digestive problems, difficulty digesting foods,  ziphoid area is swollen and become worse with exercise. Muscle cramps in legs, arms, stomach area.  Seeing digestive disease doctor and going back to gastrointestinal Dr.
Age: 54.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Dyspepsia, Dysphonia, Feeding disorder, Gastrooesophageal reflux disease, Muscle spasms
Clinical narrative: 2nd injection mucle cramps in legs/ sick to stomach. Voice became hoarse 3rd shot light headed, abdominal pain kidney pains sick to stomach right hand could not write, muscle cramps, lump in throat. Low grade fever 96.5 stomach bloated last shot stomach got worse left abdominal hurt unable to eat/ problems with digestive, acid reflux.  Lost 30 lbs by end of last shot.  Have been to digestive Dr. Did a colon and stomach scoped test all negative. 1 year later abdominal pain, digestive problems, difficulty digesting foods,  ziphoid area is swollen and become worse with exercise. Muscle cramps in legs, arms, stomach area.  Seeing digestive disease doctor and going back to gastrointestinal Dr.
Age: 54.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Nausea, Pyrexia, Renal pain, Sensation of foreign body, Swelling
Clinical narrative: 2nd injection mucle cramps in legs/ sick to stomach. Voice became hoarse 3rd shot light headed, abdominal pain kidney pains sick to stomach right hand could not write, muscle cramps, lump in throat. Low grade fever 96.5 stomach bloated last shot stomach got worse left abdominal hurt unable to eat/ problems with digestive, acid reflux.  Lost 30 lbs by end of last shot.  Have been to digestive Dr. Did a colon and stomach scoped test all negative. 1 year later abdominal pain, digestive problems, difficulty digesting foods,  ziphoid area is swollen and become worse with exercise. Muscle cramps in legs, arms, stomach area.  Seeing digestive disease doctor and going back to gastrointestinal Dr.
Age: 54.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Weight decreased
Clinical narrative: 2nd injection mucle cramps in legs/ sick to stomach. Voice became hoarse 3rd shot light headed, abdominal pain kidney pains sick to stomach right hand could not write, muscle cramps, lump in throat. Low grade fever 96.5 stomach bloated last shot stomach got worse left abdominal hurt unable to eat/ problems with digestive, acid reflux.  Lost 30 lbs by end of last shot.  Have been to digestive Dr. Did a colon and stomach scoped test all negative. 1 year later abdominal pain, digestive problems, difficulty digesting foods,  ziphoid area is swollen and become worse with exercise. Muscle cramps in legs, arms, stomach area.  Seeing digestive disease doctor and going back to gastrointestinal Dr.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Noticeable hives all over his face.  Injection site red and swollen.  The next day (5/25/15) injection site swelling increased and hives still present.  5/26/15-  Very sore, red, swollen injection site.  Hives still present on his face.  Benadryl administered orally.
Age: 25.0
Sex: F
Vaccine: HPVX
Symptoms: Asthenia, Diarrhoea, Pyrexia, Swelling, Vomiting
Clinical narrative: High fever, vomiting, diarrhea, weak, severe swelling.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Muscular weakness, Nodule, Pain, Weight bearing difficulty
Clinical narrative: Knot in arm bicep; weakness in arm; arm mobility issues, unable to apply weight bearing activities with vaccinated arm; continued pain with movements.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Pyrexia, Rash, Swelling
Clinical narrative: Itching, swelling, fever, rash - treated with Benadryl but didn't completely alleviate. Still has symptoms several days later.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Hypoaesthesia, Laboratory test normal
Clinical narrative: Numbness starting in (L) foot, traveled up to chest, pt can ambulate. Made doc appt all results and labs WNL. Neurologist appt. 6/2/15. Pt has underlying disease state and sees neurologist for MS.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Bedridden, Blood test, Chest discomfort, Fatigue, Hypersomnia
Clinical narrative: This spontaneous report was received from the consumer (patient father) refers to 18 year old female patient. The patient's pertinent medical history included allergy to amoxicillin. On 22-MAY-2014 the patient was vaccinated with GARDASIL first dose, intramuscular in the left arm (dose and frequency were unspecified by the reporter). No concomitant medications were reported. On 22-MAY-2014, after receiving GARDASIL, the patient was tired and slept for the entire day. On an unknown date in May 2014, the patient experienced discomfort in her rib areas, continued to feel lethargic and bedridden (disability). Approximately on an unknown date in 2014 (4-5 days before in June 2014 when she was scheduled to receive her second dose of GARDASIL), the patient collapsed. On an unknown date in May 2014, the patient developed swollen lymph nodes in her pelvic area. On an unknown date, the patient sought medical attention at the physician's office. The patient did not receive any treatment. On an unknown date in May 2014, the patient underwent some blood work. The outcome of the events was reported that the patient was still experiencing the adverse events and has not recovered. The physician did not believe that the events to be related to the suspect therapy, however the patient felt the events to be related to the suspect therapy. The event bedridden was considered serious (disability). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Lethargy, Lymphadenopathy, Syncope
Clinical narrative: This spontaneous report was received from the consumer (patient father) refers to 18 year old female patient. The patient's pertinent medical history included allergy to amoxicillin. On 22-MAY-2014 the patient was vaccinated with GARDASIL first dose, intramuscular in the left arm (dose and frequency were unspecified by the reporter). No concomitant medications were reported. On 22-MAY-2014, after receiving GARDASIL, the patient was tired and slept for the entire day. On an unknown date in May 2014, the patient experienced discomfort in her rib areas, continued to feel lethargic and bedridden (disability). Approximately on an unknown date in 2014 (4-5 days before in June 2014 when she was scheduled to receive her second dose of GARDASIL), the patient collapsed. On an unknown date in May 2014, the patient developed swollen lymph nodes in her pelvic area. On an unknown date, the patient sought medical attention at the physician's office. The patient did not receive any treatment. On an unknown date in May 2014, the patient underwent some blood work. The outcome of the events was reported that the patient was still experiencing the adverse events and has not recovered. The physician did not believe that the events to be related to the suspect therapy, however the patient felt the events to be related to the suspect therapy. The event bedridden was considered serious (disability). Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, IPV, RV5
Symptoms: Wrong drug administered
Clinical narrative: MA gave IPV instead of PCV.
Age: 38.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Hypersensitivity
Clinical narrative: Vaccine given 5/22/15. 5/24/15 pt given Rx BACTRIM secondary to allergic reaction vs. cellulitis. In office 5/26/15 improved symptoms noted. Advised complete BACTRIM, BENADRYL, OTC.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Erythema, Skin warm, Swelling, Vaccination complication
Clinical narrative: Red, warm to touch, raised area started 5.22.15 at 8 pm. Went to urgent care-prescribed AUGMENTIN antibiotic, pt. took for 2 days it went away per mom.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Started itching on way home. Redness has reach approximately 5 inch area (5/20/15). Swelling has reached approximately 8 inch area (5/20/15). MD advised to ice/ibuprofen, will go see MD if worsening. Follow up call 5/26/15-symptoms almost completely subsided.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report has been received from a nurse referring to a female patient of unknown age. No information about pertinent medical history and drug reaction was reported. On an unknown date in April 2015 the patient was vaccinated with the first dose of GARDASIL (dose, frequency, strength, route, lot# and expiration were not reported). No concomitant medication was reported. The patient visited an unspecified physician's office on 18-MAY-2015 and it was determined that the patient was pregnant. It was unknown when the patient became pregnant. No adverse effects were reported. There was no treatment given to the patient. The pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning two unspecified patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. The nurse reported that the patients received the 1st and 2nd doses of the GARDASIL (dose, frequency, route, lot # were not provided) on an unspecified dates. No concomitant therapies were reported. No adverse effect reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a medical assistant r4egarding a 37 year old patient of  unknown gender. No concurrent condition and historical medication was reported. On 19-DEC-2014, the patient was vaccinated with RECOMBIVAX HB injection series, dose 1 and second dose was administered on 18-MAY-2015, outside of the quality complaint was involved. The outcome of event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and unknown gender. Concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On an unspecified dates the patients were vaccinated with exposed to 44F doses of PROQUAD (Merck), (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. No adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, lot #, dose and route unknown). There was no concomitant medication reported. On an unknown date the patient experienced side effects from ZOSTAVAX. She had a large round painful bump with a rash at the vaccine site. She did say it was the size of a silver dollar coin. The outcome of the events was unknown. Additional information has been requested.