chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender, reported as "college age patient". Pertinent medical history, drug reactions or allergies were not reported. On 13-JUN-2014, the patient was vaccinated past its expiry with MMR II lot # H010135, expiry date: 17-MAY-2015, 0.5 ml subcutaneous. The reporter was unsure if it was the patient's first dose. No adverse effects reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous report was received from a physician concerning a female patient of unknown age. Medical history and concurrent conditions were not reported. In 2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiration date and strength were not reported) (dose reported as single standard dose), intramuscular. Co-suspect and concomitant therapies were not reported. On 30-MAY-2014 (reported as about a week ago), the patient developed a fever and chills after vaccination with PNEUMOVAX 23. At the time of the report the outcome was unknown. Patient seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On 10-JUN-2014, the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # 0387AE exp date 31-MAY-2014, 1 ml, intramuscular. Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route, lot number, expiration date and dosage schedule were not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age. The patient was vaccinated with the first, second and third dose of hepatitis B vaccine (manufacturer unknown) (strength, dosage, route unknown) on 20-SEP-2008, 04-DEC-2008, 12-FEB-2009 respectively. The office manager emphasized RECOMBIVAX HB could not be ruled out. No adverse effects reported. Additional information has been requested.
Age: 41.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 41 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 01-APR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J005416; expiration date: 02-MAY-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Puncture site pain
Clinical narrative: This spontaneous report as received from a pharmacist concerning a 52 year old female consumer with high blood pressure, anxiety and gastro esophageal reflux disease (GERD) (reporting on herself). There were no drug reaction allergies. On 18-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX (Lot # J007210, exp date 20-SEP-2014) (0.65 ml dose, intramuscular route, in the upper arm). Concomitant therapies included pain medicines and unspecified anti-depressants. Pharmacist stated that she documented the ZOSTAAVX was administered by the subcutaneous route and was 99% sure ZOSTAVAX was administered by the subcutaneous route. The patient stated to the pharmacist over the phone that ZOSTAVAX was administered intramuscularly. On 18-APR-2014, the patient experienced puncture site pain and redness at the ZOSTAVAX injection site. The patient also described to pharmacist over the phone the location of the site of puncture site pain was reported as not recovered/not resolved. The outcome of redness at the ZOSTAVAX injection site was reported as recovered/resolved. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 25 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 25-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J005416; expiration date: 02-MAY-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 42.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 42 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 24-MAR-2014, the patient was vaccinated with VARIVAX lot #J005416; expiration date: 02-MAY-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (dose, frequency, strength and route were not reported), lot number reported as K003820, expiration date reported as 14-SEP-2015. Co-suspect and concomitant therapies were not reported. The licensed vocational nurse reported that VARIVAX (Merck) were exposed to -14C for 30 minutes and they were administered on an unspecified date to a patient. No adverse effects were reported. These is one (1) of two (2) reports from the same reporter (MARRS 1406USA001137 and 1406USA008023). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of PROQUAD (dose, frequency, strength and route were not reported), lot number reported as K003820, expiration date reported as 14-SEP-2015. Co-suspect and concomitant therapies were not reported. The licensed vocational nurse reported that PROQUAD were expose to -14C for 30 minutes and they were administered on an unspecified date to a patient. No adverse effects were reported. Additional information has been requested. This is one (1) of two (2) reports from the same reporter (MARRS 1406USA001137 and 1406USA008023).
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The physician reported that the patient was administered the first dose of GARDASIL (dose, strength, lot number, expiration date and route were not reported) on 21-MAY-2009; the second dose of GARDASIL (dose, strength, lot number, expiration date and route were not reported) on 29-AUG-2009; and the third dose of GARDASIL on 30-OCT-2009. Co-suspect and concomitant therapies were not reported. No adverse effects reported. Additional information has been requested.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 76 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 24-APR-2014, the patient was vaccinated with ZOSTAVAX lot #J007208; expiration date: 20-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with ZOSTAVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse refers to an unspecified number of patients (no demographics provided). No medical history or concurrent conditions were reported. On an unspecified date, the patients were vaccinated with ROTATEQ (dose, route, strength and lot number were not provided). No co-suspect or concomitant therapies were reported. On an unspecified date, ROTATEQ was administered to an unspecified number of patients after being exposed to 34F for a cumulative time of 18 hours over two excursions, and then to 47F for 9 hours. The reported did not have any patient information. No adverse effects reported. This is one of two reports from the same source. Additional information is not expected.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 65 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 27-MAR-2014, the patient was vaccinated with ZOSTAVAX lot #J007208; expiration date: 20-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with ZOSTAVAX that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via a representative refers to a 60 year old female patient with no pertinent medical history and no drug reactions/allergies. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # J013449, expiration date 24-JAN-2015) (dose and route unspecified). NO concomitant medication was reported. On an unknown date the patient developed "localized injection site reactions, hives 3 inches in diameter, red and raised welts that were itchy and warm to touch, firm and painful". The outcome of "localized injection site reactions, hives 3 inches in diameter, red and raised welts that were itchy and warm to touch, firm and painful" was unknown. The patient sought medical attention via contact pharmacist. This is one of several reports received from same source. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist via a representative refers to a 60 year old female patient with no pertinent medical history and no drug reactions/allergies. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # J013449, expiration date 24-JAN-2015) (dose and route unspecified). NO concomitant medication was reported. On an unknown date the patient developed "localized injection site reactions, hives 3 inches in diameter, red and raised welts that were itchy and warm to touch, firm and painful". The outcome of "localized injection site reactions, hives 3 inches in diameter, red and raised welts that were itchy and warm to touch, firm and painful" was unknown. The patient sought medical attention via contact pharmacist. This is one of several reports received from same source. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via a representative refers to a 62 year old female patient with no pertinent medical history and no drug reactions/allergies. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # J013449, expiration date 24-JAN-2015) (dose and route unspecified). No concomitant medication was reported. On an unknown date the patient developed "localized injection site reactions, hives 3 inches in diameter, red and raised welts that were itchy and warm to touch , firm and painful". The outcome of "localized injection site reactions, hives 3 inches in diameter, red and raised welts that were itchy and warm to touch, firm and painful" was unknown. The patient sought medical attention via contact pharmacist. This is one of several reports received from same source. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist via a representative refers to a 62 year old female patient with no pertinent medical history and no drug reactions/allergies. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # J013449, expiration date 24-JAN-2015) (dose and route unspecified). No concomitant medication was reported. On an unknown date the patient developed "localized injection site reactions, hives 3 inches in diameter, red and raised welts that were itchy and warm to touch , firm and painful". The outcome of "localized injection site reactions, hives 3 inches in diameter, red and raised welts that were itchy and warm to touch, firm and painful" was unknown. The patient sought medical attention via contact pharmacist. This is one of several reports received from same source. Additional information is not expected.
Age: 0.39
Sex: F
Vaccine: HIBV
Symptoms: Convulsion
Clinical narrative: Mother and father report patient had 2 seizures on 5-11-14.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 61 year old female patient who on 10-JUN-2014 was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot # reported as J012678, expiration date 21-JAN-2015). Concomitant therapies included losartan potassium (manufacturer unknown). The pharmacist reported that after the patient received ZOSTAVAX she developed redness and a "swollen lump" at the injection site. The patient called in to the pharmacy on 12-JUN-2014, to report the reaction to the pharmacist. The outcome of redness and swollen lump at the injection site was unknown. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: FLUX, HPV4, UNK, FLU3, HPV4
Symptoms: Accidental exposure to product, Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a 25 year old female pregnant patient. There was no drug reaction/allergies. On 20-MAR-2014 the patient was vaccinated with a dose of GARDASIL (route, lot #, expiration date not reported). Secondary suspect therapies included flu vaccine (manufacturer unknown). Concomitant therapies included a third vaccine (name, manufacturer unknown). The patient received a call from the administered health center to inform the patient that the vaccine was inadvertently administered. "No adverse events are being reported". The patient was pregnant seven months at the time of reporting. The LMP (Last Menstrual Period) was approximately on 09-SEP-2013 and EDD (Estimated Delivery Date) was approximately on 16-JUN-2014. Initial exposure to GARDASIL was at about 27 week(s). The patient's inquiry was what if any were the adverse effects of receiving the GARDASIL while pregnant. No treatment was given. Blood work was performed on 20-MAR-2014 without result provided. The patient didn't seek medical attention. Follow up information has been received from physician. The physician stated that the patient delivered a healthy baby boy by cesarean section (specific reason for cesarean unavailable). There were no complications listed for the patient's pregnancy. The patient had an office visit on 06-JUN-2014 with physician and she is doing right. The physician did not see the baby on that visit. The physician was able to obtain lot numbers for the vaccines. The patient received both GARDASIL and AFLURIA on the same day, 20-MAR-2014. There was no mention of a third vaccine. GARDASIL lot #: J008423, expiration date: 21-JAN-2016. AFLURIA lot # (as reported): 45BL3, expiration date not provided. HIPAA (Health Insurance Portability and Accountability Act) Information was reviewed by the physician. The physician had no other information to share. Upon internal review, cesarean section was considered as medically significant. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLUX, HPV4, UNK, FLU3, HPV4
Symptoms: Caesarean section, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a 25 year old female pregnant patient. There was no drug reaction/allergies. On 20-MAR-2014 the patient was vaccinated with a dose of GARDASIL (route, lot #, expiration date not reported). Secondary suspect therapies included flu vaccine (manufacturer unknown). Concomitant therapies included a third vaccine (name, manufacturer unknown). The patient received a call from the administered health center to inform the patient that the vaccine was inadvertently administered. "No adverse events are being reported". The patient was pregnant seven months at the time of reporting. The LMP (Last Menstrual Period) was approximately on 09-SEP-2013 and EDD (Estimated Delivery Date) was approximately on 16-JUN-2014. Initial exposure to GARDASIL was at about 27 week(s). The patient's inquiry was what if any were the adverse effects of receiving the GARDASIL while pregnant. No treatment was given. Blood work was performed on 20-MAR-2014 without result provided. The patient didn't seek medical attention. Follow up information has been received from physician. The physician stated that the patient delivered a healthy baby boy by cesarean section (specific reason for cesarean unavailable). There were no complications listed for the patient's pregnancy. The patient had an office visit on 06-JUN-2014 with physician and she is doing right. The physician did not see the baby on that visit. The physician was able to obtain lot numbers for the vaccines. The patient received both GARDASIL and AFLURIA on the same day, 20-MAR-2014. There was no mention of a third vaccine. GARDASIL lot #: J008423, expiration date: 21-JAN-2016. AFLURIA lot # (as reported): 45BL3, expiration date not provided. HIPAA (Health Insurance Portability and Accountability Act) Information was reviewed by the physician. The physician had no other information to share. Upon internal review, cesarean section was considered as medically significant. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Anxiety, Discomfort, Headache, Neuralgia, Rash
Clinical narrative: No information regarding concomitant disease, concomitant medications and medical history reported. The patient received an unspecified influenza vaccine in Mar-2014 (with no details reported for manufacturer, brand name, batch, or route of administration). He developed a "bad rash, headache, nerve pain down the back of his neck, anxiety, ringing in the ears. Started feeling uncomfortable second night after vaccine. Ringing in ears started the third night after vaccination. No other medical conditions before this. Will not be having vaccine again. General Practitioner prescribed diazepam for insomnia but I have had no problem sleeping." At the time of reporting, the anxiety, discomfort, ear ringing, nerve pain, rash, and headache were ongoing. The reporter assessed all the reported events to be serious as important medical events.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Tinnitus
Clinical narrative: No information regarding concomitant disease, concomitant medications and medical history reported. The patient received an unspecified influenza vaccine in Mar-2014 (with no details reported for manufacturer, brand name, batch, or route of administration). He developed a "bad rash, headache, nerve pain down the back of his neck, anxiety, ringing in the ears. Started feeling uncomfortable second night after vaccine. Ringing in ears started the third night after vaccination. No other medical conditions before this. Will not be having vaccine again. General Practitioner prescribed diazepam for insomnia but I have had no problem sleeping." At the time of reporting, the anxiety, discomfort, ear ringing, nerve pain, rash, and headache were ongoing. The reporter assessed all the reported events to be serious as important medical events.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Herpes zoster, Injection site swelling, Pyrexia, Rash
Clinical narrative: Arm swelled at injection site. The night it was given (6/13/14) she was unable to sleep on that arm that night. It swelled to grapefruit sized with a pimple head that started to recede Monday 6/16/14. Also had rash and fever. She sent pictures to her Dr. who diagnosed shingles.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Arm swelled at injection site. The night it was given (6/13/14) she was unable to sleep on that arm that night. It swelled to grapefruit sized with a pimple head that started to recede Monday 6/16/14. Also had rash and fever. She sent pictures to her Dr. who diagnosed shingles.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Computerised tomogram abdomen abnormal, Cough, Intestinal malrotation, Intestinal obstruction, Irritability
Clinical narrative: 2 Month old female btought to ER with fever of 101 occurring in AM with associated cough, vomiting, and inability to hold down food. Mother also states that patient has been fussy with excessive salivation and has not been given any Tylenol or Motrin.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Megacolon, Pyrexia, Salivary hypersecretion, Scan with contrast abnormal, Vomiting
Clinical narrative: 2 Month old female btought to ER with fever of 101 occurring in AM with associated cough, vomiting, and inability to hold down food. Mother also states that patient has been fussy with excessive salivation and has not been given any Tylenol or Motrin.
Age: 1.0
Sex: M
Vaccine: MMR, MMRV, PNC13
Symptoms: Blood culture, Full blood count, No adverse event
Clinical narrative: None stated.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Enema administration, Explorative laparotomy, Gastrointestinal necrosis, Haematochezia, Intussusception
Clinical narrative: Presented to urgent care on 5/31/14 with vomiting. Went to ED on 6/1/14 due to persistent vomiting. Had bloody stool in ED so UTZ done, showed intussusception, not reduced by enema. 10cm bowel removed along with Meckel's Diverticulum during exploratory Laparotomy.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Laboratory test abnormal, Pathology test, Small intestinal resection, Ultrasound abdomen abnormal, Vitello-intestinal duct remnant
Clinical narrative: Presented to urgent care on 5/31/14 with vomiting. Went to ED on 6/1/14 due to persistent vomiting. Had bloody stool in ED so UTZ done, showed intussusception, not reduced by enema. 10cm bowel removed along with Meckel's Diverticulum during exploratory Laparotomy.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Presented to urgent care on 5/31/14 with vomiting. Went to ED on 6/1/14 due to persistent vomiting. Had bloody stool in ED so UTZ done, showed intussusception, not reduced by enema. 10cm bowel removed along with Meckel's Diverticulum during exploratory Laparotomy.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Urticaria
Clinical narrative: After injection got 3 welt, called us 6-16-14 told pt to call MD - MD told pt to take BENADRYL and come to office in AM. Pt went to MD - MD said pt got acute shingles break out and prescribed VALTREX.
Age: 35.0
Sex: M
Vaccine: FLUN4
Symptoms: Computerised tomogram thorax abnormal, Erdheim-Chester disease, Hypersensitivity, Pneumonitis
Clinical narrative: A consumer report has been received from the mother of a 35 year old male patient. Medical history and concomitant medication were not reported. The patient received FLUMIST (intranasal) in Nov-2013. A month later, in Dec-2013 he developed inflammation of the lungs. He has been to various doctors. CT scan revealed lung image of ground glass opacity and hypersensitivity. He has been in and out of hospital and is on high dose of prednisone. He was diagnosed with Erdheim-Chester disease. [Erdheim-Chester disease is a rare form of non-Langerhans cell histiocytosis.] At the time of reporting, the inflammation of the lungs was ongoing, and the outcome of Erdheim-Chester disease was unknown. Inflammation of the lungs was reported as a serious event, based on hospitalization. Erdheim Chester disease has been identified by the company physician from the source document and added as an important medical event.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On unspecified dates, improperly stored doses of GARDASIL lot # H020901 expiration date 05-JUL-2015 (strength, dose number, dose, frequency and indication were not reported) was administered. No concomitant medication reported. Outcome and causality was not reported. This is case has been linked to MARRS # 1406USA000382, 1406USA000549, 1406USA000551, 1406USA000552, 1406USA000550, 1406USA008391 and 1406USA008418. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: Pt states she was vaccinated on 6/5/14. "Shortly after" she developed rash under bra line and abdomen. Rash looks like ant bites in clusters and are very itchy.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse midwife refers to an approximately 21 years old female patient with drug reactions/allergies to penicillin. The patient's medical history included had chickenpox before. On 30-MAY-2014, the patient was (9 to 10 weeks pregnant, in her first trimester) vaccinated with a dose of VARIVAX (Merck) injection, dose (unknown), subcutaneously, for given by mistake. Concomitant therapies included Prenatal Vitamin and albuterol sulfate. The patient became pregnant with LMP of March 2014 and EDD of December 2014. The nurse midwife stated the patient was seen in the office on 29-MAY-2014, at which time the patient had a positive pregnancy test performed. Treatment given for adverse event was reported as no. The pregnancy outcome was outcome pending. No Product Quality Complaint (PQC) was involved. The outcome of events was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (Certified Medical Assistant C.M.A.) refers to an unspecified number patients of unknown age and gender. Pertinent medical history and drug reactions or allergies were not specified. On an unknown date, the patients were vaccinated with doses of VARIVAX (Merck), 0.5 ml, subcutaneously, that were improperly stored. The VARIVAX (Merck) was exposed to a highest temperature of 26 Fahrenheit (F) for a total of 24 hours over three different excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (Certified Medical Assistant C.M.A.) refers to an unspecified number patients of unknown age and gender. Pertinent medical history and drug reactions or allergies were not specified. On an unknown date, the patients were vaccinated with doses of PROQUAD (Merck), 0.5 ml, subcutaneously, that were improperly stored. Concomitant medications were not specified. The PROQUAD (Merck) was exposed to a highest temperature of 26 Fahrenheit (F) for a total of 24 hours over three different excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse. The nurse reported on unknown date, multiple unspecified patients were administered RECOMBIVAX HB that were stored improperly. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse. The nurse reported on unknown date multiple unspecified patients were administered M-M-R II that were stored improperly. No adverse effects reported. This is one of several report received from same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report as received from a physician via a nurse (also reported with degree certified medical assistant, C.M.A.) refers to a 26 years old female patient with no drug reactions or allergies and no pertinent medical history. On 11-APR-2011, the patient was vaccinated with first dose of GARDASIL (120Y, dose and Lot# not reported), on 15-JUN-2011 with the second dose  and on 12-DEC-2011 with the third dose of GARDASIL (dose and Lot# not reported). Concomitant therapies included YAZ. In an approximately June 2014, reported as now (contact date: 11-JUN-2014), the patient was testing with reflex hybrid capture DNA Pap smear and was positive for HPV types 16 and 18 and her situation was classified as high risk. The patient sought medical attention by visiting the office. No treatment was given for adverse event. The patient's outcome was reported as not recovered. Causality assessment between testing positive for HPV types 16 and 18 and GARDASIL was not provided. Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an approximately 68 years old patient of unknown gender. On 09-JUN-2014 the patient was vaccinated with ZOSTAVAX. On 09-JUN-2014 medication error reported that the patient received improperly stored ZOSTAVAX exposed to 7F (Fahrenheit) for an undetermined timeframe. No adverse effect reported. There was no product quality complaint involved. The outcome of the medication error was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history was unknown. On 16-JUL-2013 the patient was vaccinated with first dose of ZOSTAVAX vial (strength, dose unit, lot number and expiry date, route unknown). No concomitant medication were reported. Patient received two doses of ZOSTAVAX. On 13-JUN-2014 the patient was vaccinated with second dose of ZOSTAVAX (strength, dose unit, lot number and expiry date, route unknown) and no adverse effect was reported. The outcome of patient had received two doses of ZOSTAVAX and no adverse effect was unknown. No further information was provided. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old patient of unknown gender. Concurrent conditions and medical history were not provided. On 30-MAY-2014, the patient ws vaccinated with M-M-R II (lot # 0644AE, expiration date 27-MAR-2014) (dose, dose number and route were not provided). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified multiple patients of unknown gender and unknown age. On an unknown date, the unspecified multiple patients were vaccinated with doses of PROQUAD (lot/batch number, expiration date, dose, route and indication not reported) that were improperly stored. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age and gender. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested,
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a other health professional referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with expired dose of ZOSTAVAX vial, subcutaneous (strength and dose not reported). No other concomitant therapies reported. No adverse effect reported. The healthcare worker declined to provide any further information. The outcome of the event was unknown. The causality of the event was unspecified. No PQC reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (Merck) injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: This spontaneous report was received from a physician referring to unspecified number of patients. On an unknown date the patients were vaccinated with ZOSTAVAX, subcutaneous (strength and dose not reported). No other concomitant therapies reported. On an unknown date unspecified number of patients reported to the physician, receiving post herpetic neuralgia after receiving ZOSTAVAX. Physician does not request a VZVIP packet to be sent. No PQC reported. The outcome of post herpetic neuralgia was unknown. The causality of the events was unspecified. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Wrong technique in drug usage process
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No relevant medical history of the patient was reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose number, dose, route of administration, lot number and expiration dates were not reported). No concomitant medications were reported. It was reported that the pharmacist had been using a 31 gauge insulin needle to administer ZOSTAVAX. On an unknown date the patient experienced tenderness and redness at injection site. The patient had sought medical attention by contacting the pharmacist. There was no product quality complaint involved. The outcome of tenderness and redness at injection site was unknown. The causality was unknown. It was reported that the pharmacist could not provide any information on how many patients received ZOSTAVAX with insulin need of 31 gauge. This case is linked to the case # 1406USA008277 via the same reporter link. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 60 year old female patient with no drug reactions or allergies. On 23-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot# and dose not reported). Concomitant medication included an unspecified blood pressure medication (dose and frequency unspecified). On 30-MAY-2014, the patient was experiencing the shingles virus after receiving ZOSTAVAX. No treatment was given for the event. No lab diagnostics studies was performed. The patient sought medical attention by visiting to the office. At the time of report, the outcome of the event was reported as not recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: This spontaneous report as received from a health care worker refers to a approximately 70 year old female patient with no drug allergies. The patient's medical history was none. On 20-MAY-2014 the patient was vaccinated with ZOSTAVAX. Concomitant medications were none. On an unknown date in May 2014 the patient experienced itching and swelling. Lab diagnostic tests performed were none. The patient sought treatment at an unspecified immediate care center prior to 28-MAY-2014 and treatment medications were unspecified. The outcome of itching and swelling was reported as recovered with no continuing issues. The causality of itching and swelling was not reported. This case is linked to 1406USA004741 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 month old patient, unspecified gender. On 28-MAY-2014, the patient was inadvertently administered 0.5ml dose of VARIVAX (Merck) subcutaneous (lot# and expiration date were unspecified) and 0.5ml dose of PROQUAD (Merck) (route of administration, lot# and expiration date were unspecified). No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified multiple patients of unknown gender and unknown age. On an unknown date, the unspecified multiple patients were vaccinated with doses of VARIVAX (Merck) (lot/batch number, expiration date, dose, route and indication not reported) that were improperly stored. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular, Varicella
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history was not provided. On an approximately 12-MAY-2014 (reported as "about three weeks ago"), the patient received their first dose of VARIVAX (Merck) (dose, route of administration, lot# and expiration date were unspecified). No concomitant medication was provided. The physician stated that the patient was healthy. On an unspecified date in 2014 after the dose, the patient developed a varicella like rash "which was confirmed to be vaccine related chickenpox". The reporter stated that he was not the treating physician, and did not know the name of treating physician or any patient information. The outcome of chickenpox was unknown. The reporter considered the chickenpox to be related to VARIVAX (Merck). The patient sought medical attention. Additional information has been requested.