chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Induration, Injection site pain, Lymphadenopathy, Oedema peripheral, Tenderness
Clinical narrative: This spontaneous report as received from a physician refers to an 11-year-old male patient. The patient had no drug reactions/allergies. On 23-JUN-2014, the patient was vaccinated with GARDASIL (lot # J009788, expiration date 17-MAR-2016), 0.5 ml, intramuscular. Concomitant therapies included VYVANSE. On 30-JUN-2014 (2 days ago), the patient developed lymph node swelling under his arm (left axilla) after receiving GARDASIL dose on 23-JUN-2014. Patient came in to the office on 02-JUL-2014 for swelling under the armpit and pain around injection site. Physician reported that swollen area was not infected but it was hardened and tender. No treatment was given for adverse events and no lab diagnosis studies were performed. The outcomes of the events were reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular, Varicella virus test negative
Clinical narrative: This spontaneous report as received from a physician (also reported as healthcare worker) refers to 2 patients of unknown age and gender (all reported as not pregnant). On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX (lot#, strength, dose, frequency and route unspecified). Eighteen days later (exactly date unknown) they developed mild varicella like rashes. He stated that samples of the rashes were sent to the Centers for Disease Control and Prevention (CDC) and it was determined the strain of varicella "was not wild type". He stated that the patients were treated with ACYCLOVIR and "topicals". The outcome of the event was reported as recovering. He stated that at the time of the call he did not have any patient specific information available. Additional information is not expected as the physician did not want to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an health care worker refers to an unspecified number of patients of unknown age and gender might have received ROTATEQ (lot# unspecified) dose, frequency and location unspecified, which were stored improperly on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
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 63 year old patient. On 18-JUN-2014, the patient was vaccinated with first dose of VAQTA (dose, route, and lot # unknown), concomitantly with hepatitis B vaccine (manufacturer unspecified). On 18-JUL-2014 the patient was inadvertently vaccinated with second dose of VAQTA 1 ml, (lot #J010653 expiry date 02-AUG-2015), intramuscularly. No adverse effects reported. Additional information has been requested.
Age: 4.0
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 a 4 year old male patient of unknown gender. On 15-JUL-2014, a 0.5 ml of (Oka/Merck) VARIVAX (lot # unspecified) subcutaneous, (frequency and location unspecified) which was underwent a temperature excursion was administered to the patient. No adverse effect reported. At the time of report, the outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inflammation, Pain, Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to seven patients of unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX23 (lot #, strength, dosage and route unknown). On 02-JUL-2014 the patients experienced a large painful, inflamed, reddish, patchy rash after receiving PNEUMOVAX23. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender might have received PNEUMOVAX23 (lot # unspecified) dose, frequency and location unspecified, which were stored improperly on an unspecified date. No adverse effects 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 Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. In July 2014, between 08-JUL-2014 and 11-JUL-2014, an unspecified number of patients were vaccinated with an improperly stored PROQUAD (merck) (strength, route, lot number and expiration date not reported). No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an healthcare worker refers to an unspecified number of patients of unknown age and gender might have received VAQTA (lot # unspecified) dose, frequency and location unspecified, which were stored improperly on an unspecified date. No adverse effects reported. This is one of several reports received from the same source. 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 an health care worker refers to an unspecified number of patients of unknown age and gender might have received RECOMBIVAX HB (lot # unspecified) dose, frequency and location unspecified, which were stored improperly on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 19-JUL-2014, the patient was vaccinated with the first dose of PNEUMOVAX23 lot # H021941, expiration date 11-JUL-2011, 0.5 ml, intramuscular. No co-suspect and concomitant therapies were reported. The pharmacist stated that patient inadvertently received expired dose of PNEUMOVAX23 on 19-JUL-2014. No adverse effects reported. Patient did not seek medical attention. 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 refers to a patient of unknown age and gender. On 10-JUN-2014 the patient was vaccinated with RECOMBIVAX HB (dose and lot # not reported) which was improperly stored, intramuscularly. The patient received an intramuscular dose in accordance with the prescribing information. No adverse events were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. Medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX vial, 1 subcutaneous injection, lot number, expiration date and dosage were not reported. Concomitant therapy was not reported. The nurse practitioner informed that on an unknown date the patient presented with shingles two weeks after being administered ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from the patient's friend refers to her friend a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. On an unknown date the patient was diagnosed with shingles after receiving ZOSTAVAX. The outcome of the event was unknown.  Additional information is not expected due to no contact details were provided.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via a company representative concerning a 51 year old female patient. Medical  history and concurrent conditions were not reported. On 12-JUL-2014, the patient was vaccinated with ZOSTAVAX dose reported as 1 single shot, subcutaneous (strength and lot number were not reported). Secondary and concomitant therapies were not reported. The physician reported on 12-JUL-2014, after receiving ZOSTAVAX the anonymous patient developed a red line from the injection site to the elbow that was raised and sensitive to touch.  The outcome of the events were reported as recovering. The treatment given for the adverse event was ibuprofen and cold compress. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer reports three patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, route and indication was not reported). On an unknown date, the patients experienced shingles. At the time of the report the outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer reports a children of unknown age and gender. On an unknown date, the patient ws vaccinated with ZOSTAVAX (dose, route and indication was not reported). On an unknown date, the patient experienced shingles. At the time of the report the outcome was unknown. This is one of several reports from the same source.  Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 43 year old male patient. On 21-JUL-2014 the patient was inadvertently vaccinated with PROQUAD (merck) (dose, route and lot # were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a physician via Pfizer Sales Representative. A patient of unknown age and gender received PREVNAR 13 in Jul2014 at single dose. Relevant medical history and concomitant medications were unknown. After vaccination, on an unknown date in Jul2014, the patient had immediate redness and swelling at the injection site and developed cellulitis. Relevant laboratory data was unknown. Therapeutic measure taken in response to the reported events was not provided. Clinical outcome of the reported events was unknown at the time of report. Physician mentioned that the adverse events were due to PREVNAR 13.
Sex: F
Vaccine: MMR
Symptoms: Antibody test abnormal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient ws vaccinated with M-M-R II (lot, dose and route not reported). Concomitant medication was not reported. On 22-JUL-2014, the patient called into the pharmacy stating she had "low titers" after receiving M-M-R II. The outcome of the event was unknown. Additional information is not expected.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt. stated that the day after vaccination he had redness and swelling at injection site. The next day (7/18), redness and swelling increased with warmth, and heat in the injection site, and pain in joint. Doctor recommended BENADRYL and ice.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site joint pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt. stated that the day after vaccination he had redness and swelling at injection site. The next day (7/18), redness and swelling increased with warmth, and heat in the injection site, and pain in joint. Doctor recommended BENADRYL and ice.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. stated that the day after vaccination he had redness and swelling at injection site. The next day (7/18), redness and swelling increased with warmth, and heat in the injection site, and pain in joint. Doctor recommended BENADRYL and ice.
Age: 1.58
Sex: M
Vaccine: DTP, HIBV, DTAP, HIBV
Symptoms: Ear swelling, Erythema, Eyelid oedema, Rash erythematous, Urticaria
Clinical narrative: Had a red rash/hives around diaper area, neck, swollen red ears around two hours after DPT and Hib vaccine administration. Rash tapered on its own by 5 p.m. Patient slept through the night, woke up with rash on torso, armpits and back, and had swollen eye lids. Have Benadryl orally (4 ml) at 7:30 a.m. 7/24/14. Symptoms dissipated by 8:30 a.m.
Age: 1.58
Sex: M
Vaccine: DTP, HIBV, DTAP, HIBV
Symptoms: Dermatitis contact, Rash, Urticaria
Clinical narrative: Had a red rash/hives around diaper area, neck, swollen red ears around two hours after DPT and Hib vaccine administration. Rash tapered on its own by 5 p.m. Patient slept through the night, woke up with rash on torso, armpits and back, and had swollen eye lids. Have Benadryl orally (4 ml) at 7:30 a.m. 7/24/14. Symptoms dissipated by 8:30 a.m.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified dates in approximately 2014 (also reported as since May 2014), an unspecified number of patients were administered GARDASIL (dose, route of administration, lot # and expiration date were not provided) that tell to a temperature of 33F. This excursion was supported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a patient of unknown age and gender. No information received regarding medical history and concurrent conditions. On an unknown date the unspecified patients were vaccinated with liquid PEDVAXHIB (dose, lot#, not reported. No concomitant medications reported. The nurse reported that since 01-JUL-2014, unspecified patients may have been administered with liquid PEDVAXHIB, that were not stored properly. No adverse effects reported. This is one of the several report received from the same reporter.   Follow up information has been received. On 23-JUL-2014, a phone call was placed to Licensed practitioner nurse. The office admin answered the phone call.  A message was left with the admin requesting that the L.P.N, return the phone call. Additionally, a request was made for patients identifiers, lot numbers and expiration date and dates of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified dates in approximately 2014 (also reported as since May 2014), an unspecified number of patients were administered VAQTA (dose, route of administration, lot # and expiration date were not provided) that fell to temperature of 33F. This excursion was supported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified dates in approximately 2014 (also reported as since May 2014), an unspecified number of patients were administered PNEUMOVAX23 (dose, route of administration, lot# and expiration date were not provided) that fell to a temperature of 33F. This excursion was supported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Borrelia test, Facial pain, Facial paresis, VIIth nerve paralysis
Clinical narrative: Days after recieving the 1st anthrax vaccine, pt reports right facial weakness. 3/25/2014 seen by doctor. Doctor's note states that pt has slight pain over v3 section of face and slight tearing of eye. Pt reports to Imms nurse today that Bell's Palsy lasted 2 months.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling (4 inch X 3 inch area) at injection site; warm to the touch; no complaints of pain.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Presyncope
Clinical narrative: Vasovagal - near syncope. Responded with rest for another 15-25 minutes - released good condition.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified dates in approximately 2014 (also reported as since May 2014), an unspecified number of patients were administered RECOMBIVAX HB (dose, route of administration, lot# and expiration date were not provided) that fell to a temperature of 33F. This excursion was supported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: This spontaneous report as received from a physician via Company Representative refers to a 11 year old male patient. On 11-JUL-2014, the patient was vaccinated with GARDASIL, intramuscular (dose, dose number and lot# not reported) and VAQTA (dose, lot# and route not reported). Concomitant therapies included meningococcal vaccine (unspecified). It was unknown which dose of GARDASIL the patient received and if he had completed the series. On 12-JUL-2014, the day after vaccination, the patient experienced sore throat and fever of 103 degrees Fahrenheit. On 14-JUL-2014, the patient went in for an office visit and was given ALEEVE for his symptoms. The patient's temperature went down to 98.4 degrees Fahrenheit on 14-JUL-2014. The outcome for sore throat was unknown. Relatedness between sore throat and fever of 103 degrees Fahrenheit and vaccination with GARDASIL and VAQTA was not 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 nurse refers to 10 patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. Post 16-JUL-2014, date unspecified, 10 patients were vaccinated with VARIVAX (lot K002046, expiration date 10-FEB-2016, injection, 0.5 ml) subcutaneously. The nurse reported that there were two times temperature excursions affecting these VARIVAX products. The first excursion was on 16-JUL-2014 and was supported. The second excursion was on 21-JUL-2014 and was also supported. No adverse effects was noted/reported by any patient. Patients did not seek for medical attention. No product quality complaint (PQC) involved. This is one of several reports received from the same source.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Bronchospasm
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 17 year old female patient. On 23-JUN-2014 the patient was vaccinated with the first dose of GARDASIL, intramuscular (dose, lot# not reported). On 23-JUN-2014, the patient experienced bronchospastic response after being administered with the injection (first injection of a three dose series) of GARDASIL. The outcome of bronchospastic response was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a clinical manager refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with M-M-R II (HSA) lot # J002502, expiration date: 28-FEB-2015, dose and route not reported. No concomitant medication reported. The reporter reported that M-M-R II (HSA), reached temperatures that were outside the prescribing information (also reported as M-M-R II) was not stored at 11 degree Celsius it was stored at -11 degrees Celsius). Outcome and causality was not reported. This case has been linked to 1407USA006606, 1407USA008586, 1407USA008584, and 1407USA008585. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified dates in approximately 2014 (also reported as since 2014), an unspecified number of patients were administered ROTATEQ, oral (dose, lot # and expiration date were not provided) that fell to a temperature of 33F. This excursion was supported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age. On an unknown dates the patients were vaccinated with improperly stored GARDASIL (dose, frequency, route and lot# not reported). No adverse effects. Additional information has been requested.
Age: 0.54
Sex: F
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (lot #J010966, expiration date 20-MAR-2015 and lot # J010140 expiration 26-APR-2015). Strength, dose and route were not provided. ROTATEQ was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported.  Follow up information has been received from the registered nurse and reported that ROTATEQ stability cut off date was 02-MAY-2014. The registered nurse stated that anyone who was vaccinated with vaccine after these dates needed to be contacted for re-vaccination. The registered nurse refused to share patient identifiers on these patients, per Health Insurance Portability and Accountability Act (HIPPA).  HIPPA was reviewed with the nurse and she stated she would need to get that information from her supervisor. The phone call was transferred to her Supervisor.   The follow up information provided the primary reporter's occupation as a medical assistant. She reported that 3 unspecified patients were vaccinated with the improperly stored ROTATEQ. This case refers to 2 unspecified patients vaccinated with the third dose of ROTATEQ. There was one patient vaccinated with dose number 2 (case#1406USA00050). All patient received the vaccine on 02-MAY-2014. Lot # and expiration date for all patients vaccinated with ROTATEQ was J010966, 20-MAR-2015 (previously it was reported that also lot# J010140 with expiration date 26-APR-2015 was used).   Follow up was received from medical assistant regarding 6 months old (also reported as 8 months) female patient. On 02-MAY-2014 at 10:01 the patient was vaccinated orally with the third dose of ROTATEQ lot number J010966 expiration date 20-MAR-2015. Concomitant therapies included PREVNAR13, MRC-15, and PENTACEL. There were none adverse events reported.  This is one of several reports received from the same reporter. 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 nurse refers to 7 patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. After 16-JUL-2014, date unspecified, 7 patients were vaccinated with VARIVAX (lot #K002922, expiration date 26-FEB-2016, injection, 0.5ml) subcutaneously. The nurse reported that there were two times temperature affecting VARIVAX. The first excursion was on 16-JUL-2014 and was supported. The second excursion was on 21-JUL-2014 and was also supported. No adverse effects was noted/reported by any patient. Patients did not seek medical attention. No product quality complaint (PQC) involved.  This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: This spontaneous report as received from a nurse via Company Representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot # not provided). On an unknown date the patient developed tinnitus after receiving ZOSTAVAX. The outcome of tinnitus was unknown. Relatedness between the event and ZOSTAVAX was not specified. Additional information has been requested.
Age: 0.44
Sex: M
Vaccine: RV1
Symptoms: No adverse event
Clinical narrative: No adverse signs or symptoms.
Age: 0.38
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever to 102, urticarial rash.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unknown number of patients. The patients demographics were unknown. There was  not pertinent medical history and drug reaction or allergies of the patients reported. The reporter stated on an unknown date several clients were vaccinated with PNEUMOVAX23 (dose, route, product lot and expiry date was not reported) that had been improperly stored. No adverse effect reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse who refers to a 5 year old patient of unknown gender. On 21-MAY-2014, the vaccine M-M-R II was expose to 50.5 F for 1 hour. On 27-MAY-2014, the patient was vaccinated with M-M-R II 0.5 ml, subcutaneous, dose 2, (lot # H017430; expiration date: 20-SEP-2014) that was exposed to 50.5 F for 1 hour. No adverse effects reported. At the time of the report the action taken was not reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unknown number of patients. The patients demographics were unknown. There was no pertinent medical history and drug reaction or allergies of the patients reported. On an unknown date since APR-2014, an unknown number of patients was vaccinated with GARDASIL (dose, route, product lot and expiry date was not reported) that had been improperly stored. No adverse effects reported. The reporter stated that M-M-R II was not improperly stored. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On 14-JUL-2014 the patient was vaccinated with expired VARIVAX (injection, lot # J006359, expiration date 23-MAY-2015 (original), dose and route were not provided). The nurse reported that the VARIVAX had a previously reported temperature excursion (details not known or provided) and the nurse was told to change the expiration of the product to 12-JUL-2014 as a result of the in-house temperature stability evaluation. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ROTATEQ, oral (dose, lot # not reported) that was improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Exposure via direct contact, Injection site extravasation, Underdose, Wrong technique in drug usage process
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date in July 2014 the patient was vaccinated with MMR II (subcutaneous, dose, units, route of administration, anatomical location, lot number were not reported). The reporter stated that a patient received less than a full dose of MMR II due to poor administration technique on the part of the administering nurse on an unspecified ate within the last week (in July 2014). The reporter also stated that some of the MMR II leaked out the administration site and leaked onto patient's skin. No other adverse effects reported. Additional information is not expected because the reporter did not wish to be contacted.
Sex: U
Vaccine: MMRV
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. On 07-JUL-2014 the patient was vaccinated with expired dose of PROQUAD (Merck) lot#H020854, expiration date: 26-MAY-2014 (dose not reported). No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a healthcare worker via field representative refers to a patient of unknown age. No information about medical history, drug reactions and allergies was specified. The healthcare worker stated that recently on unspecified dates, four unspecified patients were administered PNEUMOVAX 23 injection (lot#, dose, route, not reported). No concomitant medications were reported. According to the healthcare worker the four patients experienced high fevers after the administration of the PNEUMOVAX on unspecified dates. There was no product quality complaint. The outcome of high fever is unknown. The causality of the event was not specified by the reporter. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: H5N1
Symptoms: Bradycardia, Cardiovascular evaluation, Cataplexy, Fall, Hypnagogic hallucination
Clinical narrative: Initial report received from Literature on 17 July 2014. The following verbatim obtained from article abstract: Report of case: A 31-year-old physician presented with progressive daytime sleepiness 2-3 months after receiving an adjuvanted H5N1 Influenza vaccine in a clinical trial. When his sleepiness began, he had episodes of syncope and falls without loss of consciousness, one resulting in a wrist fracture. Cardiac evaluation revealed asymptomatic bradycardia and high vagal tone. Despite trials of Methylxanthine therapy, his symptoms progressed. Over the following year, his weight increased 21 kg but was subsequently improved with intensive exercise. He reported variable sleep latency and 8-9 hours of total sleep time. He had frequent sleep attacks that resolved with napping, nightly hypnagogic hallucinations and episodes of sleep paralysis. His wife denied snoring, apneas or abnormal movements. Exam revealed a heart rate of 50, normal oxygen saturation, body mass index of 23 kg/square meter and class 1 Mallampati score. His initial Epworth sleepiness scale score was 21. Overnight polysomnogram showed a sleep latency of 10.5 minutes, 92% sleep efficiency, REM latency of 145 minutes with 4 discrete REM periods, with no evidence of sleep disordered breathing or movement disorder. Multiple sleep latency testing revealed a mean sleep latency of 8 minutes with 2 sleep-onset REM periods. He was diagnosed with narcolepsy and modafinil was initiated. After 12 weeks of therapy, daytime sleepiness was improved; however, the patient had worsening hypnagogic hallucinations, sleep paralysis and cataplexy without syncope. Sodium oxybate was added to modafinil. Conclusion: Beginning in 2010, there has been an increased incidence of narcolepsy in patients receiving an adjuvanted H1N1 influenza vaccine. In November 2013, the FDA approved the first adjuvanted influenza vaccine (H5N1) for use. This is the first reported case or narcolepsy following administration of an adjuvanted H5N1 influenza vaccine. Documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: H5N1
Symptoms: Narcolepsy, Sleep attacks, Sleep paralysis, Sleep study, Somnolence
Clinical narrative: Initial report received from Literature on 17 July 2014. The following verbatim obtained from article abstract: Report of case: A 31-year-old physician presented with progressive daytime sleepiness 2-3 months after receiving an adjuvanted H5N1 Influenza vaccine in a clinical trial. When his sleepiness began, he had episodes of syncope and falls without loss of consciousness, one resulting in a wrist fracture. Cardiac evaluation revealed asymptomatic bradycardia and high vagal tone. Despite trials of Methylxanthine therapy, his symptoms progressed. Over the following year, his weight increased 21 kg but was subsequently improved with intensive exercise. He reported variable sleep latency and 8-9 hours of total sleep time. He had frequent sleep attacks that resolved with napping, nightly hypnagogic hallucinations and episodes of sleep paralysis. His wife denied snoring, apneas or abnormal movements. Exam revealed a heart rate of 50, normal oxygen saturation, body mass index of 23 kg/square meter and class 1 Mallampati score. His initial Epworth sleepiness scale score was 21. Overnight polysomnogram showed a sleep latency of 10.5 minutes, 92% sleep efficiency, REM latency of 145 minutes with 4 discrete REM periods, with no evidence of sleep disordered breathing or movement disorder. Multiple sleep latency testing revealed a mean sleep latency of 8 minutes with 2 sleep-onset REM periods. He was diagnosed with narcolepsy and modafinil was initiated. After 12 weeks of therapy, daytime sleepiness was improved; however, the patient had worsening hypnagogic hallucinations, sleep paralysis and cataplexy without syncope. Sodium oxybate was added to modafinil. Conclusion: Beginning in 2010, there has been an increased incidence of narcolepsy in patients receiving an adjuvanted H1N1 influenza vaccine. In November 2013, the FDA approved the first adjuvanted influenza vaccine (H5N1) for use. This is the first reported case or narcolepsy following administration of an adjuvanted H5N1 influenza vaccine. Documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: H5N1
Symptoms: Syncope, Weight increased, Wrist fracture
Clinical narrative: Initial report received from Literature on 17 July 2014. The following verbatim obtained from article abstract: Report of case: A 31-year-old physician presented with progressive daytime sleepiness 2-3 months after receiving an adjuvanted H5N1 Influenza vaccine in a clinical trial. When his sleepiness began, he had episodes of syncope and falls without loss of consciousness, one resulting in a wrist fracture. Cardiac evaluation revealed asymptomatic bradycardia and high vagal tone. Despite trials of Methylxanthine therapy, his symptoms progressed. Over the following year, his weight increased 21 kg but was subsequently improved with intensive exercise. He reported variable sleep latency and 8-9 hours of total sleep time. He had frequent sleep attacks that resolved with napping, nightly hypnagogic hallucinations and episodes of sleep paralysis. His wife denied snoring, apneas or abnormal movements. Exam revealed a heart rate of 50, normal oxygen saturation, body mass index of 23 kg/square meter and class 1 Mallampati score. His initial Epworth sleepiness scale score was 21. Overnight polysomnogram showed a sleep latency of 10.5 minutes, 92% sleep efficiency, REM latency of 145 minutes with 4 discrete REM periods, with no evidence of sleep disordered breathing or movement disorder. Multiple sleep latency testing revealed a mean sleep latency of 8 minutes with 2 sleep-onset REM periods. He was diagnosed with narcolepsy and modafinil was initiated. After 12 weeks of therapy, daytime sleepiness was improved; however, the patient had worsening hypnagogic hallucinations, sleep paralysis and cataplexy without syncope. Sodium oxybate was added to modafinil. Conclusion: Beginning in 2010, there has been an increased incidence of narcolepsy in patients receiving an adjuvanted H1N1 influenza vaccine. In November 2013, the FDA approved the first adjuvanted influenza vaccine (H5N1) for use. This is the first reported case or narcolepsy following administration of an adjuvanted H5N1 influenza vaccine. Documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Fall, Incontinence, Unresponsive to stimuli
Clinical narrative: Ct. slid out of chair and was unresponsive for approx. 10 sec., ct. incontinent.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site rash, Rash papular
Clinical narrative: Pt has erythematous papular rash at site of varicella vaccine administration to anterior right thigh. No vesicular lesions appreciated when pt presented to office 7/21/14 and was evaluated by physician.
Age: 1.18
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Seizure, febrile, simple.
Age: 49.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Mass
Clinical narrative: Low fever, red swollen painful arm at injection site, nausea, unable to lift arm laterally from body without extreme pain. Hives on neck and middle torso started 7/23, and 7/24, knotted lump with extreme itching at injection site.
Age: 49.0
Sex: F
Vaccine: DTAP
Symptoms: Mobility decreased, Nausea, Pyrexia, Urticaria
Clinical narrative: Low fever, red swollen painful arm at injection site, nausea, unable to lift arm laterally from body without extreme pain. Hives on neck and middle torso started 7/23, and 7/24, knotted lump with extreme itching at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Hypersensitivity, Rash generalised, Rash vesicular, Vaccination complication
Clinical narrative: Father of client calls stating that his son is broke out in a rash covering his entire body that looks similar to chickenpox.  Advised to take client to see his pediatrician.  Client returns call and states that pediatrician indicated that rash was an allergic reaction to vaccines administered 1 week ago and prescribed Benadryl.
Sex: F
Vaccine: HEPA
Symptoms: Myelitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 54 years old female patient. There was no pertinent medical history, drug reactions or allergies reported. On an unknown date (reported as a number of years ago) the patient was vaccinated with Hepatitis A vaccine, (Manufacturer unknown) (strength, route, lot number and expiration date not reported) for employment reasons. On an unknown date, after receiving the vaccine, the patient was hospitalized with Myelitis. At the time of the report the outcome of myelitis was reported as recovered, reported as patient was Okay. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified "13-14" year old male patient. On an unknown date the patient received the second dose of VARIVAX (Merck) (route, dosage and lot number unknown). First dose was received on an unknown date. It was reported that the patient had "negative titers" for varicella after receiving 2 doses of VARIVAX (Merck) on unspecified dates. Additional information is not expected because there is no permission to contact physician.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient. The reporter stated that patient received expired dose of PROQUAD (dose 2 in series) (0.5 ml, subcutaneously) (dose 2 in series). The reporter stated PROQUAD had expiry of 08-JUL-2014 and was administered on 21-JUL-2014. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 02-JUL-2013, the patient was vaccinated with first dose of GARDASIL (dose, route of administration, anatomical location, lot #: not provided). On 08-JUL-2014, the patient was vaccinated with the second dose of GARDASIL (dose, route of administration, anatomical location, lot #: not provided). No adverse effects were reported. Additional information is not expected, as the reporter refused additional contact.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 5 year old patient of unknown gender. On 21-MAY-2014, the vaccine M-M-R II was exposed to 50.5 F for 1 hour. On 16-JUN-2014, the patient was vaccinated with M-M-R II 0.5 ml subcutaneous, dose 2, (lot # H017430; expiration date: 20-SEP-2014) that was exposed to 50.5 F for 1 hour. No adverse effects reported. At the time of the report the action taken was no reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and sex. The patient's medical history and current condition are not reported. It was reported that GARDASIL (Lot # and expiry date not reported) injection 120 Y of normal dose and normal route was administered on 10-APR-2014, 27-MAY-2014 and 22-JUL-2014. No adverse effects were noted. The outcome of the event is unknown. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 51 year old male patient without drug reactions and allergies. The patient's medical history included unspecified nasal surgery. On 30-MAY-2013 the patient was vaccinated with PNEUMOVAX23 dose 1, intramuscular (lot # was not reported). There were not concomitant medications. On 13-JUN-2014 (also reported as 2 weeks after administration of the PNEUMOVAX23), the patient had titers drawn. He only had "4 markers", rather than 23. Because of this, the patient's physician wanted the patient to have a "booster" dose of PNEUMOVAX23, six weeks after receipt of dose 1. A second dose of the PNEUMOVAX23  had not been administered to the patient at the time of the report. The outcome of patient had titers drawn was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with PNEUMOVAX23 (dose, route and lot # were not reported). It was reported that on unspecified date the patients may have received more than one dose of PNEUMOVAX23. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever 102, body aches, chills for about 2 days.  Day of vaccine-no pain. Did a round of golf in the evening.  Painful next morning when woke up.  Arm is painful when try to lift at the shoulder.  Pt states "feels like muscle is gone". Has not been able to do her normal work out activities since vaccine-pt is normally very active.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Grip strength decreased, Hypoaesthesia, Paraesthesia, Rash
Clinical narrative: This spontaneous report was received from a nurse refers to a 12 year old female patient. The patient's medical history included exposed to pertussis on 02-JUN-2014, prescribed azithromycin for five days. There were not drug reaction or allergies. On 02-JUL-2014 the patient was vaccinated with GARDASIL injection, 0.5 ml, intramuscular in the left thigh, lot # J006850, expiration date 31-MAR-201. Concomitant therapies included diptheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, MENVEO and BOOSTRIX all of them administered on 02-JUL-2014 intramuscularly on the right thigh. The nurse informed that approximately in July 2014 (also reported as after receiving GARDASIL) the patient experienced numbness and tingling of hands, weakness of finger strength and bumps on the palms of her hands, the left hand being worse that the right hand, for approximately the past two weeks, after receiving GARDASL. The patient was seen in office by physician, and was referred to neurologist. The patient was followed up with the physician if symptoms worsen or there was not improvement. The nurse also mentioned that the patient's sister, who was three years of age, and red bumps on her hands, but was not seen in the office. As treatment the patient was referred to the neurologist. There were not laboratories diagnostics performed. Additional information has been requested