chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and the office manager refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # K024036, expiry date 26-NOV-2016, strength, dose, route and site of administration were not reported). No adverse symptoms were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 18 year old patient of unknown gender. On 13-APR-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L026602 with expiration date 19-OCT-2017). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and the office manager refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # L004014, expiry date 04-MAR-2017 (strength, dose, route and site of administration were not reported0. No adverse symptoms were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD lot # M004897, expiration date: 26-JUL-2017, 0.5 ml. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nausea in a 38-year-old female patient who received BOOSTRIX (batch number B3G4G, expiry date-5th NOVEMBER-2017). On an unknown date, the patient received BOOSTRIX .5ml. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced nausea, headache and vomiting. On an unknown date, the outcome of the nausea, headache and vomiting were unknown. The reporter considered the nausea, headache and vomiting to be related to BOOSTRIX. Additional details were provided as follows: The reporter stated that, the patient experienced adverse events (nausea, headache and vomiting) associated with BOOSTRIX vaccination. It is unknown if the side effects resolved. The reporter would like to be contacted regardless if there were similar reported adverse events associated with this specified lot number or not. The reporter was nervous because she used to buy BOOSTRIX in bulk. This case has been linked with case US2016GSK105719, reported by the same reporter..
Sex: F
Vaccine: HEPA
Symptoms: Accidental exposure to product, Eye irritation, Immediate post-injection reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of eye irritation in a female patient who received HAVRIX pediatric (batch number 002717?, expiry date 2nd JUNE 2017). On an unknown date, the patient received HAVRIX pediatric .5ml. On an unknown date, immediately after receiving HAVRIX pediatric, the patient experienced eye irritation and inadvertent exposure to vaccine. On an unknown date, the outcome of the irritation was recovering/resolving and the outcome of the inadvertent exposure to vaccine was unknown. The reporter considered the eye irritation to be related to HAVRIX pediatric. Additional details were provided as follows: The age at vaccination was not applicable. The reporter stated that while administering HAVRIX pediatric to the infant patient, the patient moved and some of the vaccine squirted into the patient's mother's eye. This led to accidental exposure to vaccine and the patient's mother experienced eye irritation. The reporter would like safety information for the patient's mother. The reporter would also like revaccination information for the infant patient. This case has been linked with the case US2016GSK127686 reported by the same reporter.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse, via a company representative referring to 2 adolescent female patients of unknown age. Patients' medical history, concurrent conditions or concomitant therapies were not reported. On an unspecified date, the patients were vaccinated with GARDASIL (dose, lot number, expiration date and administration route were not provided). On an unknown date, the patients experienced syncope, also it was reported that the patients "did not eat prior to receiving the vaccine". The outcome of syncope was reported as recovered/resolved. The causal relationship between therapy with GARDASIL and the syncope was reported as unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. The pharmacist stated that the patient potentially received an expired dose of ZOSTAVAX (lot #, expiration date, route and dose were unknown) on an unknown date. The pharmacist was investigating if this dose was actually administered. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2016, the patient was vaccinated with the improperly stored dose of M-M-R II (lot # L026553, albumin status rHA; dose, route, expiration date were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 01-JUL-2016, the patient was vaccinated with an incorrectly stored dose of VARIVAX (lot # L045953, dose and route of administration were not reported). Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt noticed redness and pain at injection site on 8/26/16. Two days later on 8/28/16 she went to the ER where they gave her steroids and antibiotics. She followed up with her PCP and is not completely healed, but said she is getting better every day.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Seizure, Vaccination complication
Clinical narrative: High fever, seizure, rash tx w/TYLENOL. Suspect from MMR vaccine.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever of 102.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Blood test, Intussusception, Surgery, Suture insertion, Urine analysis normal
Clinical narrative: I was given the Zoster vaccine on Feb 24, 16 and ended up with intussusception. I suffer for 5 months and two days and I told my doctor I believe that vaccine hurt me and he call it stress well 8-3-16 I was operated on. I still have staple. Went to hospital they only took blood and urine. Set one in hall way then said can't find anything.
Age: 9.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: Pt was given the wrong vaccine. Pt was given MENACTRA. She was to receive Hep A.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Morning after Pt received MCV4 vaccine, developed pain, redness and induration surrounding injection site. No necrosis. Improving at time of evaluation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site vesicles, Vaccination site eschar
Clinical narrative: Pt. received vaccines KINRIX and PROQUAD 8/18 - 8/20/16 in office with red, blistered vaccine sites. (2.5 x 2.5 inches of redness with 1 x .75 inches of blistered area) lower  vaccine site. Dr also reports area of eschar in center. Rc'd AUGMENTIN.
Age: 3.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Patient's Mom noticed "bumps" on pt. 9/5/16. Pt. was seen 9/6/16 and DX with chicken pox by Dr.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Increased upper airway secretion, Malaise, Oropharyngeal pain
Clinical narrative: Soreness of throat. Mucous production increase in throat; ill feeling, prolonged.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Fever 6 hours after vaccine given, rectal 102.1 degrees F.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning, three unspecified patients (unknown ages and genders). Medical history of the patients and their concurrent conditions were not informed. It was reported that on 03-AUG-2016 the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # L043214, expiration date 30-AUG-2017(concentration, dosage and therapy route were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved at the time of the report. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age and gender. On an unspecified date in 2016, the patient was vaccinated with an expired dose of VARIVAX (lot number K011801, expiry date 21-AUG-2016, subcutaneous, dose not reported). The reporter stated that the patient did not report any adverse effects or any other issues following the administration of this VARIVAX. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Malaise
Clinical narrative: Prolonged ill feeling.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of redness in a adolescent patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced redness and pain. On an unknown date, the outcome of the redness and pain were recovered/resolved. It was unknown if the reporter considered the redness and pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness and soreness, but location of the redness and soreness was not specified. The specifics of the events were unknown, but the issues were believed to have resolved within a few days. This case has no been reported to VAERS. All questions were asked, but limited information was provided by the sales representative. This case has been linked to case US2016122905, reported by the same reporter.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Cold sweat, Crying, Pallor, Peripheral coldness, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of coldness of skin in a female patient who received BEXSERO. The patient's past medical history included anxiety disorder. On an unknown date, the patient received BEXSERO (intramuscular). On an unknown date, several hours after receiving BEXSERO, the patient experienced coldness of skin, clamminess, fever, looked pale, crying uncontrollable and tremor. On an unknown date, the outcome of the coldness of skin, clamminess, fever, looked pale, crying uncontrollable and tremor were unknown. The reporter considered the coldness of skin, clamminess, fever, looked pale, crying uncontrollable and tremor to be probably related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the 16 to 18 years old patient experienced fever (100.6 degree F), looked pale, was cool and clammy to the touch, was crying hysterically and shaking uncontrollably after vaccination with BEXSERO. The reporter would be on vacation next week from reporting date and back of contact details of practice manager were reported. This case is one of the four cases reported by the same reporter.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Tremor
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of coldness of skin in a female patient who received BEXSERO. The patient's past medical history included anxiety disorder. On an unknown date, the patient received BEXSERO (intramuscular). On an unknown date, several hours after receiving BEXSERO, the patient experienced coldness of skin, clamminess, fever, looked pale, crying uncontrollable and tremor. On an unknown date, the outcome of the coldness of skin, clamminess, fever, looked pale, crying uncontrollable and tremor were unknown. The reporter considered the coldness of skin, clamminess, fever, looked pale, crying uncontrollable and tremor to be probably related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the 16 to 18 years old patient experienced fever (100.6 degree F), looked pale, was cool and clammy to the touch, was crying hysterically and shaking uncontrollably after vaccination with BEXSERO. The reporter would be on vacation next week from reporting date and back of contact details of practice manager were reported. This case is one of the four cases reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Chest discomfort, Crying, Headache
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of chest tightness in a 11-year-old patient who received BEXSERO. On 22 August 2016, the patient received BEXSERO. On 22nd August 2016, less than a day after receiving BEXSERO, the patient experienced chest tightness, crying and headache. The patient was treated with oxygen. On an unknown date, the outcome of the chest tightness, crying and headache were unknown. It was unknown if the reporter considered the chest tightness, crying and headache to be related to BEXSERO. Additional details were provided as follows: This case was reported by a medical assistant. The age at vaccination was not reported. The reporter was administering oxygen to the patient when contacted to report the adverse event and requested to be connected with Medical Information. No additional information was available at time of reporting.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling cold, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, pain, arm pain, aches and chills for one week. Took TYLENOL. Symptoms began to develop 30 minutes following injection.
Age: 59.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Inflammation, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Injection site became swollen and red. Area about 5 inches (circle). Patient complained about pain and inflammation.
Age: 15.0
Sex: M
Vaccine: HEPAB
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A dose of TWINRIX was administered to a 15 year old instead of separate Hep A and Hep B for a pediatric age range. TWINRIX is indicated for 18 years and up.
Age: 43.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Diarrhoea, Nausea, Pyrexia, Rash
Clinical narrative: Information has been received from a licensed practical nurse referring to a 43 year old female patient who was not pregnant. The patient did not have pertinent medical history. The patient was allergic to BACTRIM. Concomitant therapies included BYSTOLIC and SYMBICORT. On 24-AUG-2016, the patient was vaccinated with M-M-R II (rHA, 0.5ml, once, lot # L015280, expiration date 30-APR-2017) intramuscularly. On 27-AUG-2016, the patient experienced fever, rash, joint pain, nausea, vomiting and diarrhea. It was reported that on 30-AUG-2016, the patient was seen in office by an unspecified physician, and received unspecified treatment. There was no lab diagnostics test performed. The adverse events were reported to Vaccine Adverse Event Reporting System (VAERS). At the time of reporting, the outcome of the events was unknown. The relatedness between fever, rash, joint pain, nausea, vomiting and diarrhea and M-M-R II was not reported. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse referring to a 43 year old female patient who was not pregnant. The patient did not have pertinent medical history. The patient was allergic to BACTRIM. Concomitant therapies included BYSTOLIC and SYMBICORT. On 24-AUG-2016, the patient was vaccinated with M-M-R II (rHA, 0.5ml, once, lot # L015280, expiration date 30-APR-2017) intramuscularly. On 27-AUG-2016, the patient experienced fever, rash, joint pain, nausea, vomiting and diarrhea. It was reported that on 30-AUG-2016, the patient was seen in office by an unspecified physician, and received unspecified treatment. There was no lab diagnostics test performed. The adverse events were reported to Vaccine Adverse Event Reporting System (VAERS). At the time of reporting, the outcome of the events was unknown. The relatedness between fever, rash, joint pain, nausea, vomiting and diarrhea and M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse manager and refers to unspecified school age children of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates in 2015 (reported as "between 16-OCT-2015 and 01-DEC-2015"), the patients were vaccinated with dosed of improperly stored PROQUAD lot # L023113, expiration date 24-DEC-2016 (dose and route of administration not reported). The vaccines with lot # L023113 underwent a temperature excursion up to 21 degrees Fahrenheit for 4 hours. On unknown dates in 2016 (reported as "between 19-JAN-2016 and 08-MAR-2016") school age children were vaccinated with doses of improperly stored PROQUAD lot # L045675, expiration date 19-MAY-2016 (dose and route of administration not reported). The doses of PROQUAD with lot # L045675 underwent the temperature excursion up to 15 degrees Fahrenheit for 7 hours. No adverse effect or side effect were reported. This is on of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from health care worker referring to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, 0.5 ml, subcutaneously, which had lot # L043213 and expiry date: 28-AUG-2017. The vaccine had unspecified temperature excursion on 19-JUL-2016. No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On multiple unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose and route unknown, lot# L040053, expiration date: 10-MAY-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses ROTATEQ which had lot # L027076 and expiry date: 25-MAY-2017 (dosing details not provided). The vaccine had unspecified temperature excursion on 19-JUL-2016. No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from health care worker referring to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II which had not # L027591 and expiry date: 23-JUL-2017 (dosing details not provided). The vaccine had unspecified temperature excursion on 19-JUL-2016. No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse manager and refers to a unspecified school age children of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates in 2015 (reported as "in the time period between 16-OCT-2015 and 20-NOV-2015"), the patients were vaccinated with doses of improperly stored VARIVAX lot # L016125, expiration date 16-MAY-2017 (dose and route of administration were not reported). On unspecified dates in January 2016 (reported as "in the time period between 22-JAN-2016 and 30-JAN-2016), the school age children received doses of improperly stored VARIVAX lot # L035129, expiration date 14-SEP-2017 (dose and route of administration not reported). On unknown dates in 2016 (reported as "between 23-MAY-2016 and 22-JUL-2016"), the patients were administered doses of improperly stored VARIVAX lot # L046885, expiration date 23-NOV-2017 (dose and route of administration not reported). On 23-JUL-2016, the patients were vaccinated with doses of improperly stored VARIVAX lot # L037559, expiration date 29-SEP-2017 (dose and route of administration not reported). The doses of VARIVAX with lot # L016125 and lot # L046885 underwent a temperature excursion up to 15 degrees Fahrenheit for 7 hours while the temperature excursion for VARIVAX with lot # L035129 and lot # L046885 was up to 21 degrees Fahrenheit for 4 hours. No adverse effects or side effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately August 2016 (it was reported that vaccines were administered on 22-AUG-2016, 23-AUG-2016, 24-AUG-2016 and 25-AUG-2016, but it was unknown which patient received doses on which date), the patient was accidentally vaccinated with 2 doses of RECOMBIVAX HB, intramuscularly, lot # M023892, expiry date 17-SEP-2017 (strength, dose and site of administration were not reported). No adverse reactions were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On multiple unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose and route unknown, lot#L048236, expiration date:31-MAR-2018). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator referring to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 which had lot # L024993 and expiry date: 17-OCT-2017, (dosing details not provided). The vaccine was exposed to temperature of 45.5 degree Fahrenheit for 3 hours and 30 minutes. The vaccine had no previous temperature excursion. The call was because of data logger. No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Erythema, Incorrect route of drug administration, Pruritus, Swelling
Clinical narrative: Information has been received from a register nurse concerning a patient of unknown age and gender. There was no concurrent condition, medical history and concomitant therapy reported. On 16-MAY-2016, the patient received a dose of M-M-R II (lot#, dose not provided), intramuscularly rather than subcutaneously. No adverse effect was reported. Follow up information has been received from the physician on 08-AUG-2016. On 16-MAY-2016, patient received second dose of M-M-R II, lot L034930, in the right leg. On 17-MAY-2016, patient experienced redness, itching and swelling. Events were not associated with any of the seriousness criteria. Illness at the time of vaccination was reported as none. The outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested. Product, events and narrative were updated.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-AUG-2016, the patient was vaccinated with expired dose of ROTATEQ (lot # L000569, expiry date: 13-JUL-2016) once (route: oral) (expired vaccine used). It was reported that ROTATEQ did not experience any temperature excursion. No adverse effect reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to multiple patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # M000998, expiration date: 07-JAN-2018, dose and route of administration were not provided) that were improperly stored. No adverse effect were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant medications were reported. On an unspecified date in 2016, the unspecified patients were vaccinated with 0.5 ml doses of (wistar ra 27-3) M-M-R II subcutaneously (lot # L027431, expiration date 22-JUL-2016) after the temperature excursion on 01-JUN-2016. The vaccines were stored in 8.8 Celsius degrees for 40 minutes. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 26-AUG-2016, the patient was inadvertently vaccinated with ZOSTAVAX (once, strength, lot# and expiration date were not reported) subcutaneously. Instead of VARVIAX. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via consumer (patients wife) regarding her husband who is his 80s. Pertinent medical history and drug reactions were unknown by the reporter. Approximately on an unknown date of 2010 (reported as about 6 years ago) the patient was vaccinated with ZOSTAVAX (unknown lot number and expiration date) at an unknown pharmacy. Concomitant medications were unknown by the reporter. On an unknown date (reported as a couple of days ago) the patient was diagnosed with an active case of shingles (herpes zoster). The outcome of herpes zoster was reported as not recovered. Causality assessment was not provided by the reporter. No PQC filed. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator referring to multiple unknown patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II which had lot # L032182 and expiry date: 25-AUG-2017, (dosing details not provided). The vaccine was exposed to temperature of 45.5 degree Fahrenheit for 3 hours 30 minutes. The vaccine had no previous temperature excursion. The call was because of data logger. No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 10-AUG-2016, the patient was vaccinated with incorrectly stored dose M-M-R II lot # L029266 (dose and route of administration were not reported). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant and refers to an unknown number of unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions or allergies were not reported. In approximately 2016, reported as on unknown dates starting on or after 11-JUL-2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L029306, expiration date: 26-MAR-2017 (dose and route of administration were not reported). Administered doses of vaccine experienced temperature excursion of 48 degree Fahrenheit for 30 minutes, on unknown date. There was no previous temperature excursion. No adverse effects were reported. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On multiple unspecified dates, the patients were vaccinated with improperly stored VAQTA (dose and route unknown, lot# L023232, expiration date: 25-FEB-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (strength, dose and frequency were unknown; subcutaneous, lot # L039092, expiration date 06-OCT-2017; lot # L048462, expiration date 02-DEC-2017; lot # M004329, expiration date 26-JAN-2018 and lot # L017142, expiration date 13-MAY-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 06-JUL-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L042266 (dose, strength, route of administration and expiry date were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and the office manager refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # L014878, expiry date 17-JAN-2018 (strength, dose, route and site of administration were not reported). No adverse symptoms were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea
Clinical narrative: This spontaneous report was received from a nurse practitioner (also reported as a certified nurse midwife (CNM)) refers to a non-pregnant female patient of unknown age. There was no information about the patient's concurrent conditions or medical history provided. On 23-JUL-2015, the patient was vaccinated with a dose of GARDASIL lot # K014191 with an expiration date: 10-OCT-2017 (dose and route of administration were not reported). On an unspecified date, approximately in 2015, after the administration of the dose of GARDASIL, the patient experienced headache and nausea which lasted for an unspecified amount of time. On 28-SEP-2015, the patient was vaccinated with the second dose of GARDASIL lot # L010596 with an expiration date: 05-APR-2017 (dose and route of administration were not reported). The patient's concomitant therapy included multiple unspecified medications. On an unspecified date, after the administration of the second dose of GARDASIL, the patient experienced headache and nausea again. The events lasted for an unspecified amount of time. No treatment was given for the adverse events. The outcome of the headache and nausea after each vaccination with GARDASIL was not reported. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and the office manager refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA lot # L07757, expiry date 08-APR-2018 (strength, dose, route and site of administration were not reported). No adverse symptoms were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, Tuberculin test positive
Clinical narrative: Information has been received from a nurse practitioner referring to a 13 year old male patient. The patient's medical history, concurrent condition and concomitant medication were not unknown. On an unknown date, the patient was vaccinated with PROQUAD (lot # M004893, expiration date 26-JUL-2017, dose unknown) subcutaneously (product use in unapproved population). At the same time, the patient received a purified protein derivative (PPD) tuberculin skin test, which was positive. There was no treatment given for the events. The patient did not seek medical attention. The outcome of the events was unknown. The relatedness between tuberculin skin test positive and PROQUAD was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients. The patient's medical history was not provided. On unknown dates, multiple unspecified patients were administered both ZOSTAVAX and PNEUMOVAX 23 together at the same visit (lot #, dose, route and site of administration were not reported for both). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M008551 and expiry date 02-JUN-2018 (dosing details not provided). The vaccine had unspecified temperature excursion on 19-JUL-2016. No adverse effects and no product quality complaint (PQC) reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Scab
Clinical narrative: This spontaneous report was received from a male adult consumer of an unknown age referring to him/herself. Patient's pertinent medical history, drug reactions and allergies were not reported. On unknown date in August 2015 (reported as "about one year ago"), the patient was administered ZOSTAVAX (dose, frequency, route of administration, lot # and expiration date were not provided). Information regarding concomitant therapy was not reported. Approximately on 10-AUG-2016 (reported as "2 weeks ago"), the patient developed shingles on his left torso and he stated that the vaccine worked like a charm. The patient has been self-treating with calamine lotion topically and oatmeal baths. At the time of the reporting, the patient was recovering from the event of shingles reported as his shingles lesions were crusting over. The patient reported that he had appointment scheduled with his physician on 01-SEP-2016. There was no product quality complaint IPQC) involved. Additionally, the reporter did not provide any causal relationship between the event and therapy with ZOSTAVAX. His shingles lesions are crusting over (recovering) but he still has itching and pain. The patient states he has an appointment scheduled with his physician on 01-SEP-2016. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 12-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L019999, expiration date 02-JUN-2017 (dose and route of administration were not reported). Concomitant therapy was not reported. The administered dose of vaccine was exposed to a temperature of 15.4 Fahrenheit degrees, for 13 hours 30 minutes. There were no previous temperature excursions. Temperature was back in range. Data logger was involved. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were unknown. On multiple unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (dose unknown, lot# L047185, expiration date: 17-SEP-2017) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 16-AUG-2016, the patient was inadvertently administered an expired dose of PROQUAD (expiration date 14-AUG-2016, lot number, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 21-JUL-2016, the patient was vaccinated with an incorrectly stored dose of (Oka/Merck) VARIVAX lot # L042266 (dose and route of administration were not reported). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner, via a company representative, referring to two female patient of unknown age. The patients' medical history, concurrent condition and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX (strength, dose, lot #, expiration date and route were not reported). It was reported that while on ZOSTAVAX, the two female patients experienced large amounts of swelling, pain and rashes near their respective injection sites. There was no lab diagnostics tests performed. The patient sought medical attention. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately August 2016 (it was reported that vaccines were administered on 22-AUG-2016, 23-AUG-2016, 24-AUG-2016 and 25-AUG-2016, but it was unknown which patient received doses on which date), the patient was accidentally vaccinated with 2 doses of RECOMBIVAX HB, intramuscularly, lot # M023892, expiry date 17-SEP-2017 (strength, dose and site of administration were not reported). No adverse reactions were reported. This is one of several cases received from the same reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 21-JUL-2016, the patient was vaccinated with an incorrectly stored dose of VARIVAX lot # L042266 (dose and route of administration were not reported). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDSAIL 9 (lot # L007560, expiration date 15-JUN-2017; strength, dose and frequency were unknown; intramuscular) and GARDASIL (lot # K007828, expiration date 02-MAR-2017; strength, dose and frequency were unknown; intramuscular) (interchange of vaccine products and overdose), which were exposed under temperature of 34.5  degrees Fahrenheit for 5 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.