chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration, Product quality issue, Therapy non-responder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 39-year old female patient who received ENGERIX B adult (batch number ZR2M5, expiry date 16th April 2018. Co-suspect products included ENGERIX B adult (batch number 79ZS7, expiry date 4th June 2018) and ENGERIX B adult (batch number A9LB7, expiry date 7th July 2018). On an unknown date, the patient received the 1st dose of ENGERIX B adult (intramuscular) 1 ml and the 2nd dose of ENGERIX B adult (intramuscular) 1 ml. On 28th June 2016, the patient received the 3rd dose of ENGERIX B adult (intramuscular) 1 ml. On 28th June 2016, not applicable after receiving ENGERIX B adult and ENGERIX B adult and an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too short. On 31st August 2016, the patient experienced therapy non-responder. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too short and pharmaceutical product complaint were unknown. It was unknown if the report considered the therapy non-responder to be related to ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details were provided as follows: The reporting pharmacist was the dispensing pharmacist. The age at vaccination was not reported. The regimen used was 3 doses on a schedule of 0, 4 weeks and 12 weeks later. On 28th June 2016, the patient received 3rd dose of ENGERIX B adult, which led to shortening of the vaccination schedule. The patient who was a healthcare worker at the facility received 3 doses of ENGERIX B adult in her deltoid. On 31st August 2016, 64 days after receiving 3rd dose of ENGERIX B adult , the patient underwent laboratory test, which showed anti-HBsAG level less than 10 mlU/ml drawn. There were 2 more healthcare workers at the facility (US2016128146 and US2016GSK131991), who had experienced the same outcome after three doses of ENGERIX-B.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Dizziness
Clinical narrative: This case was reported by a nurse sales rep and described the occurrence of felt faint in a 16-year-old female patient who received BEXSERO. Co-suspect products included Hepatitis A vaccine and MENACTRA. On 1st September 2016, the patient received BEXSERO (intramuscular), Hepatitis A vaccine and MENACTRA. On 1st September 2016, less than a day after receiving BEXSERO and Hepatitis A vaccine, the patient experienced felt faint. On an unknown date, the outcome of the felt faint was not recovered/not resolved.  It was unknown if the reporter considered the felt faint to be related to BEXSERO and Hepatitis A vaccine. Additional details were provided as follows: the patient received BEXSERO and Hepatitis A vaccines on her arm. the patient also received a dose of MENACTRA concomitantly on her arm. the patient felt like fainting after vaccination. the manufacturer of co-suspect vaccine Hepatitis A was unknown. the lot number and expiration date of the vaccines were unknown. the sales representative noted that the office had files a VAERS report. This case has been linked with US2016128111 (twin's case), reported by the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant 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 PEDVAXHIB (lot # M020100, expiration date 07-MAR-2019; dose and route were unknown). The vaccines were exposed to temperature excursion of 1 degree centigrade for 12 hours and 1 degree centigrade for 10 hours. There were no previous temperature excursions. Data logger was involved. No adverse effect 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.
Age: 3.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Two doses of TDAP given instead of one dose of DTAP.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (therapy type was rHA, dose and route were unknown, lot # L029266 with expiration date 04-AUG-2017, lot # L039612 with expiration date 07-OCT-2017, lot # L037356 with expiration date 28-SEP-2017, and lot # L036853 with expiration date 24-SEP-2017). The vaccines were exposed to temperature excursion of 57.0 degrees Fahrenheit (F) for 1 hour and 50.8 degrees Fahrenheit (F) for 1 hour. No previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Tdap given instead of Dtap.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 29-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L041296; dose, route of administration and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. 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 medical assistant refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Concentration, dose and route were not reported), lot # L039660, expiration date 04-FEB-2018. Patients' concomitant therapy was not reported. No adverse effect was reported. A product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Physician (MD) concerning a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. Concomitant therapies were not provided. On an unknown date, the patient was vaccinated with an unspecified dose of PEDVAXHIB (lot number J016188 with an unspecified expiration date in October 2016) (strength, dosage schedule, route of administration and anatomical location were not provided), which was involved in a temperature excursion. It was unknown whether laboratory diagnostics studies were performed. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
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 patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (therapy type was rHA, dose, and route were unknown, lot # and expiration date were L050907, 14-JUN-2017; M002058, 11-JUL-2017; M006107, 01-AUG-2017; M011661, 08-SEP-2017). No adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Full blood count, Injection site cellulitis, Metabolic function test
Clinical narrative: Cellulitis at injection site, dx in ED.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an 85 year old male patient concerning himself. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX, route of administration was reported as "vaccine" (strength, dosage schedule, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medication were not provided. On 19-JUL-2016, the patient experienced herpes zoster described as "he thinks, he is going to get the shingles in his right side of his body where his breast is at". On unspecified dates in 2016, he sought medical attention, he went to see three doctors, he also visited the emergency room, and then, he visited a regular doctor, but this one could not find anything. It was reported that unspecified treatment was given for the adverse event. Also, the patient stated that on approximately 29-AUG-2016 (reported as "on Monday"), he would have an appointment to see "what he has". No product quality complain was involved. The outcome of herpes zoster was unknown at the time of reporting. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information is not expected because the reporter did not consent for further follow up.
Age: 17.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Sweating, lightheadedness, nausea - occurred 6-8 hrs post vaccination.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a Speaker (other health professional) who was participating in an industry/regulatory/academic consortium via company representative referring to a unspecified patient of unknown ages and genders. The patients were immune compromised individuals. On unknown dates, the patients were vaccinated with unspecified commercial rubella vaccine; it was unknown if it was (Oka-Merck) PROQUAD, M-M-R II or one for another source. The lot numbers, expiration dates, doses, routes, frequencies were not reported. On unknown dates, the patients developed severe rash, and the reporting health professional stated that the causative agent of this adverse event, based on deep sequencing and specific Polymerase chain reaction (PCR), was the commercial rubella vaccine (it was not clear if it was (Wistar RA 27-3) M-M-R II or (Oka-Merck) PROQUAD). The outcome of severe rash was unknown. The reporter considered the rash was related to (Wistar RA 27-3) M-M-R 11 or (Oka-Merck) PROQUAD. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient states that she is experiencing tiny red rashes all along the torso, the chest, and legs.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Patient states that she is experiencing tiny red rashes all along the torso, the chest, and legs.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient states that he experiencing ting red rashes all along the torso, chest, and legs. Pt states it began the day after shot.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Patient states that he experiencing ting red rashes all along the torso, chest, and legs. Pt states it began the day after shot.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old female patient with drug reactions/allergies to aminoglycosides, macrolides, ketolides, oxycodone and potassium. On 03-JUL-2015, she received a dose of PREVENAR 13. On 02-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 injection, lot # M005287, expiration date: 08-OCT-2017, intramuscularly in the right arm (exact dose was not reported). On 02-SEP-2016 (also reported as "on 03-SEP-2016"), the patient experienced swollen injection site on her right arm. The pharmacist requested a lot check which was time sensitive. The outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Fever x 24 hours, cough, vomited x3, sore throat.
Age: 69.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Rash, swelling and redness surrounding L arm injection site. Symptoms occurred 3 days after injection.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Flank pain, Myalgia, Pain, Vascular pain
Clinical narrative: Patient came back to pharmacy 3 days after receiving the immunization complaining of muscle pain, throbbing of hand veins and a stabbing pain on the left side of her body.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Tdap given instead of DTaP no adverse symptoms/signs.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Electrocardiogram, Loss of consciousness, Seizure, Urine analysis
Clinical narrative: Received third GARDASIL (GARDASIL 9) 9/2 had a seizure 6hrs after. 10 days later passed out three times did not realize she was on the ground pt thought she was standing up. Each episode lasted about 10min. 2nd and 3rd were 15 min apart. Received GARDASIL 4 1st and 2nd dose.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: Constant headaches associated with nausea, neck stiffness upon awakening, patient seen at the office for f/u.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Blister, Chills, Dermatitis, Headache, Malaise
Clinical narrative: 23 yo female received Smallpox vaccine on 7 AUG 2016. Patient reported she developed a rash approx. day 13 post smallpox vaccination. Dermatitis characterized by small discrete scattered pruritic papules to shoulders, upper extremities, anterior lower extremities, and a few on her chest and under her bra. There are no pustules, vesicles, plaques. The dermatitis has been improving and pruritus has diminished. Papules are barely visible, but are palpable. Patient denies fever chills malaise headache, myalgia or arthralgia. Description of vaccine site, "looks great" (per medics) scab intact and no peripheral satellite areas. No new treatments and there has been no new identifiable exposures.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Papule, Rash, Rash pruritic, Scab, Skin plaque
Clinical narrative: 23 yo female received Smallpox vaccine on 7 AUG 2016. Patient reported she developed a rash approx. day 13 post smallpox vaccination. Dermatitis characterized by small discrete scattered pruritic papules to shoulders, upper extremities, anterior lower extremities, and a few on her chest and under her bra. There are no pustules, vesicles, plaques. The dermatitis has been improving and pruritus has diminished. Papules are barely visible, but are palpable. Patient denies fever chills malaise headache, myalgia or arthralgia. Description of vaccine site, "looks great" (per medics) scab intact and no peripheral satellite areas. No new treatments and there has been no new identifiable exposures.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: 6 cm x 7 cm patch raised red irritated on left deltoid.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Local reaction, Pruritus
Clinical narrative: Pt has localized reaction - inflammation & itching.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of VAQTA (Concentration, dose and route were not reported), lot # M011116, expiration date 17-JUN-2017. Patients' concomitant therapy was not reported. No adverse effect was reported. A product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: Information has been received from a certified medical assistant (C.M.A) concerning a 23 year old female patient. The patient's obstetric history included 2 previous pregnancies with 2 full term deliveries without birth defects or infant complications in pregnancies. The patient's concurrent conditions, pertinent medical history, drug reactions and allergies were not reported. Concomitant medications included unspecified pregnancy vitamins. On 21-JUL-2016, the patient was vaccinated with the 3rd dose of GARDASIL 9 (lot number M005714) (strength, dose, route, anatomical location and expirati0on date were not reported). Other suspect medications were not provided. On unknown date, the patient became pregnant with an estimated date of last menstrual period (LMP) of 01-MAY-2016 and estimated delivery date (EDD) of 10-MAR-2017 determined by an ultrasound, which was performed on 03-AUG-2016. At the time of reporting, the pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot #, dose and expiration date were not reported) subcutaneous. Concomitant medications were not reported. On an unknown date, 3 weeks after vaccination, the patient experienced shingles. The outcome of shingles was unknown. The relatedness between shingles and ZOSTAVAX. 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 medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M001152 (exact dose, expiration date, therapy type and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of M-M-R II (rHA) (Concentration, dose and route were not reported), lot # L041456, expiration date 22-OCT-2017. Patients' concomitant therapy was not reported. No adverse effect was reported. A product quality complaint (PQC) was not involved. 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 was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored RECOMBIVAX HB 0.5 ml, lot # L048849 with expiration date: 04-FEB-2018 (route of administration was not reported). Administered doses of RECOMBIVAX HB underwent temperature excursions at 9.5 Celsius degrees, for 1 hour and 10 minutes. Data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-AUG-2015, the patient was vaccinated with GARDASIL 9 dose 1, lot # L007560, expiration date 15-JUN-2017 (strength, route and anatomical location of administration were not reported). On 16-DEC-2015, the patient was vaccinated with GARDASIL 9, dose 2, lot # L0255737, expiration date 27-JUL-2017 (strength, route and anatomical location of administration were not reported). On 16-FEB-2016, the patient was vaccinated with GARDASIL 9, dose 3, lot # L045711, expiration date 08-MAY-2017 (strength, route and anatomical location of administration were not reported). The nurse reported that the patient received doses of GARDASIL 9 outside the recommended series schedule intervals. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of GARDASIL (Concentration, dose and route were not reported), lot # M005714, expiration date 03-OCT-2017. Patients' concomitant therapy was not reported. No adverse effect was reported. A product quality complaint (PQC) was not involved. This is one of several reports 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 medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M001152 (exact dose, expiration date, therapy type and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from an unknown reporter referring to a 8 year old male patient. The patient's medical history and concurrent conditions were not reported. On 30-JUN-2016, at 15:54, the patient was vaccinated with an expired dose of M-M-R II (rHA, lot # K008625, expiration date 16-JUN-2016), 1st dose, subcutaneously in the left deltoid. He was also vaccinated, on the same date, at 14:30 with the 1st dose of BOOSTRIX, in the left deltoid, intramuscularly. No adverse effects were reported. This is one of four cases from the same reporter source, (linked to MARRS # 1607USA000647, 1609USA005772, and 1609USA005773). Additional information is expected.
Sex: U
Vaccine: VARCEL
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 patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose, and route were unknown, lot # and expiration date were L042265, 26-OCT-2017; L049535, 08-DEC-2017; M010480, 01-MAR-2018). No adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant 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 GARDASIL 9 (lot # M018810, expiration date 28-MAY-2018; dose and route were unknown). The vaccines were exposed to temperature excursion of 1 degree centigrade for 12 hours and 1 degree centigrade for 10 hours. There were no previous temperature excursions. Data logger was involved. 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: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant 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 M-M-R II (recombinant human albumin (rHA), lot # L035674, expiration date 17-SEP-2017; dose and route were unknown). The vaccines were exposed to temperature excursion of 12 degree centigrade for 10 hours. There were no previous temperature excursions. Data logger was involved. 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.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 61 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-MAR-2016, the patient received dose of improperly stored ZOSTAVAX lot number L035283, expiry date: 15-DEC-2016; (the dose, dosage number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 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: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received form a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-JUN-2016, the patient was vaccinated with an improperly store dose of (Oka-Merck) PROQUAD lot # M001152 (exact dose, expiration date, therapy type and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 79.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 79 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-JAN-2016, the patient received dose of improperly stored ZOSTAVAX lot number L029484, expiry date: 06-NOV-2016; (the dose, dosage number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 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: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection, lot # L014428, expiration date: 12-MAR-2018, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. The certified medical assistant was unable to provide exact temperatures at the time of reporting, but stated they "went to 32 degrees Fahrenheit or lower" and they were out of range for "15 minute increments, 40 times". No specific cumulative time was reported. The temperatures were reported by a data logger and according to the reporter they were back in range at the time of report. There were no prior excursions reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of three 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 as received from a nurse (also reported as a medical assistant), refers to an unspecified number of patients of unknown age and gender. No information on patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were orally administered improperly stored doses of ROTATEQ, lot # L039640, expiration date: 24-AUG-2017 (dose not reported). The administered doses experienced a temperature excursion of 33.4 degrees Fahrenheit for 7 hours. The temperature excursion was detected by a data logger. There were no previous temperature excursions. No adverse effects were reported. This is one of two reports from the same reporter.  Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to 60 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-FEB-2016, the patient received dose of improperly stored ZOSTAVAX lot number L029484, expiry date: 06-NOV-2016; (the dose, dosage number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 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: Information has been received from a medical assistant 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 VARIVAX (lot # L011084, expiration date 01-APR-2017; dose and route were unknown). The vaccines were exposed to temperature excursion of 12 degree centigrade for 10 hours. There were no previous temperature excursions. Data logger was involved. 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: MMRV
Symptoms: Incorrect product storage, No adverse event
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 concurrent conditions, concomitant therapies or medical history provided. On 17-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M001152 (exact dose, expiration date, therapy type and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M010440, expiration date: 09-DEC-2018) (dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursions of 9.5 degrees for 1 hour and 10 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: DTAP, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from an unknown reporter referring to a 4 year old female patient. The patient's medical history and concurrent conditions were not reported. On 30-JUN-2016, at 15:56, the patient was vaccinated with an expired dose of (wistar ra 27-3) M-M-R II (rHA, lot # K008625, expiration date 16-JUN-2016), 1st dose, subcutaneously in the left deltoid. She was also vaccinated, on the same date, at 15:10 with the 1st dose of INFANRIX, in the left deltoid, intramuscularly. No adverse effects were reported. This is on of four cases form the same reporter source, (linked to MARRS # WAES1607USA000647, WAES1609USA005771, and WAES1609USA005773). Additional information is expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified multiple patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and drug reactions/allergies were not provided. On unknown dates, the patient were vaccinated with improperly stored doses of PROQUAD (rHA, lot # M018636, expiration date 11-OCT-2016; dose was unknown). The vaccines were stored at 7.5 Fahrenheit degree for 2 hours 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Product quality issue
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On an unknown date, the patient vaccinated with ZOSTAVAX 19400 PFU (dose and strength unknown, lot number L046295, expiration date 17-FEB-2017) that had bubbles, subcutaneously. Product quality issue was involved (00168231). No symptoms were reported. Additional information is not expected as the pharmacist refused to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 24-AUG-2016, the patient was inadvertently vaccinated an expired dose of PROQUAD (dose and route unknown, lot # L005294, expiration date 17-AUG-2016). No adverse effect was reported. Additional informati0on has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (also reported as a medical assistant), refers to an unspecified number of patients of unknown age and gender. No information on patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L026602, expiration date: 19-OCT-2017 (dose, frequency and route of administration were not reported). The administered doses experienced a temperature excursion of 33.4 degrees Fahrenheit for 7 hours. The temperature excursion was detected by a data logger. There were no previous temperature excursions. No adverse effects were reported. This is one of two reports 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 medical assistant 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 RECOMBIVAX HB (lot # K024552, expiration date 22-OCT-2016; dose and route were unknown). The vaccines were exposed to temperature excursion of 1 degree centigrade for 12 hours and 1 degree centigrade for 10 hours. There were no previous temperature excursions. Data logger was involved. 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: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA, lot # L009445, expiration date: 01-JUN-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. The certified medical assistant was unable to provide exact temperatures at the time of reporting, but stated they "went to 32 degrees Fahrenheit or lower" and they were out of range for "15 minute increments, 40 times". No specified cumulative time was reported. The temperatures were recorded by a data logger and according to the reporter they were back in range at the time of report. There were no prior excursions reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of three 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 as received from a certified medical assistant refers to multiple patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # L033693, expiration date: 31-MAY-2017, (dose and dose number were not provided). There were no concomitant medications reported. The certified medical assistant was unable to provide exact temperatures at the time of reporting, but stated they "went to 32 degrees Fahrenheit or lower" and they were out of range for "15 minute increments, 40 times". No specific cumulative time was reported. The temperatures were recorded by a data logger and according to the reporter they were back in range at the time of report. There were no prior excursions reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of three reports received 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 medical assistant 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 ROTATEQ (lot # L026741, expiration date 18-MAY-2017; dose and route were unknown). The vaccines were exposed to temperature excursion of 1 degree centigrade for 12 hours and 1 degree centigrade for 10 hours. There were no previous temperature excursions. Data logger was involved. 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.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Malaise, Syncope
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Alanine aminotransferase normal, Anion gap normal, Aspartate aminotransferase normal, Asthenia, Basophil count decreased
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Basophil count normal, Basophil percentage decreased, Bilirubin urine, Blood albumin decreased, Blood alkaline phosphatase normal
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Blood bilirubin normal, Blood calcium increased, Blood chloride normal, Blood creatine phosphokinase normal, Blood creatinine normal
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ
Symptoms: Blood culture negative, Blood glucose normal, Blood lactic acid decreased, Blood potassium normal, Blood sodium normal
Clinical narrative: This spontaneous report was received from a nurse manager via company representative regarding a 16 year old female patient. The patient's medical history, concomitant medications and other relevant tests were unknown. On an unknown date in August 2016, the patient was vaccinated with GARDASIL (dose unknown). On the same day, she was also vaccinated with MENACTRA (dose unknown) intramuscularly and TRUMENBA (dose 1, 0.5 ml). The patient received all three vaccines at the same time. Approximately on 25-AUG-2016 (reported as last Thursday), she fainted and later felt better. Later the child did not feel well and was taken to the hospital. It was not known if the patient had been admitted to the hospital or not. The outcome of the events were unknown but thought that the patient as back home now. The reporter did not provide the relatedness of the events with the vaccines. Additional information has been requested.