chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 5 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 04-AUG-2014 the patient was vaccinated with a second dose of VARIVAX (Merck) (lot # J009728 with expiration date 07-AUG-2015; dose and router were not reported). On 27-AUG-2014, the patient was received the second dose of M-M-R II (lot# J013315 with expiration date 18-OCT-2015; dose and router were not reported) (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received  from a licensed practitioner nurse concerning an unknown number of patients of unknown age and gender. Since 19-MAR-2015, the patients were vaccinated with doses of improperly stored GARDASIL, lot # K023432, expiration date 18-JUN-2016 (dose and route not reported), which underwent supported temperature excursions. This is one of several reports received from the same source. 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 healthcare worker refers to an unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with improperly stored doses of Oral, ROTATEQ (lot # L000569, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Fever, sweats, redness, pain of injection site, swelling at inj. site - size of tennis ball. Pain in other jts and med. headache and nausea. Sx lasted 1-3 days.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: Fever, sweats, redness, pain of injection site, swelling at inj. site - size of tennis ball. Pain in other jts and med. headache and nausea. Sx lasted 1-3 days.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Barium enema normal, Haematochezia
Clinical narrative: Child developed bloody stools 2 days after receiving ROTATEQ. Child was seen in office, exam done and hematochezia confirmed. Child sent for barium enema which was negative for intussusception.
Age: 21.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to her son, a 21 year old male patient. In July 2015, about 1 month ago the patient was vaccinated with one dose of ZOSTAVAX (route, strength, lot# and dose were unknown) by an unspecified physician (inappropriate schedule of drug administration). No adverse reactions had been reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Gait disturbance, Injection site rash, Rash
Clinical narrative: Rash below inj. site that spread to her chest and neck. Complained of fatigue and difficulty walking day after shot. Doing better after taking antihistamine. Told to call MD.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a other health professional referring to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 05-AUG-2015 the patient was vaccinated with a dose of improperly stored M-M-R II lot # K002816, expiration date: 25-FEB-2015 (dose, dose #, route and application site were not reported). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal pain, Oedema, Pain in extremity
Clinical narrative: Developed erythema, edema, pain in arm, shoulder.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical  history and concurrent condition was not reported. On 02-APR-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K003520 with expiration date of 20-NOV-2016, dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain, Shoulder operation
Clinical narrative: Vaccine given in upper most part of shoulder causing blood to spurt at site. Within in one hour, acute pain and loss of range of motion. Resulting in many physician appts, numerous physical therapy sessions and eventual shoulder surgery. PT appts continue post surgery. Company Incident Report filed on 10/8/15. Work comp claim filed.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Vaccine given in upper most part of shoulder causing blood to spurt at site. Within in one hour, acute pain and loss of range of motion. Resulting in many physician appts, numerous physical therapy sessions and eventual shoulder surgery. PT appts continue post surgery. Company Incident Report filed on 10/8/15. Work comp claim filed.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Rash erythematous, Rash generalised, Rash maculo-papular, Rash pruritic
Clinical narrative: Patient developed a pruritic full body erythematous maculopapular rash the day after Hep A #2. Rash persisted for 5 days before I treated it with prednisone. Not otherwise ill.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a licensed practitioner nurse concerning an unknown number of patients of unknown age and gender. Since 19-MAR-2015 the patients were vaccinated with doses of improperly stored ROTATEQ, lot # K016261, expiration date 23-JUN-2016 (dose not reported), orally, which underwent support temperature excursions. This is one of several reports received from the same source. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Cold sweat, Dizziness, Nausea
Clinical narrative: Within the first 12 hrs. became nauseated all night. Went to church a few hours later and was severely dizzy, clammy and weak. Went to E.R. my blood pressure was 220/101 and I had already taken my regular blood pressure medicine. They had to give me another Bl. Press. med.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a female healthcare worker of unknown age, refers to herself. The patient's medical history and concurrent conditions and concomitant medications were not specified. On an unknown date, the patient was vaccinated with M-M-R II, as a child, (dose, frequency and route of administration not provided). Healthcare worker reported her titers showed low antibodies for MMR. The outcome of the event was not resolved. Causality assessment was not provided. No product quality complaint (PQC) was involved. No additional information was reported. Additional information is not expected, as the patient declined to answer questions.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 67 year old female patient. The patient's medical history included Knee replacement (right) (knee arthroplasty). There was no drug reactions or allergies reported. On 17-JUL-2015 the patient was vaccinated with ZOSTAVAX (lot # L011535, expiry date 03-JUL-2016) 0.65 ml, subcutaneously (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date approximately in July 2015 the patient experienced inflammation in her right knee (arthritis). It was reported that the patient sought medical attention and saw a physician who prescribed a MEDROL pack. No lab diagnostics studies were performed. The patient was treated with a MEDROL pack for the event. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of arthritis was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality complaint reported. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: Pt developed rash, beginning circular and then spread down to elbow. "Erythema, warm and raised." Pt treated with prednisone 5 mg 3 x daily for 3 days and then qd x 3 days.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information of this prospective pregnancy report has been received from a 23 year old female patient referring to herself. Concurrent condition and medical history were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (strength, lot #, expired date were unknown) intramuscularly. Then, the patient found out she was pregnant. The date of last menstrual period and the estimated date of delivery were not known. The pregnancy outcome was pending. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site paraesthesia, Injection site swelling
Clinical narrative: Patient noticed large, erythematous area of swelling that tingled on 8/5/15 around the injection site.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus, Rash, Swelling
Clinical narrative: Severe rash itching swelling spreading redness soreness. Doctor was unavailable went to ER.
Age: 36.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Myalgia, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Low grade fever (99 degrees F), muscle/body aches, shivering, swelling of vaccinated arm - all started a few hours after vaccination; no improvement with OTC naproxen and ice. Encouraged patient to follow-up with MD due to possible infection.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with improperly stored doses of VAQTA (lot # L009445, Exp. 01-JUN-2017, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Patient came back to pharmacy with big red welt at injection site. Her PCP looked at it and said it looked like the injection had been given SQ, not IM. Pharmacy RPH followed our standard protocol with injection in deltoid muscle with 1 inch needle. Patient given antibiotic by MD. Reaction not reported by patent at time of Administration.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from nurse practitioner via field employee referring to her daughter, a 13 year old female patient. Concurrent condition and medical history were not reported. ON an unspecified date in either February or March 2015, the patient was inadvertently administered a dose of GARDASIL (lot #, expired date and dose were unknown) subcutaneously (intramuscular formulation administered by other route) and (Oka/Merck) VARIVAX (lot #, expired date and dose were unknown) intramuscularly (subcutaneous injection formulation administered by other route). On an unspecified date in 2015, the reporter stated that her daughter experienced "a red, hot, super sore area 2 inches in diameter" at the GARDASIL injection site following the administration. The patient didn't seek medical attention but the reporter stated that she gave her daughter BENADRYL and applied ice to the site for treatment. No lab diagnostics studies were performed. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Diarrhoea, Irritability, Rash
Clinical narrative: Increased temp 102, irritable, rash, diarrhea. Onset at 1:30 pm. Child was seen in ER in the evening of 8/13/15 and was sent home.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 12-AUG-2015, the patient was vaccinated with VARIVAX (Merck), expired on 24-JUL-2015, (dose, frequency and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Puncture site reaction, Skin lesion
Clinical narrative: (L) upper arm with general erythema, 6" x 4" site, and crushed lesion at puncture site, also experienced chills.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: 8-11-15 4:22 pm KINRIX Dtap IPV Lot 3N7Y7 expiration 05/27/2017 manufacturer GlaxoSmithKline given (R) thigh IM. Pt was on antibiotic for ear infection at time of injection. Pt waited 10 minutes with no reaction. 8-13-15 4:40 pm pt came in with localized reaction at the injection site. Redness, raised area, warm to touch blotchy rash.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Rash macular
Clinical narrative: 8-11-15 4:22 pm KINRIX Dtap IPV Lot 3N7Y7 expiration 05/27/2017 manufacturer GlaxoSmithKline given (R) thigh IM. Pt was on antibiotic for ear infection at time of injection. Pt waited 10 minutes with no reaction. 8-13-15 4:40 pm pt came in with localized reaction at the injection site. Redness, raised area, warm to touch blotchy rash.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Cold sweat, Loss of consciousness, Pallor
Clinical narrative: He passed out while waiting 15min after receiving the vaccination. Pt. was pale and clammay.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt called pharmacy 8/11/15 & reported swelling and redness of arm where injection/vaccine provided. Pharmacist on duty reported called to vaccine provider on 8/13/15. Pt advised to see dr.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an hundred (unspecified) patients of unknown age and gender. NO pertinent medical history was reported. On an unknown date, the patients were vaccinated with GARDASIL (lot # K007264 and expiration date 02-MAR-2017) (dose and route were not reported) which were exposed to temperatures outside the recommended range. No adverse effects reported. No  Product Quality Complaint (PQC) was involved. This is one of two reports received from the same source. Additional information is not expected as the reporter was not receptive to follow up or contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 06-APR-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K003520 with expiration date of 20-NOV-2016; dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: On 8/10/15 - 19 day rash (L) upper arm, shoulder, chest shield since adm on 7/22/15. Area is expanding, warm, and pruritic.
Sex: U
Vaccine: PPV
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Information has been received from a consumer via Pfizer referring to a patient of unknown age or gender. The patient pertinent medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date, dose and frequency were unknown). On an unknown date the patient who received the pneumococcal conj vaccine (unspecified) after being vaccinated with PNEUMOVAX 23 experienced an Arthus reaction (reported as "an Arthus reaction"). The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a female patient of unknown age. No relevant medical conditions and drug allergies were reported. On 10-AUG-2015, the patient was inadvertently administered an expired dose of GARDASIL intramuscularly (lot # H011350, expiration date 21-FEB-2015, strength and dose were unknown), this was her first dose in the series. No adverse effects 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 nurse practitioner, and refers to an unspecified numbers of patient of unknown age and gender. Medical history and concurrent conditions were not reported. On unknown dates, the unspecified number of patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # J013394; expiration date on 25-AUG-2016, and K021444; expiration date on 17-SEP-2016 (strength, dose, anatomical location and route of administration were not provided). There was not concomitant medication reported. No adverse effects were reported. There was not a product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse practitioner referring to an unspecified number of patients of unknown age and gender. No concurrent or medical condition was reported. On an unknown date, 3 doses of improperly stored GARDASIL Lot # K011562, expiration date: 08-APR-2017, dose, route, frequency and anatomical location were not reported, were administered to unspecified number of patients. No concomitant medication was reported. No adverse event was reported. No further information was provided. No product quality complaint reported. This is one of several cases received from the same source (MARRS numbers 1508USA001815, 1508USA005093). 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 nurse practitioner, and refers to an unspecified numbers of patient of unknown age and gender. Medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of LIQUID PEDVAXHIB lot # K026533; expiration date on 07-AUG-2017(strength, dose, anatomical location and route of administration were not provided). There was not concomitant medication reported. No adverse effects were reported. There was not a product quality complain 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, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # L000456 exp date 06-JAN-2017) (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse via Poison and Drug Center (PDC) (MFR# US15-036291) referring to a patient of unknown gender, between the age of 2 years and 5 years old. The relevant medical history, past drug history and concomitant medication were unknown. The reporter stated the single-dose vial of PROQUAD (Merck) underwent temperature excursions as follows: on 26-MAY-2015, 5.3 degrees Celsius for 2 hours and 8 minutes. On 30-JUN-2015 the patient was vaccinated with the improperly stored PROQUAD (Merck) lot # K014798, expiration date: 12-MAR-2016 (strength and dose not reported). No adverse event was reported. This is one of the eight reports reported by the same Nurse. 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 licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored (Oka/Merck) VARIVAX (lot # L000456 exp date 06-JAN-2017) (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. 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 referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 20-APR-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K003520 with expiration date of 20-NOV-2016; dosage and route unspecified) (incorrect product storage). No adverse symptoms 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 from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # reported as L014401 exp date 23-OCT-2016) (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. 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 licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # reported as K020749 exp date 30-APR-2016) (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # reported as L003220 exp date 30-JUL-2016) (dose and route not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # reported as L003220 exp date 30-JUL-2016) (dose and route not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 11 year old male patient. Medical history and concurrent conditions were not reported. On 13-AUG-2015, the patient accidentally received a dose of LIQUID PEDVAXHIB lot number reported as L006545, expiry date 16-NOV-2017 (dose and route were not reported). There was no concomitant medication provided. The patient has not experienced any adverse effects at that time. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered Nurse referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 30-JUL-2015, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot # K010535, expiration date: 27-AUG-2016, dose, route, frequency and anatomical location were unknown. No adverse symptoms reported. No product quality complaint was reported. This is one of several cases received from the same source (MARRS number: 1508USA003819, 1508USA005117, 1508USA005118, 1508USA005119, 1508USA005120, 1508USA005121, 1508USA005123, 1508USA005124, 1508USA005125). Additional infomation has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered Nurse referring to a patient of unknown age and gender.No concurrent or historical condition was reported. On 29-JUL-2015, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB lot # K010535, expiration date: 27-AUG-2016, dose, route, frequency and anatomical location were unknown. No adverse symptoms reported. No product quality was reported. This is one of several cases received from the same source (MARRS numbers 1508USA003819, 1508USA005117, 1508USA005118, 1508USA005119, 1508USA005120, 1508USA005122, 1508USA005123, 1508USA005124, 1508USA005125). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown gender, between the age of 6 years and 12 years old. The patient's relevant medical history, past drug history, and concomitant medications were unknown. On 26-MAY-2015, the single-dose vial of (Oka-Merck) PROQUAD underwent temperature excursions as follows: 5.3 degrees Celsius for 2 hours and 8 minutes. On 30-JUN-2015, the patient was vaccinated with this (Oka-Merck) PROQUAD (strength and dose were unknown, route reported as injection, lot # K014798, expiration date 12-MAR-2016). Concomitant medications were unknown. It was unknown if there was any relevant laboratory data. At the time of reporting, it was unknown if the patient continued on (Oka-Merck) PROQUAD and the patient had not experienced any adverse events. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Patient's relevant medical history, concurrent conditions and drug reactions/allergies were not reported. On 15-JUL-2015, the patient was intended to be vaccinated with (Oka/Merck) VARIVAX, but was inadvertently administered with ZOSTAVAX (strength, dose, frequency, lot # unspecified). Concomitant medications were not reported. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an hundred (unspecified) patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with ROTATEQ (lot # K001198 and expiration date 25-OCT-2015) (dose and route were not reported) which were exposed to temperatures outside of the recommended range. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports received from the same source. Additional information is not expected as the reporter was not receptive to follow up or contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered Nurser referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 28-JUL-2015, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot # reported as l008660, expiration date: 10-NOV-2016, dose, route, frequency and anatomical location were unknown. No adverse symptoms reported. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers 1508USA003819, 1508USA005117, 1508USA005118, 1508USA005120, 1508USA005121, 1508USA005122, 1508USA005123, 1508USA005124, 1508USA005125). 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 registered nurse, referring to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date, unspecified number of patients were vaccinated with an improperly stored oral, ROTATEQ (strength, dose and frequency not reported) lot # L000425, expiry date 21-JUN-2016 and lot # K016261, expiry date 23-JUN-2016. No concomitant therapies were reported. No adverse effects were reported. This is one of three reports from the same source (MARRS linked cases 1508USA002613 and 1508USA004472). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered nurse referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 30-JUL-2015, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot # reported as L008660, expiration date: 10-NOV-2016, dose, route, frequency and anatomical location were unknown. No adverse symptoms reported. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers: 1508USA003819, 1508USA005117, 1508USA005118, 1508USA005119, 1508USA005121, 1508USA005122, 1508USA005123, 1508USA005124, 1508USA005125). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered Nurse referring to a patient of unknown age and gender. No concurrent or historiical condition was reported. On 03-AUG-2015, the patient was vaccinated with improperly stored dose of VAQTA 25/0.5 lot # L009445, expiration date: 01-JUN-2017, dose, route, frequency and anatomical location were unknown. No adverse symptoms reported. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers: 1508USA003819, 1508USA005117, 1508USA005119, 1508USA005120, 1508USA005121, 1508USA005122, 1508USA005123, 1508USA005124, 1508USA005125). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered Nurse referring to a patient of unkown age and gender. No concurrent or historical condition was reported. On 29-JUL-2015, the patient was vaccinated with improperly stored dose of VAQTA lot # K012457, expiration date: 04-JUN-2017, dose, route, frequency and anatomical location were unknown. No adverse symptoms reported. No product quality complaint was reported. This is one of several cases received from the same source (MARRS numbers: 1508USA005117, 1508USA005118, 1508USA005119, 1508USA005120, 1508USA005121, 1508USA005122, 1508USA005123, 1508USA005124, 1508USA005125). 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the unspecified patients were vaccinated with doses of VARIVAX (Merck), (strength, dose, frequency, route and anatomical location were not reported), (lot# L007225 with expiration date: 03-MAR-2017, and lot# reported as K018960 with expiration date: 15-OCT-2016), which were improperly storage. Other suspect and concomitant therapies were not reported. No adverse events were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a male patient of unknown age who was reporting on himself. Information regarding the patient's medical history, concurrent conditions or concomitant therapy was not provided. Approximately in 2006 (reported as "9 years ago"), the patient was vaccinated with ZOSTAVAX, subcutaneous injection (dose, lot number and expiration date were not provided). The patient reported that since an unknown date, since he was vaccinated, had been diagnosed with having a new case of shingles every year since the vaccination. Each time, he was treated in unspecified clinics with unspecified antiviral medications. At the time of this report, the outcome of shingles was unknown. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 03-JUL-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: L003855 and Expiry: 05-FEB-2017) (route unspecified). No adverse effect was 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 nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 01-JUL-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: L003855 and Expiry: 05-FEB-2017). No adverse effect was 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 nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 12-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of M-M-R II (lot: L003855 and Expiry: 05-FEB-2017) (route unspecified). No adverse effect was reported. This is one of the 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 a Nurse practitioner referring to an unspecified number of patients of unknown age and gender. No concurrent or medical condition was reported. On an unknown date, 7 doses of improperly stored M-M-R II Lot # K004949, expiration date: 04-APR-2016 and Lot # K020188, expiration date: 22-OCT-2016, dose, route, frequency and anatomical location were not reported, were administered to unspecified number of patients. No concomitant medication was reported. No adverse event was reported. No further information was provided. No product quality complaint reported. This is one of several cases received from the same source (MARRS numbers 1508USA001815, 1508USA005092). 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 patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 06-JUL-2015, the patient was vaccinated with unspecified number of improperly stored doses of M-M-R II (lot: K014833 and Expiry: 14-SEP-2016) (route unspecified). No adverse effect was reported. This is one of the 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 nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 07-JUL-2015, the patient was vaccinated with unspecified number of improperly stored doses of MMR II (lot: K014833 and Expiry: 14-SEP-2016) (route unspecified). No adverse effect was reported. This is one of the 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored (Oka/Merck) VARIVAX, lot number K007783, expiration date 28-MAY-2016 and lot number reported as L011084 expiration date 01-APR-2017, (dose and route were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports from the same source. 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. On unknown dates, the patients were vaccinated with doses of PROQUAD (Merck) (dose, route, lot # and expiration date were not provided) which were exposed to temperatures outside of the recommended range. No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Genital rash, Nausea, Penile pain, Penile swelling
Clinical narrative: ZOSTAVAX administered 8/4/15. 8/5/15 c/o nausea, dizziness, later that day pt reported fever of 104.8/6 pt reported fever of 102-seen by dr. 8/7 c/o penile swelling-seen by dr and urologist. Started pred pak. 8/10 c/o rash on penis. 8/11 still with swelling, pain, rash on pens-seen by urologist again. 8/14 pt states he about 50 % better.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: ZOSTAVAX administered 8/4/15. 8/5/15 c/o nausea, dizziness, later that day pt reported fever of 104.8/6 pt reported fever of 102-seen by dr. 8/7 c/o penile swelling-seen by dr and urologist. Started pred pak. 8/10 c/o rash on penis. 8/11 still with swelling, pain, rash on pens-seen by urologist again. 8/14 pt states he about 50 % better.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Exposure to communicable disease, Nausea, Penile swelling, Pyrexia
Clinical narrative: ZOSTAVAX administered 8/4/15. 8/5/15 c/o nausea, dizziness, later that day pt reported fever of 104.8/6 pt reported fever of 102-seen by dr. 8/7 c/o penile swelling-seen by dr and urologist. Started pred pak. 8/10 c/o rash on penis. 8/11 still with swelling, pain, rash on pens-seen by urologist again. 8/14 pt states he about 50 % better.
Sex: U
Vaccine: FLU4
Symptoms: Abdominal pain, Crying, Dyspepsia, Foetal exposure during pregnancy, Gastrooesophageal reflux disease
Clinical narrative: This prospective pregnancy case described the occurrence of heartburn in a neonate. the 30-year-old mother was a subject enrolled in an open label study: a prospective, exploratory, cohort study to detect and describe and abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX or FLUARIX QUADRIVALENT or FLULAVAL or FLULAVAL QUADRIVALENT during pregnancy or within 28 days preceding conception. The subject received Flu Seasonal QIV Dresden .5 ml on 26th September 2014. The mother's last menstrual period was on 23rd March 2014 and estimated date of delivery was 28th December 2014. The neonate was exposed to Flu Seasonal QIV Dresden at week 26 of gestation and during the second trimester of pregnancy. The neonate was diagnosed with heartburn. Additional event(s) included gastroesophageal reflux disease, crying, colic and maternal exposure during pregnancy, second trimester. The outcome of heartburn was recovered/resolved. The outcome(s) of the additional event(s) included gastroesophageal reflux disease (recovered/resolved), crying (recovered/resolved), colic (recovered/resolved) and maternal exposure during pregnancy, second trimester (unknown). It was unknown if the investigator considered the heartburn, gastroesophageal reflux disease, crying and colic to be related to Flu Seasonal QIV Dresden. See case US2015GSK002902 for details regarding the mother case. Additional details provided are as follows: The infant was fine initially, but after an unspecified time experienced heart burn, bad reflux, horrible crying and colic for the first 6 weeks of life. It was unspecified whether, the patient experienced colic or reflux.
Sex: U
Vaccine: HPV9
Symptoms: Presyncope
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of adolescent patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (strength, dose, route, lot# and expiration date unknown). After receiving GARDASIL 9, the patients experienced near syncope episodes. The reporter noted that most adolescent patients who had these episodes did not eat prior to injection and also received concomitant administration of other unspecified vaccination. The outcome of the event was unknown. Causality between event and GARDASIL 9 was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.36
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a patient of 4 months old of an unknown gender. The patient's relevant medical history and past drug history were unknown. On 14-APR-2010, the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route and lot # were unspecified). On 16-JUN-2010, the patient was vaccinated with the second dose of RECOMBIVAX HB (dose, route and lot # were unspecified). On 09-AUG-2010, the patient was vaccinated with the third dose of RECOMBIVAX HB (dose, route and lot # were unspecified). Concomitant medication were not reported. The reporter stated that the patient's dates of vaccination with RECOMBIVAX HB was not correct. No adverse experience reported. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 37 year (also reported as 38 year) old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 29-JUL-2015 at 11.30 am, the patient was vaccinated with PNEUMOVAX 23 (lot # K024976, expiry date 09-JUN-2016) intramuscular in the left arm. On 29-JUL-2015 at 1.00pm, the patient's left arm became red, swollen and warm to touch in an area of 12 centimeter by 12 centimeter around the injection site. The reaction was accompanied by soreness and pain. The patient said that the pain was "6 out 10" on the pain scale (1min-10 max). The patient was treated with TYLENOL and was asked to use ice packs. The outcome the events was unknown. The reporter did not provide the relatedness of the events with PNEUMOVAX 23. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On 06-APR-2015 the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (strength, dose, route, lot# and expiration date unknown). No adverse effects were reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. Follow up information has been received from the certified medical assistant on 06-AUG-2015 referring to the 12 (also reported as 16) months old female child. Pre-existing allergies, birth defects and medical conditions were not known. On 06-APR-2015 11:36 AM the patient vaccinated with the first dose of improperly stored (Oka/Merck) VARIVAX, (lot# K011804, expiration date was unknown) subcutaneously in the Left Vastus Lateralis (LVL), which was then recalled due to possible temperature compromise. The patient had no illness at time of vaccination. The patient was received with (Oka/Merck) VARIVAX on an unknown date of July 2015. Additional information is not expected as follow up information has been received. Patient information, product information and narrative were updated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender.No medical history or concurrent conditions were reported. On an unknown date, unspecified number of patients were vaccinated with an improperly stored GARDASIL (strength, dose, frequency and route of administration not reported) lot # J015378, expiry date 09-APR-2016 and lot # K007828, expiry date 02-MAR-2017. No concomitant therapies were reported. No adverse effects were reported. This is one of three reports from the same source.  Additional information has been requested.