chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Eye swelling, Lip swelling, Rash generalised, Rash maculo-papular
Clinical narrative: Given MMR vaccine 3/3/15. Did well until 3/12/15 when rash appeared. Rash maculopapular, generalized, on exam 3/13/15. Per mother lower lip swollen, eyes swollen prior to BENADRYL shot 3/13/15.
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. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been concomitant.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent conditions and medical history were not provided. On 03-MAR-2015 the patient was vaccinated with GARDASIL (lot # K006191, expiration date 02-FEB-2017, dose, dose# and route not provided) after it was improperly stored. No adverse effects reported. The outcome of the events was not provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site inflammation, Injection site pain, Injection site reaction
Clinical narrative: Pt presented with abnormal redness and inflammation at injection site. Inflamed site was hot to the touch and pt complained of pain as well. Pt reported red border was continuing to expand and diameter at time of observation was about the size of a softball. Pt was advised to seek medical attention for possible infection. Pt returned after seeing a MD with a prescription for an anti-viral and an anti-biotic and was told she had shingles at the injection site by physician she was seen by.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Pt presented with abnormal redness and inflammation at injection site. Inflamed site was hot to the touch and pt complained of pain as well. Pt reported red border was continuing to expand and diameter at time of observation was about the size of a softball. Pt was advised to seek medical attention for possible infection. Pt returned after seeing a MD with a prescription for an anti-viral and an anti-biotic and was told she had shingles at the injection site by physician she was seen by.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Decreased appetite, Erythema, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site, inability to lift injected arm. Fever 100.6-101.8, loss of appetite, intermittent nausea, lethargy/malaise. Pain in deltoid, worsening erythema extending down deltoid to axillae. Day 3 and still symptomatic. Taking Acetaminophen for fever, ibuprofen for aches and pushing fluids. Tried warm compresses to affected area which did not help.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Lethargy, Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: Redness and swelling at injection site, inability to lift injected arm. Fever 100.6-101.8, loss of appetite, intermittent nausea, lethargy/malaise. Pain in deltoid, worsening erythema extending down deltoid to axillae. Day 3 and still symptomatic. Taking Acetaminophen for fever, ibuprofen for aches and pushing fluids. Tried warm compresses to affected area which did not help.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Redness and swelling at injection site, inability to lift injected arm. Fever 100.6-101.8, loss of appetite, intermittent nausea, lethargy/malaise. Pain in deltoid, worsening erythema extending down deltoid to axillae. Day 3 and still symptomatic. Taking Acetaminophen for fever, ibuprofen for aches and pushing fluids. Tried warm compresses to affected area which did not help.
Age: 11.0
Sex: F
Vaccine: DTAP, MEN
Symptoms: Activities of daily living impaired, Injection site pain, Pain in extremity, Pyrexia, Upper extremity mass
Clinical narrative: Severe arm pain at injection site as well arm. Fever 100.7. Pain affected ability to participate in usual activity, continues for 5 days and left large lump on arm.
Age: 3.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Juvenile idiopathic arthritis, Polymerase chain reaction, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Varicella eruption on V1 distribution on left face.  Was receiving immunosuppression at time of eruption (daily steroids and monthly canakinumab).  Admitted to the hospital and received IV acyclovir with resolution of symptoms and no resultant morbidity or mortality.  Admitted from 12/17/2014 to 12/24/2014.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Pain right shoulder, chills, neck pain, body aches.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Balance disorder, Discomfort, Mobility decreased
Clinical narrative: Extreme difficulty in rising from bed. Three hours later still very unsteady. By mid morning the unsteadiness was mostly gone. By evening all signs of discomfort were gone.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Ocular discomfort, Viral infection
Clinical narrative: PRESSURE BEHIND EYE ON THE SIDE OF THE INJECTION AND AND LATER DOUBLE VISION.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: Oral herpes
Clinical narrative: MY COLD SORES HEAL FASTER WITH VALACYCOVIR PO (VALTREX) AND DOCOSANOL (ABREVA) TOPICALLY.  USUALLY DON'T EVEN GET A COLD SORE NOW, JUST A PRODROMAL SIGN.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody increased, Arthralgia, Borrelia test negative, Immunology test normal, Joint swelling
Clinical narrative: Painful, swollen joints in middle fingers started on 11/19/2014. Migratory polyarthritis still affecting functioning: knees, shoulders, fingers, hands, neck, foot, toes, ankles.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Polyarthritis, White blood cell count normal
Clinical narrative: Painful, swollen joints in middle fingers started on 11/19/2014. Migratory polyarthritis still affecting functioning: knees, shoulders, fingers, hands, neck, foot, toes, ankles.
Age: 33.0
Sex: F
Vaccine: FLUX, HEP, HEPA
Symptoms: Clumsiness, Dysstasia, Ear infection, Influenza, Injection site swelling
Clinical narrative: The leg where her injections were given swelled to twice its normal size.  She screamed all night long, stopping only to vomit several times.  She had trouble standing, was clumsy and unresponsive at times. She woke the next morning thin, pale and lethargic. Afterword she had constant health issues (ear infections, colds, flu, staph - one following the next).  We worked with doctors, naturopaths, homeopaths and nutritionists to get her whole body healthy again.
Age: 33.0
Sex: F
Vaccine: FLUX, HEP, HEPA
Symptoms: Lethargy, Nasopharyngitis, Pallor, Screaming, Staphylococcal infection
Clinical narrative: The leg where her injections were given swelled to twice its normal size.  She screamed all night long, stopping only to vomit several times.  She had trouble standing, was clumsy and unresponsive at times. She woke the next morning thin, pale and lethargic. Afterword she had constant health issues (ear infections, colds, flu, staph - one following the next).  We worked with doctors, naturopaths, homeopaths and nutritionists to get her whole body healthy again.
Age: 33.0
Sex: F
Vaccine: FLUX, HEP, HEPA
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: The leg where her injections were given swelled to twice its normal size.  She screamed all night long, stopping only to vomit several times.  She had trouble standing, was clumsy and unresponsive at times. She woke the next morning thin, pale and lethargic. Afterword she had constant health issues (ear infections, colds, flu, staph - one following the next).  We worked with doctors, naturopaths, homeopaths and nutritionists to get her whole body healthy again.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Headache, Herpes zoster, Pain
Clinical narrative: Shingles symptoms-extreme pain, blistering, headache.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles symptoms-extreme pain, blistering, headache.
Age: 49.0
Sex: F
Vaccine: YF
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever, headache, aches & pains - took Advil and rested.  I felt much better the next day.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning to unspecified patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date, ROTATEQ was exposed to temperatures of 14.0 C for 4 hours and 30 minutes. At the time of the report if was unknown if the vaccine was applied to patients. This is one of several report 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 (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 29-DEC-2014, the patient was vaccinated with a dose of ROTATEQ, (strength, dose, route and anatomical location were not reported), (lot# J011336, expiration date: 14-MAY-2015), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2015 (reported as during the month of February 2015 vaccine exposed to 48 F) the patients were vaccinated with ROTATEQ (dose, lot number was unknown) which was improperly stored, exposed to 48 F for 26 days during the month of February 2015 (incorrect product storage). No adverse effects were reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. No further information was provided. This case linked several cases with the same reporter link. 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 (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 08-DEC-2014, the patient was vaccinated with a dose of oral, ROTATEQ, (strength, dose, route and anatomical location were not reported), (lot # J011336, expiration date: 14-MAY-2015), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 05-MAR-2015, the patient was vaccinated with an improperly stored M-M-R II (dose, strength, dose number, route af administration and lot number were not provided). No co-suspect or concomitant therapies were reported. Previous to administration, on an unspecified date, the vaccine was exposed to temperatures of 14.0 C for 4 hours and 30 minutes. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 09-MAR-2015, the patient was vaccinated with an improperly stored MMR II (dose, strength, dose number, route of administration and lot number were not provided). No co-suspect or concomitant therapies were reported. Previous to administration, on an unspecified date, the vaccine was exposed to temperatures of 14.0 C for 4 hours and 30 minutes. This is one of several reports from the same source. 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 concerning to 11 patients of unknown age and gender. No medical history or concurrent conditions were reported. In March 2015, the patients were vaccinated with improperly stored GARDASIL (dose, strength, dose number, route of administration and lot number were not provided). No co-suspect or concomitant therapies were reported. Previous to administration, on an unspecified date, the vaccines were exposed to temperatures to 14.0 C for 4 hours and 30 minutes. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 09-MAR-2015, the patient was vaccinated with an improperly stored M-M-R II (dose, strength, dose number, route ad administration and lot number were not provided). No co-suspect or concomitant therapies were reported. Previous to administration, on an unspecified date, the vaccine was exposed to temperatures of 14.0 C for 4 hours and 30 minutes. This is one of several reports from the same source. 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 healthcare worker (office manager) refers to a multiple unspecified patients of the unknown ages and genders who on an unknown dates were vaccinated with improperly stored GARDASIL (dose, lot #, expiration date and route were not reported). No adverse effects reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning to unspecified patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date, PROQUAD (Merck) was exposed to temperatures of -2.3 C for 4 hours and 20 minutes. At the time of the report, it was unknown if the vaccine was applied to patients. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: 4" red, swollen and warm rxn at site. Otherwise fine.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning to a patient of unknown age and gender. No medical or concurrent conditions were reported. On 05-MAR-2015, the patient was vaccinated with an improperly stored M-M-R II (dose, strength, dose number, route of administration and lot number were not provided). No co-suspect or concomitant therapies were reported. Previous to administration, on an unspecified date, the vaccine was exposed to temperatures of 14.0 C for 4 hours and 30 minutes. No adverse effect 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: Information has been received from a medical assistant concerning unspecified number of patients with unknown age and gender. No current or historical conditions were reported. On unspecified dates the patients were administered with doses of PROQUAD (Merck). This is one of several reports received from the same source (MARRS # 1503USA000906 and MARRS # 1503USA007020). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This spontaneous report as received form a pharmacist refers to a 61 year old female patient. The patient's concurrent condition and medical history was not reported. On 22-FEB-2015 at 15:00hr, the patient was vaccinated wit ZOSTAVAX (dose and site of administration not reported) Lot # K016322, subcutaneously. The patient also reported of soreness as recovered/resolved on 24-FEB-2015. The causality assessment was not provided. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin tightness, Urticaria
Clinical narrative: Patient received PREVNAR on 3/11/15. Reports next day her whole upper arm swollen (baseball size) and it is red. Her arm feels tight and she can see visible welt.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, refers to an unknown number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date, the patients were vaccinated with MMR II (strength, dosage, route, lot# and expiration date were not reported). That had been improperly stored. No adverse effects were reported. This is one of several case received from the same reporter. Additional information is not expected because the physician refused to be contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 22-DEC-2014, the patient was vaccinated with a dose of M-M-R II, (strength, dose, route and anatomical location were not reported), (lot # J013316, expiration date: 22-OCT-2016), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. No medical history and current conditions were reported. On unspecified dates in 2011 the patient received the first 2 doses of the GARDASIL (dose, route and lot # was unknown). On 10-MAR-2015 (reported as presently), the patient was in the office to receive his third dose (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint was involved. The outcome of the event was unknown. No further information was provided. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Joint range of motion decreased, Pain, Pruritus, Swelling
Clinical narrative: Information has been received from a 59 year old female patient concerning herself. The patient had allergic reaction with tetanus toxoid (dose, frequency and manufacturer were unspecified) and experienced swelling, soreness, limited range of motion and itchiness sometime in 1972. The patient had no pertinent medical history. On 09-FEB-2015 the patient was vaccinated with PNEUMOVAX 23 injection (dose, lot#, route and strength were not reported). The patient concomitantly (on 29-FEB-2015) received suspect therapy ZOSTAVAX injection (dose, strength, lot# and route were not reported), which was other-than-indicated in the prescribing information in the patient's left arm. After receiving PNEUMOVAX 23 the patient experienced swelling, soreness, limited range of motion and itchiness of her right arm from 10-FEB-2015. The patient also stated that she experienced the same adverse events with ZOSTAVAX. BENADRYL (dose, strength, frequency were not reported) was given as treatment for the adverse events. There were no lab diagnostics studies performed. The patient had sought medical attention via office visit on 13-FEB-2015. Outcome of the adverse events was reported as not recovered. Causality between the events and PNEUMOVAX 23 and ZOSTAVAX was not provided. 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 healthcare worker (office manager) refers to a multiple unspecified patients of the unknown ages and genders who on an unknown dates were vaccinated with improperly stored PEDVAXHIB (dose, lot #, expiration date and route were not reported). No adverse effects reported. It was unknown if the patents sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 05-MAR-2015, the patient was vaccinated with an improperly stored M-M-R II (dose, strength, dose number, route of administration and lot number were not provided). No co-suspect or concomitant therapies were reported. Previous to administration, on an unspecified date, the vaccine was exposed to temperatures of 14.0 C for 4 hours and 30 minutes. This is one of several reports 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 as received from a certified medical assistant refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored doses of ROTATEQ, oral (dose, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. 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 certified medical assistant refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning to a unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date, PEDVAXHIB was exposed to temperatures of 14.0 C for 4 hours and 30 minutes. At the time of the report, it was unknown if the vaccine was applied to patients. This is one of several reports from the same source. 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 medical assistant refers to an unspecified patients of unknown ages and genders who on an unknown dates were vaccinated with two improperly stored doses of VARIVAX (Merck) (dose, lot #, expiration date and route were not reported). No adverse events were reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. The patient's concurrent conditions or historical information was not reported. The medical assistant reported that over the last several years, an unknown number of patients have been administered doses PROQUAD (Merck) (frequencies, routes, lot numbers and expiration dates not reported) that have reached higher than recommended temperatures during the defrost cycling. No adverse effects reporting. This is one of two reports 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 health care worker refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2015 (reported as during the month of February 2015 vaccine exposed to 48 F) the patients were vaccinated with VAQTA (dose, lot number was unknown) which was improperly stored, exposed to 48 F for 26 days during the month of February 2015 (incorrect product storage). No adverse effects were reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. No further information was provided. This case is linked several cases with the same reporter link. 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, refers to an unknown number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date, the patients were vaccinated with ROTATEQ oral (strength, dosage, lot# and expiration date were not reported). That had been improperly stored. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information is not expected because the physician refused to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2015 (reported as during the month of February 2015 vaccine exposed to 48 F) the patients were vaccinated with GARDASIL (dose, lot number was unknown) which was improperly stored, exposed to 48 F for 26 days during the month of February 2015. No adverse effects were reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. No further information was provided. This case is linked several cases with the same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning to unspecified patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date, VARIVAX (Merck) was exposed to temperature of -2.3 C for 4 hours and 20 minutes. At the time of the report, it was unknown if the vaccine was applied to patients. This is one of several reports from the same source. 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 health care worker refers to an unspecified number of patients of unknown age and gender. The patients were vaccinated with RECOMBIVAX HB (dose, lot number was unknown) which was improperly stored, exposed to 48 F for 26 days during the month of February 2015. No adverse effects were reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. No further information was available. This is one of the several reports linked with the same reporter link. 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 healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 29-DEC-2014, the patient was vaccinated with a dose of GARDASIL, (strength, dose, route and anatomical location were not reported), (lot # K009482, expiration date: 06-MAR-2017), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PWC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a female patient of unknown age, regarding herself. No medical history and current conditions were reported. On an unknown date in 2011 (reported as 3 to 4 years ago) the patient was vaccinated with ZOSTAVAX (dose, lot number was unknown). No concomitant medications were reported. It was reported that on an unknown date the patient was in physician office for a schedule visit and the physician noticed a rash on her leg and diagnosed the rash as shingles. The outcome of the event shingles was reported as not recovered. The reporter causality was not provided. No further adverse event information was provided. 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 unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored doses of VAQTA (dose, route, lot number and expiry date were not reported). No adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. Her relevant medical history includes suffering an intra-parenchymal and subarachnoid hemorrhage and hospitalization in an Intensive Care Unit (ICU). Her relevant past drug history was unknown. On 28-FEB-2015, the patient was vaccinated with the first dose of PNEUMOVAX 23 in the right deltoid, lot number K018528 expiration date 14-APR-2016. Her relevant concomitant medications included PROTONIX and maintenance fluids. Two days later, on 02-MAR-2015, while being transferred from the ICU to the medical-surgical floor of the hospital, she was inadvertently given a second dose of PNEUMOVAX 23, the lot number and expiration date for the second dose was not known by the pharmacist. There was no relevant laboratory data. As of 02-MAR-2015, she no longer takes PNEUMOVAX 23 and the outcome of mistakenly being given a second dose of PNEUMOVAX 23 within two days of the first dose was unknown at the time of the report. 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 healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 13-JAN-2015, the patient was vaccinated with a dose of PEDVAXHIB, (strength, dose, route and anatomical location were not reported), (lot # J016186, expiration date: 24-OCT-2016), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. 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 unspecified patients of unknown age and genders who on an unknown dates were vaccinated with one improperly stored dose of PROQUAD (Merck) (dose, lot #, expiration date and route were not reported). NO adverse events were reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. 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 medical assistant refers to an unspecified number of patients of unknown demographics. The patients concurrent or historical conditions was not reported. The medical assistant reported that over the last several years, an unknown number of patients have been administered doses of VARIVAX (Merck) (frequencies, routes, lot numbers and expiration dates not reported) that have reached higher than recommended temperatures during the defrost cycling. No adverse effects 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: This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 02-JAN-2015, the patient was vaccinated with a dose of RECOMBIVAX HB, (strength, dose, route and anatomical location were not reported), (lot# reported as H5H4E, expiration date: 29-JAN-2016), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. 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 healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 22-DEC-2014, the patient was vaccinated with a dose of GARDASIL, (strength, dose, route and anatomical location were not reported), (lot # H020901, expiration date: 05-JUL-2015), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. 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 healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 29-DEC-2014, the patient was vaccinated with a dose of GARDASIL, (strength, dose, route and anatomical location were not reported), (lot # K009482, expiration date: 06-MAR-2017), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. 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 healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 07-JAN-2015, the patient was vaccinated with a dose of PEDVAXHIB, (strength, dose, route and anatomical location were not reported), (lot # J016186, expiration date: 24-OCT-2016), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. 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 healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 22-DEC-2014, the patient was vaccinated with a dose of GARDASIL, (strength, dose, route and anatomical location were not reported), (lot # K009482, expiration date: 06-MAR-2017), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filed. 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 as received from a registered nurse refers to an unspecified number of patients of unknown demographics. The patient's concurrent conditions or historical information was not reported. The registered nurse that six doses of GARDASIL 0.5 ml, intramuscularly, lot number K009202 expiration date 17-DEC-2016) (frequencies and routes not reported) that were exposed to temperatures outside of the recommended range were administered on unspecified dates in February 2015. No adverse effects reported. 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 unspecified number of patients with unknown age and gender. No current or historical conditions were reported. On unspecified dates the patients were administered with doses of VARIVAX (Merck) that underwent temperature excursion. No adverse experiences were reported. Outcome of the adverse event was unknown. The reporter considered the event to be not related to VARIVAX (Merck). This is one of several reports received from the same source (MARRS # 1503USA000906 and MARRS # 1503USA007019). 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, refers to an unknown number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date, the patients were vaccinated with RECOMBIVAX HB (strength, dosage, route, lot# and expiration date were not reported). That had been improperly stored. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information is not expected because the physician refused to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 29-DEC-2014, the patient was vaccinated with a dose of GARDASIL, (strength, dose, route and anatomical location were not reported), (lot # H020901, expiration date: 05-JUL-2015), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 05-DEC-2014, the patient was vaccinated with a dose of ROTATEQ, (strength, dose, route and anatomical location were not reported), (lot # J011336, expiration date: 14-MAY-2015), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 02-DEC-2014, the patient was vaccinated with a dose of M-M-R II, (strength, dose, route and anatomical location were not reported), (lot # J006995, expiration date: 14-JUN-2015), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 07-JAN-2015, the patient was vaccinated with a dose of M-M-R II, (strength, dose, route and anatomical location were not reported), (lot # J006995, expiration date: 14-JUN-2015), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 16-DEC-2014, the patient was vaccinated with a dose of M-M-R II, (strength, dose, route and anatomical location were not reported), (lot # J013316, expiration date: 20-OCT-2016), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. 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 registered nurse, refers to an unknown number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date, the patients were vaccinated with GARDASIL (strength, dosage, route, lot# and expiration date were not reported). That had been improperly stored. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information is not expected because the physician refused to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, refers to an unknown number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date, the patients were vaccinated with VAQTA (strength, dosage, route, lot# and expiration date were not reported). That had been improperly stored. No adverse effects were reported. This is one of several case received from the same reporter. Additional information is not expected because the physician refused to be contacted.
Age: 60.0
Sex: M
Vaccine: TD
Symptoms: Activities of daily living impaired, Chills, Myalgia, Pyrexia
Clinical narrative: Sore muscles in the evening. Worst the next day 03//14/2015- with chills, fevers, sore muscles all over, stay in bed with banket. I was unable to meet my obligations.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site pain, Muscle spasms, Muscular weakness
Clinical narrative: Injection at 12:30PM, 4PM Acute severe Right deltoid pain, constant, weakness of arm, unable to move right arm. 5pm pain continues along with spasms. Treated with NSAID/ICE. MD appointment the following day, diagnostic imaging and Vicodin and Motrin prescribed. Off of work due to inability to move arm. MRI pending.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Nuclear magnetic resonance imaging, X-ray limb
Clinical narrative: Injection at 12:30PM, 4PM Acute severe Right deltoid pain, constant, weakness of arm, unable to move right arm. 5pm pain continues along with spasms. Treated with NSAID/ICE. MD appointment the following day, diagnostic imaging and Vicodin and Motrin prescribed. Off of work due to inability to move arm. MRI pending.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site reaction, Mobility decreased, Myalgia, Nuclear magnetic resonance imaging
Clinical narrative: Injection at 12:30PM, 4PM Acute severe Right deltoid pain, constant, weakness of arm, unable to move right arm. 5pm pain continues along with spasms. Treated with NSAID/ICE. MD appointment the following day, diagnostic imaging and Vicodin and Motrin prescribed. Off of work due to inability to move arm. MRI pending.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Activities of daily living impaired, Injection site pain, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Received Flu shot and pneumonia shot shortly before discharge.  I felt pain when the pneumonia shot was administered and within a day or two the pain got worse and I am still in pain in my left arm. Pain is severe most of the time; I have difficulty sleeping due to the pain.  I have difficulty moving arm; especially when I am showering I can't move my arm across my body to wash my right side.  I can not sleep on my left side as the pain gets worse.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain, Pain in extremity
Clinical narrative: Received Flu shot and pneumonia shot shortly before discharge.  I felt pain when the pneumonia shot was administered and within a day or two the pain got worse and I am still in pain in my left arm. Pain is severe most of the time; I have difficulty sleeping due to the pain.  I have difficulty moving arm; especially when I am showering I can't move my arm across my body to wash my right side.  I can not sleep on my left side as the pain gets worse.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Sleep disorder
Clinical narrative: Received Flu shot and pneumonia shot shortly before discharge.  I felt pain when the pneumonia shot was administered and within a day or two the pain got worse and I am still in pain in my left arm. Pain is severe most of the time; I have difficulty sleeping due to the pain.  I have difficulty moving arm; especially when I am showering I can't move my arm across my body to wash my right side.  I can not sleep on my left side as the pain gets worse.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscle atrophy, Myalgia
Clinical narrative: Shortly after vaccine in left arm-muscle was in extreme pain and later atrophied. Patient is seeing her doctor for this.