chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 28 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 23 months old child patient of unknown gender. On 23-JUN-2014 the patient was vaccinated with a dose of PEDVIXHIB (dose and route were not reported, lot# J015437, expiration date 09-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Age: 1.1
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 month old patient (gender not reported). On 09-JUL-2014 the patient was vaccinated with M-M-R II (HSA) lot # H010134, 0.5 ml, subcutaneous that expired on 17-MAY-2014. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Wheelchair user
Clinical narrative: This spontaneous report was received from a Journalist refers to a female patients of unknown age. On an unknown date, the patients were vaccinated with GARDASIL (dose, route and lot # were not reported). On an unknown date, the patients experienced unspecified adverse effects that have left them wheelchair bound, after receiving GARDASIL. The outcome of unspecified adverse effects that have left them wheelchair bound was unknown. This is one report of several reports from the same source (MARRS # 1408USA001063). This case was considered medically significant due to patient disabling. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pruritus, Rash, Urticaria
Clinical narrative: Rash-hives around neck, itching, slight nausea.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Mobility decreased, Pain
Clinical narrative: Got my flu shot on 10/2, sore a couple days.  Woke up on Saturday AM and couldn't move arm.  Warm, swollen, and red in area of flu shot on my shoulder.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Face injury
Clinical narrative: Became dizzy and lightheaded while at check out bumping his chin on the counter, placed in chair, put on exam table vital signs taken, ice applied no apparent injury, denies complaints. Left in ten minutes after same.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Patient states that she developed a rash on her arms, chest and back later that evening after receiving vaccines. Provider looked at rash and prescribed medicaiton to take for the itching.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Aphagia, Aphasia, Blood test, Computerised tomogram, Deformity
Clinical narrative: Finally diagnosed as Miller-Fisher Guillain-Barre Syndrome -Facial paralysis affecting: Vision, unable to make tears and eye muscle rigidness (unable to blink). Nasal passage obstruction due to cartilage not having tone and flat. Hearing affected due to receptor paralysis. Dietary affected by being unable to bite, swallow, or chew appropriately.  Communication limited, unable to annunciate.  Disfigurement and low self concept. Aug. 2 is month 10.  Improvement is occurring, albeit very slowly.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Guillain-Barre syndrome, Hypoacusis, Mastication disorder, Miller Fisher syndrome
Clinical narrative: Finally diagnosed as Miller-Fisher Guillain-Barre Syndrome -Facial paralysis affecting: Vision, unable to make tears and eye muscle rigidness (unable to blink). Nasal passage obstruction due to cartilage not having tone and flat. Hearing affected due to receptor paralysis. Dietary affected by being unable to bite, swallow, or chew appropriately.  Communication limited, unable to annunciate.  Disfigurement and low self concept. Aug. 2 is month 10.  Improvement is occurring, albeit very slowly.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Nasal obstruction, Nuclear magnetic resonance imaging, Oculofacial paralysis, Self esteem decreased, VIIth nerve paralysis
Clinical narrative: Finally diagnosed as Miller-Fisher Guillain-Barre Syndrome -Facial paralysis affecting: Vision, unable to make tears and eye muscle rigidness (unable to blink). Nasal passage obstruction due to cartilage not having tone and flat. Hearing affected due to receptor paralysis. Dietary affected by being unable to bite, swallow, or chew appropriately.  Communication limited, unable to annunciate.  Disfigurement and low self concept. Aug. 2 is month 10.  Improvement is occurring, albeit very slowly.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Visual impairment
Clinical narrative: Finally diagnosed as Miller-Fisher Guillain-Barre Syndrome -Facial paralysis affecting: Vision, unable to make tears and eye muscle rigidness (unable to blink). Nasal passage obstruction due to cartilage not having tone and flat. Hearing affected due to receptor paralysis. Dietary affected by being unable to bite, swallow, or chew appropriately.  Communication limited, unable to annunciate.  Disfigurement and low self concept. Aug. 2 is month 10.  Improvement is occurring, albeit very slowly.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Fever: 101.8. Redness, swelling, induration to injection sites (right deltoid, left arm). TX: Per mother prescribed antibiotics.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Syncope
Clinical narrative: Syncope and seizure.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported, 1 single shot, subcutaneous). Concomitant therapy was not reported. On an unknown date the patient experienced shingles after receiving ZOSTAVAX. The outcome of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. On 01-AUG-2014 the patient was inadvertently vaccinated with an expired dose of MMR II subcutaneously (lot # H013040, Expiration Date: 17-JUL-2014) (dose was not reported). No adverse effects were reported. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 86 year old male patient. Medical history and concurrent conditions were not reported. On 31-JUL-2014, the patient was vaccinated with ZOSTAVAX, 0.75 ml, subcutaneous. Lot number and expiration date were not reported. The pharmacist reported that another pharmacist administered ZOSTAVAX to the patient. Patient's daughter called Pharmacist on 04-AUG-2014 initially stating that she believed her father may had received ZOSTAVAX 10 years ago, but as the phone call went on Pharmacist reports that patient's daughter said she was not sure when or if her father received the vaccine prior to the dose administered on 31-JUL-2014 and she would be called her father's Physician to find out. Pharmacist would call back with more information if patient had actually received the vaccine twice. No other information available. No adverse effects noted to patient. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored PNEUMOVAX 23 (dose, lot # and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknwon date the patients were vaccinated with an improperly stored ROTATEQ oral (dose and lot # were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored RECOMBIVAX HB (dose, lot # and route of administration were not reported). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Eyelid irritation, Glossodynia, Paraesthesia
Clinical narrative: This spontaneous report as received from a physician refers to a 71 year old female patient with heartburn, allergic to amoxicillin and allergic to tetanus vaccine. On 30-JUL-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Lot number and expiration date were not reported. Concomitant therapies included PEPCID. The physician reported that a patient developed "burning and tingling" around her eye, on both sides of her face, tongue and the base of her neck the day after receiving ZOOSTAVAX (on 31-JUL-2014). The patient reported to the physician that she felt like she had a rash. The physician reported that a pink area was noted at the base of the neck. The outcome of adverse events was reported as not recovered/not resolved. The patient did seek medical attention. The physician had started the patient on hydroxyzine. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 71 year old female patient with heartburn, allergic to amoxicillin and allergic to tetanus vaccine. On 30-JUL-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Lot number and expiration date were not reported. Concomitant therapies included PEPCID. The physician reported that a patient developed "burning and tingling" around her eye, on both sides of her face, tongue and the base of her neck the day after receiving ZOOSTAVAX (on 31-JUL-2014). The patient reported to the physician that she felt like she had a rash. The physician reported that a pink area was noted at the base of the neck. The outcome of adverse events was reported as not recovered/not resolved. The patient did seek medical attention. The physician had started the patient on hydroxyzine. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored PEDVAXHIB (dose, lot # and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored VAQTA (dose, lot # and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored GARDASIL (dose, lot # and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner referring to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patient received improperly stored MMR II [lot # J010993/ expiry date 13-SEP-2015] exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with the cases 1407USA012136, 1407USA014425, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner referring to patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 23-JUL-2014 the patient received improperly stored with MMR II [lot # J10993 expiry date 13-SEP-2015], exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with cases 1407USA012136, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of GARDASIL (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner referring to patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 22-JUL-2014 patient received improperly stored MMR II, [lot# J010933/exp. date 09/06/2015) exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner referring to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 21-JUL-2014 patient received improperly stored MMR II [lot # J010993/ exp. date 09/06/2015] exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with the cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner referring to patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 22-JUL-2014 patient received improperly stored MMR II [J010993/ exp. date 09/06/2015], exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000009, 1408USA000012, 1408USA0000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 24-JUL-2014 patient received improperly stored MMR II [lot # J010993/ exp. date 09/06/2015], exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner referring to patients of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patients received improperly stored VAQTA, exposed to 8.4 degree for 20 minutes, intramuscular (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with the cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner referring to patients of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patients received improperly stored ROTATEQ, exposed to 8.4 degree for 20 minutes and also to temperature of 9.7 degree for 6 hours 20 minutes, oral (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with the cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000848 and 1408USA000853. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner referring to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. on 21-JUL-2014 patient received improperly stored MMR II [lot # J010993/ exp. date 09/06/2015] exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with the cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner referring to patients of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patients received improperly stored GARDASIL, exposed to 8.4 degree for 20 minutes and also to temperature of 9.7 degree for 6 hours 20 minutes, intramuscular (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner referring to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. on 21-JUL-2014 patient received improperly stored MMR II [lot # J010993/ exp. date 09/06/2015] exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with the cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner referring to patients of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patients received improperly stored PNEUMOVAX 23 exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with the cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, and 1408USA000853. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner referring to patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 22-JUL-2014 patient received improperly stored MMR II [LOT # J009382/ exp. date 08/08/2015], exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with cases 1407USA012136, 1407USA104425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner referring to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. on 22-JUL-2014 patient received improperly stored MMR II [lot # J009382/ exp. date 08/08/2015] exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with the cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 9 month old patient. No concurrent conditions or medical history were provided. On 09-JUL-2014, the 9 month old patient was vaccinated with the first dose of PROQUAD (Merck) injection (dose, route of administration, indication, lot# and expiry date unspecified). No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a 66 year old registered nurse referring to herself. The patient had no drug reactions/allergies. Pertinent medical history was none. Concurrent conditions were not reported. On 11-JUL-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot # J013135, expiry date: 17-JAN-2015) 0.65 ml, subcutaneous. Concomitant therapy included SYNTHROID. On 11-JUL-2014, the patient experienced redness, swelling and pain around injection site. No laboratory tests were performed. The patient sought medical attention, had called up to the physician's office. The patient was treated with ibuprofen. The outcome of redness, swelling and pain around injection site was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant (healthcare worker) regarding an unspecified number of patients. The patients demographics were unknown. There was no pertinent medical history and drug reaction or allergies of the patients reported. On unspecified dates, an unspecified number of patients were vaccinated with RECOMBIVAX HB (dose, route, product lot and expiry date was not provided) that might had been improperly stored. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 1.27
Sex: M
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 15 months old infant patient of unknown gender. On 20-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effect were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a patient of unknown age and gender. It was reported that on 19-JUN-2013 the patient was vaccinated with a first dose of RECOMBIVAX HB 10mcg/ml (dose 1ml intramuscularly: lot number not provided), on 07-JUN-2014 the patient was vaccinated with a second dose of RECOMBIVAX HB 10mcg/ml (dose 1ml intramuscularly; lot number not provided). A third dose of RECOMBIVAX HB had not been given on 17-JUL-2014 (reported "as of today"). No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Vomiting
Clinical narrative: Pt tried getting up after 5 mins of vaccine admin. Felt dizziness and vomiting. Subsided after 15 mins.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Inflammation, Pain, Pruritus, Rash
Clinical narrative: Swelling, inflamed, sore, itching, spreading rash. Treated at ER on 8/2/14. Discharge diagnosis: Allergic Reaction (unclear if cellulitis) IV antibiotic administered. Prescribed Keflex 500mg 4/day for 7 days. Prescribed Prednisone 40mg for 4 days.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling, inflamed, sore, itching, spreading rash. Treated at ER on 8/2/14. Discharge diagnosis: Allergic Reaction (unclear if cellulitis) IV antibiotic administered. Prescribed Keflex 500mg 4/day for 7 days. Prescribed Prednisone 40mg for 4 days.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Adverse drug reaction, Cellulitis, Erythema, Mass, Swelling
Clinical narrative: States 4 weeks after receiving vaccine she noticed a large red area (size of a baseball) with a marble size round lump inside.  Very tender to the touch.  Went to a provider 3 days after symptoms started, was dx with cellulitis put on an antibiotic, states has a reaction to that medication was only on it a few days and stopped it and then was never put back on an antibiotic as the swelling and redness went away.  Currently still has a small marble size lump with in her skin that she can feel.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Tenderness
Clinical narrative: States 4 weeks after receiving vaccine she noticed a large red area (size of a baseball) with a marble size round lump inside.  Very tender to the touch.  Went to a provider 3 days after symptoms started, was dx with cellulitis put on an antibiotic, states has a reaction to that medication was only on it a few days and stopped it and then was never put back on an antibiotic as the swelling and redness went away.  Currently still has a small marble size lump with in her skin that she can feel.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Dizziness, Fall, Pallor
Clinical narrative: Pts father states that pt fell at parking lot after left clinic. Pt c/o dizziness noted color pale. Offered apple juice. After that pt said feel better. BP 124/72 HR 77 alert orinted x4. Pt want go home refuse to go ugrent care. Advise to go URGENT CARE if condition gets worsen. Pt left clinic with father.
Age: 1.5
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter state that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration date not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 18 months old infant patient of unknown gender. On 19-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 1.52
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 18 months old infant patient of unknown gender. On 17-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot # J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Age: 1.41
Sex: M
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 16 months old infant patient of unknown gender. On 17-JUN-2014 the patient was vaccinated with a dose of PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effect were reported. This is the one of several reports received from the same reporter. Additional information is not expected.
Age: 36.0
Sex: M
Vaccine: HIBV
Symptoms: Back pain, Bacteraemia, Bacterial test positive, Blood culture positive, Central venous catheterisation
Clinical narrative: Information has been received from the authors in a published literature article. A 36 year old male with history of acute lymphoblastic leukemia status post bone marrow transplant (BMT), in remission and on no immunosuppressive medications, presented the emergency department for evaluation of syncope in the context of several days of fever, productive cough and dyspnea, gradual onset of headache, diffuse back pain and a few loose stools. He was treated presumed community-acquired pneumonia but progressively became more tachypneic, hypotensive and developed altered mental status requiring intubation, central line placement and vasopressors. He was admitted to the ICU under these conditions. The blood cultures were positive for gram negative bacillus and the lumbar puncture was indicative of bacterial meningitis. Bacterial speciation of the cultures confirmed the pathogen was Haemophilus influenza. The patient had successful immunization post BMT, as confirmed by serology. The final diagnoses for this patient were invasive Haemophilus influenza (serotype A) with meningitis, bacteremia and presumed sinusitis with susceptibility to Haemophilus influenza secondary to previously undiagnosed functional hyposplenism. Haemophilus influenza is a pleomorphic, non-motile, facultative anaerobic gram-negative coccobacillus and a human-specific pathogen. There are encapsulated (typeable) and unencapsulated (nontypeable) strains. Prior to the development of the vaccine, the capsule was thought to be the primary virulence factor, with serotype B being the predominant strain causing clinical disease. Therefore, serotype B is the target of immunizations against Haemophilus influenza. The epidemiology of invasive disease has shifted after widespread, vaccination, with nontypeable strains causing the majority of invasive infections in all age groups. Despite the common belief that immunizations have eliminated Haemophilus influenza from authors differential diagnoses, in the post vaccine era, the most common presentations of invasive Haemophilus influenza are bacteremia and meningitis. Both encapsulated (non-serotype B) and unencapsulated strains can lead to invasive disease, therefore it is imperative that physicians recognize that, in the case of Haemophilus influenza, immunization does not equal eradication. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: HIBV
Symptoms: Diarrhoea, Dyspnoea, Endotracheal intubation, Gram stain negative, Haemophilus infection
Clinical narrative: Information has been received from the authors in a published literature article. A 36 year old male with history of acute lymphoblastic leukemia status post bone marrow transplant (BMT), in remission and on no immunosuppressive medications, presented the emergency department for evaluation of syncope in the context of several days of fever, productive cough and dyspnea, gradual onset of headache, diffuse back pain and a few loose stools. He was treated presumed community-acquired pneumonia but progressively became more tachypneic, hypotensive and developed altered mental status requiring intubation, central line placement and vasopressors. He was admitted to the ICU under these conditions. The blood cultures were positive for gram negative bacillus and the lumbar puncture was indicative of bacterial meningitis. Bacterial speciation of the cultures confirmed the pathogen was Haemophilus influenza. The patient had successful immunization post BMT, as confirmed by serology. The final diagnoses for this patient were invasive Haemophilus influenza (serotype A) with meningitis, bacteremia and presumed sinusitis with susceptibility to Haemophilus influenza secondary to previously undiagnosed functional hyposplenism. Haemophilus influenza is a pleomorphic, non-motile, facultative anaerobic gram-negative coccobacillus and a human-specific pathogen. There are encapsulated (typeable) and unencapsulated (nontypeable) strains. Prior to the development of the vaccine, the capsule was thought to be the primary virulence factor, with serotype B being the predominant strain causing clinical disease. Therefore, serotype B is the target of immunizations against Haemophilus influenza. The epidemiology of invasive disease has shifted after widespread, vaccination, with nontypeable strains causing the majority of invasive infections in all age groups. Despite the common belief that immunizations have eliminated Haemophilus influenza from authors differential diagnoses, in the post vaccine era, the most common presentations of invasive Haemophilus influenza are bacteremia and meningitis. Both encapsulated (non-serotype B) and unencapsulated strains can lead to invasive disease, therefore it is imperative that physicians recognize that, in the case of Haemophilus influenza, immunization does not equal eradication. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: HIBV
Symptoms: Haemophilus test positive, Headache, Hypotension, Intensive care, Lumbar puncture abnormal
Clinical narrative: Information has been received from the authors in a published literature article. A 36 year old male with history of acute lymphoblastic leukemia status post bone marrow transplant (BMT), in remission and on no immunosuppressive medications, presented the emergency department for evaluation of syncope in the context of several days of fever, productive cough and dyspnea, gradual onset of headache, diffuse back pain and a few loose stools. He was treated presumed community-acquired pneumonia but progressively became more tachypneic, hypotensive and developed altered mental status requiring intubation, central line placement and vasopressors. He was admitted to the ICU under these conditions. The blood cultures were positive for gram negative bacillus and the lumbar puncture was indicative of bacterial meningitis. Bacterial speciation of the cultures confirmed the pathogen was Haemophilus influenza. The patient had successful immunization post BMT, as confirmed by serology. The final diagnoses for this patient were invasive Haemophilus influenza (serotype A) with meningitis, bacteremia and presumed sinusitis with susceptibility to Haemophilus influenza secondary to previously undiagnosed functional hyposplenism. Haemophilus influenza is a pleomorphic, non-motile, facultative anaerobic gram-negative coccobacillus and a human-specific pathogen. There are encapsulated (typeable) and unencapsulated (nontypeable) strains. Prior to the development of the vaccine, the capsule was thought to be the primary virulence factor, with serotype B being the predominant strain causing clinical disease. Therefore, serotype B is the target of immunizations against Haemophilus influenza. The epidemiology of invasive disease has shifted after widespread, vaccination, with nontypeable strains causing the majority of invasive infections in all age groups. Despite the common belief that immunizations have eliminated Haemophilus influenza from authors differential diagnoses, in the post vaccine era, the most common presentations of invasive Haemophilus influenza are bacteremia and meningitis. Both encapsulated (non-serotype B) and unencapsulated strains can lead to invasive disease, therefore it is imperative that physicians recognize that, in the case of Haemophilus influenza, immunization does not equal eradication. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: HIBV
Symptoms: Meningitis bacterial, Mental status changes, Pneumonia, Productive cough, Pyrexia
Clinical narrative: Information has been received from the authors in a published literature article. A 36 year old male with history of acute lymphoblastic leukemia status post bone marrow transplant (BMT), in remission and on no immunosuppressive medications, presented the emergency department for evaluation of syncope in the context of several days of fever, productive cough and dyspnea, gradual onset of headache, diffuse back pain and a few loose stools. He was treated presumed community-acquired pneumonia but progressively became more tachypneic, hypotensive and developed altered mental status requiring intubation, central line placement and vasopressors. He was admitted to the ICU under these conditions. The blood cultures were positive for gram negative bacillus and the lumbar puncture was indicative of bacterial meningitis. Bacterial speciation of the cultures confirmed the pathogen was Haemophilus influenza. The patient had successful immunization post BMT, as confirmed by serology. The final diagnoses for this patient were invasive Haemophilus influenza (serotype A) with meningitis, bacteremia and presumed sinusitis with susceptibility to Haemophilus influenza secondary to previously undiagnosed functional hyposplenism. Haemophilus influenza is a pleomorphic, non-motile, facultative anaerobic gram-negative coccobacillus and a human-specific pathogen. There are encapsulated (typeable) and unencapsulated (nontypeable) strains. Prior to the development of the vaccine, the capsule was thought to be the primary virulence factor, with serotype B being the predominant strain causing clinical disease. Therefore, serotype B is the target of immunizations against Haemophilus influenza. The epidemiology of invasive disease has shifted after widespread, vaccination, with nontypeable strains causing the majority of invasive infections in all age groups. Despite the common belief that immunizations have eliminated Haemophilus influenza from authors differential diagnoses, in the post vaccine era, the most common presentations of invasive Haemophilus influenza are bacteremia and meningitis. Both encapsulated (non-serotype B) and unencapsulated strains can lead to invasive disease, therefore it is imperative that physicians recognize that, in the case of Haemophilus influenza, immunization does not equal eradication. Additional information has been requested.