chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: A report has been received from a Physician concerning a 2 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The patient experienced fever of 103-104F and bumpy rash/red rash on the body which started on 29-Oct-2014. The outcome of the event of fever of 103-104F and bumpy rash/red rash on the body is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Influenza, Influenza virus test positive, Pharyngitis streptococcal
Clinical narrative: A spontaneous report has been received from a pharmacist concerning a female patient. The patient's medical history and concomitant diseases not provided. Concomitant medications included oseltmivir. Patient had received FLUMIST QUADRIVALENT  2 sprays for LA/V. Pharmacist reported that patient took FMQ and seven days later patient got strep throat. Patient was treated for the flu and the results came back positive. The outcome of the events of strep throat and tested positive for flu were unknown. Reporter considered the events of strep throat and tested positive for to be non-serious.
Age: 17.0
Sex: F
Vaccine: FLUN3
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning a 17 year old, female subject, who had been receiving FLUMIST started on an unknown date. The patient experienced patient is pregnant. The outcome of the event patient is pregnant is unknown. The report was considered to be non-serious. The reporter considered that There was no casual relationship between patient is pregnant and FLUMIST. Based on the information in this report and awaiting the reporters assessment, the company physician considered the event of patient is pregnant suspect drug FLUMIST to be unrelated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare Worker refers to an unknown number of patients of unknown ages and gender. On an unspecified dates, since 06-FEB-2015, the patient were vaccinated with an inappropriate storage of ROTATEQ, (lot#, expiration date, route and dose were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Physician concerning a 6 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 02-Dec-2014. It was reported that patient received expired FLUMIST QUADRIVALENT which started on 02-Dec-2014. The outcome of the event of patient received expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 15.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza virus test positive, Oropharyngeal pain, Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning a 15 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 24-Sep-2014. The patient experienced tested positive for flu which started on 24-Nov-2014, fever and sore throat. The outcome of the event of fever and sore throat is unknown and at the time of reporting, the event of tested positive for flu was ongoing. The report was considered to be non-serious.
Age: 16.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a physician concerning a 16 year old, male subject who had been receiving FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on 03-Dec-2014. The reporter stated that we accidentally gave expired doses of FLUMIST to two patients which started on 03-Dec-2014. The outcome of accidentally gave expired doses of FLUMIST to two patients is unknown. The report was considered to be non-serious.
Age: 1.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a child, male subject, who had been receiving QLAIV (intranasal), 1 dose. Concomitant medications included flu shot. FLUMIST QUADRIVALENT started on 27-Nov-2014. The reporter who dispensed in a clinic setting the FLUMIST vaccine to the wrong patient population (under 2 years of age). The outcome of the event of wrongful administration is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between wrongful administration and QLAIV.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Decreased appetite, Influenza like illness, Malaise, Nasal congestion
Clinical narrative: A consumer report has been received. The report concerns a 6 year old. Female consumer, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 22-Nov-2014. The patient experienced coughing, didn't feel like eating, flu like symptoms, felt sick, nasal congestion and nose dripping which started on 22-Nov-2014. The patient recovered from the event of coughing, didn't feel like eating, flu like symptoms, felt sick, nasal congestion and nose dripping on 02-Dec-2014. The report was considered to be non-serious.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Rhinorrhoea
Clinical narrative: A consumer report has been received. The report concerns a 6 year old. Female consumer, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 22-Nov-2014. The patient experienced coughing, didn't feel like eating, flu like symptoms, felt sick, nasal congestion and nose dripping which started on 22-Nov-2014. The patient recovered from the event of coughing, didn't feel like eating, flu like symptoms, felt sick, nasal congestion and nose dripping on 02-Dec-2014. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a pharmacist concerning an adult, female subject who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 02-Dec-2014. Pharmacist administered FLUMIST on 02-Dec-2014 which had expired on 24-Nov-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 12 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced administered expired FLUMIST QUADRIVALENT which started on 26-Nov-2014. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 15.0
Sex: F
Vaccine: FLUN4
Symptoms: Swelling face
Clinical narrative: A report has been received from a health professional concerning a 15 year old, female patient. No medical history, concomitant diseases and concomitant medications were reported for consumer. Patient received FLUMIST QUADRIVALENT (intranasal) on November 20, 2014 and facial swelling was observed by parent the following morning on November 21, 2014. The outcome for the event of facial swelling was unknown. The report was considered to be non-serious by reporter.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza A virus test positive
Clinical narrative: A solicited report has been received from a Health professional concerning a patient of unknown gender and ethnicity. The relevant history and concomitant disease of the patient were not reported. The concomitant medications of the patient were not provided. Registered Nurse reported that a child received FLUMIST QUADRIVALENT (intranasal) in 2013-2014 season and tested positive for Flu A in Nov 2013. Action taken was not applicable for FLUMIST QUADRIVALENT. The outcome of the event of tested positive for flu A in Nov 2013 was unknown. The event tested positive for flu A in Nov 2013 considered to be non serious by the reporter. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event of tested positive for flu A in Nov 2013 with suspect drug FLUMIST QUADRIVALENT to be unrelated.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A solicited report has been received from a Health professional concerning a child patient, enrolled in a study. Patient relevant history, concurrent diseases and concomitant drugs were not reported. Patient had been receiving FLUMIST QUADRIVALENT (intranasal), started on 15-Oct-2014. The patient had influenza A on 21-Nov-2014. The outcome of the event of influenza A was unknown. The report was considered to be non-serious. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event influenza A to be not related to FLUMIST QUADRIVALENT.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza like illness
Clinical narrative: A spontaneous report has been received from a health professional concerning a 2 years old male patient. The patient's medical history, concurrent diseases and concomitant medication were not reported. On unspecified date, the patient had received FLUMIST QUADRIVALENT (intranasal) with unknown dose. It was reported that a child whose older sibling had the flu, then patient got FLUMIST QUADRIVALENT on the same day. Then within 48 hours, the patient started having flu like symptoms. The outcome of the event of older sibling had the flu, younger child got the flu like symptoms 48 hours after receiving FLUMIST was unknown. Reporter assesses the event of older sibling had the flu, younger child got flu like symptoms 48 hours after receiving FLUMIST to be non serious.
Age: 28.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: A report has been received from a Health Professional concerning a 28 year old, female subject who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 17-Nov-2014. The patient experienced pregnant patient got FLUMIST QUADRIVALENT which started on 17-Nov-2014. The outcome of the event of pregnant patient got FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 55.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 55 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced administered FLUMIST QUADRIVALENT to a 55 year old patient which started on 29-Nov-2014. The outcome of the event of administered FLUMIST QUADRIVALENT to a 55 year old patient is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza, Influenza like illness, Influenza virus test positive
Clinical narrative: A report had been received from the health professional concerning an 11 years male patient. The patient's medical history, concurrent disease and concomitant medications were not reported. It was report that patient received FLUMIST QUADRIVALENT (intranasal) on 27-Oct-2014. Patient returned to pediatrician's office with flu-like symptoms on 05-Nov-2014 and Flu test was negative then, returned on the 06-Nov-2014 and Flu test was positive. Patient was diagnosed with influenza. Patient was still symptomatic. At the time of reporting, the event of influenza was ongoing. The reporter considered the event of influenza to be serious.
Age: 41.0
Sex: F
Vaccine: FLUN4
Symptoms: Cold sweat, Diarrhoea, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: A consumer report has been received. The report concerns a 41 year old, female consumer, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 02-Oct-2014. The patient experienced loose stools, cold sweat, sinus infection and runny nose which started on 02-Oct-2014. The outcome of the event of loose stools, cold sweat and runny nose is unknown and at the time of reporting, the event of sinus infection was ongoing. The report was considered to be non-serious by the reporter. The company physician assessed the reported events of fever, productive cough, headache, body aches, sore throat and fatigue as symptoms of sinus infection.
Age: 41.0
Sex: F
Vaccine: FLUN4
Symptoms: Pain, Productive cough, Pyrexia, Rhinorrhoea, Sinusitis
Clinical narrative: A consumer report has been received. The report concerns a 41 year old, female consumer, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 02-Oct-2014. The patient experienced loose stools, cold sweat, sinus infection and runny nose which started on 02-Oct-2014. The outcome of the event of loose stools, cold sweat and runny nose is unknown and at the time of reporting, the event of sinus infection was ongoing. The report was considered to be non-serious by the reporter. The company physician assessed the reported events of fever, productive cough, headache, body aches, sore throat and fatigue as symptoms of sinus infection.
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. Patient received expired FLUMIST QUADRIVALENT which started on 04-Dec-2014. The outcome of the event of administration of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Pharmacist concerning a 12 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 01-Jan-2014. The reporter stated that the patient experienced expired FLUMIST QUADRIVALENT administered which started on 01-dec-2014. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report ws considered to be non-serious.
Age: 7.0
Sex: U
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A spontaneous report has been received from a pharmacist concerning a 7 years old patient of unknown gender. The patient's medical history and concomitant medications were not provided. Patient had received nasal FLUMIST (intranasal), unknown dose for unknown indication. Pharmacist reported that on 20-Nov-2014 patient had received the entire dose of FLUMIST in one nostril. The outcome of the event of full dose up one nostril was unknown. Reporter considered the event of full dose up one nostril to be non serious.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 02-Dec-2014. Ir as reported that patient ws administered by expired FLUMIST which started on 02-dec-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Body temperature increased, Influenza A virus test positive, Oropharyngeal pain, Pain, Respiratory tract congestion
Clinical narrative: A report has been received a from a Medical Rep concerning a, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. The patient experienced TESTED POSITIVE FOR A 103F TEMPERATURE, SORE THROAT, ACHES and CONGESTION which started on 23-Sep-2014. The outcome of the event of TESTED POSITIVE FOR A, 103F TEMPERATURE, SORE THROAT, ACHES and CONGESTION is unknown. The report was considered to be non-serious.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL) started on an unknown date. It was reported that there have been six breakthrough flu cases and all breakthrough patients tested positive for influenza A. The outcome of the event of MULITPLE PATIENTS TESTED POSITIVE FOR FLU A is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported for any of them. The reporter informed that on unknown dates, an unspecified number of patients were vaccinated with a dose of ROTATEQ Oral liquid, route defaulted to oral (dose number, batch/lot # and expiration date not reported). No adverse effects were reported. This is one of several reports coming from the same source. Additional information is not expected because neither the reporter nor the responsible physician wished to be contacted for further follow-up.
Age: 63.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving Nasal (INTRANASAL), 0.1 mL into each nostril for VACCINATION. FLUMIST (INTRANASAL) started on 06-Nov-2014 for VACCINATION. It was reported that patient had experiencing wrongful administration. The outcome of the event was WRONGFUL ADMINISTRATION is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between WRONGFUL ADMINISTRATION and QLAIV. The reporter and company physician considered the event of wrongful administration with the suspect drug of QLAIV to be unrelated.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Malaise, Vomiting
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal) 0.2 millilitrs, unknown. FLUMIST QUADRIVALENT (Intranasal) started on 27-Sep-2013. The patient experienced vomiting and received FLUMIST QUADRIVALENT last year and a few hours later was sick which started on 26-Sep-2013. The patient recovered from the event of vomiting and received FLUMIST QUADRIVALENT last year and a few hours later was sick on an unspecified date. The report was considered to be non-serious.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Abnormal behaviour, Decreased activity, Encephalitis, Laboratory test normal, Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to a 15 year old male patient. Patient's concurrent conditions and medical history was not known. On 10-NOV-2014, the patient was vaccinated with the first dose of GARDASIL injection and on 19-JAN-2015, patient received the second dose of GARDASIL, intramuscularly. Concomitant medications were not provided. On 22-JAN-2015, the patient experienced encephalitis (hospitalization, medically significant and life threatening). On that day, patient's parents stated that the patient was 'lying around', was not active and was not himself. On 23-JAN-2015, at 15:30 hours, the patient was found unconscious and unresponsive on his bedroom floor. The patient was taken to emergency room and was then hospitalized. Unspecified testing was conducted at that hospital. The patient had a follow up appointment with the physician who stated that the unspecified tests came back negative. The outcome of encephalitis was unknown. Causality assessment was not provided. The reporter considered encephalitis to be life threatening. Upon internal review, encephalitis was considered to be medically significant. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to a 15 year old male patient. Patient's concurrent conditions and medical history was not known. On 10-NOV-2014, the patient was vaccinated with the first dose of GARDASIL injection and on 19-JAN-2015, patient received the second dose of GARDASIL, intramuscularly. Concomitant medications were not provided. On 22-JAN-2015, the patient experienced encephalitis (hospitalization, medically significant and life threatening). On that day, patient's parents stated that the patient was 'lying around', was not active and was not himself. On 23-JAN-2015, at 15:30 hours, the patient was found unconscious and unresponsive on his bedroom floor. The patient was taken to emergency room and was then hospitalized. Unspecified testing was conducted at that hospital. The patient had a follow up appointment with the physician who stated that the unspecified tests came back negative. The outcome of encephalitis was unknown. Causality assessment was not provided. The reporter considered encephalitis to be life threatening. Upon internal review, encephalitis was considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a patient. Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 05-Dec-2014. The patient was given expired FLUMIST. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning an 11 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. It was reported that the patient experienced three patients inadvertently received FLUMIST QUADRIVALENT which started on 04-Dec-2014. The outcome of the event of three patients inadvertently received expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 60.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Pharmacist concerning a 60 year old, female subject, who had been receiving QLAIV (intranasal), 0.1mL into each nostril. FLUMIST QUADRIVALENT (intranasal) started on 23-Oct-2014. It was reported that pharmacist dispensed the FLUMIST vaccine to the wrong patient population which started on 23-Oct-2014. The outcome of the event of wrongful administration is unknown. The report was considered to be non-serious. The reporter and company physician considered that there was no causal relationship between wrongful administration and QLAIV.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown demographics. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, route and lot number were not reported). On an unknown date those patients experienced similar reactions of welts at the injection site after receiving ZOSTAVAX. The outcome and the causality assessment were not provided. This is one of several reports from the same source. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Blood culture negative, Blood lactate dehydrogenase normal, Blood thyroid stimulating hormone normal, Blood uric acid normal, Full blood count normal
Clinical narrative: Patient with febrile illness starting 6 days after vaccination. Nightly fever with myalgias for 6 nights, then improved. Patient did have blood work and urine studies done which were normal.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Metabolic function test normal, Mononucleosis heterophile test negative, Myalgia, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Patient with febrile illness starting 6 days after vaccination. Nightly fever with myalgias for 6 nights, then improved. Patient did have blood work and urine studies done which were normal.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Urine analysis normal
Clinical narrative: Patient with febrile illness starting 6 days after vaccination. Nightly fever with myalgias for 6 nights, then improved. Patient did have blood work and urine studies done which were normal.
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling
Clinical narrative: MMR and Varicella given on 2/24/15. On AM of 2/25 mom noted patient walking strangely as if legs wobbly - resolved Kw/in 1 1/2 hours. Patient later developed swelling and erythema (L) arm - upper exterior aspect 2" x 3".
Age: 0.3
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 4 month old patient of an unknown gender. Concurrent conditions, medical history and allergies were not reported. The reporter stated that on 13-FEB-2015, the patient was vaccinated with a dose of VAQTA 25/0.5 (units not provided), 0.5 ml, intramuscular, once instead of RECOMBIVAX HB. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a Registered Nurse concerning a female patient (age not reported) who on had received the 3rd dose series of RECOMBIVAX HB (dates, dose and site not reported) as routine vaccination. The Nurse reported that the patient "had titers drawn recently which showed a level of 5 which is not immune". No treatment was given. The patient was seen in the medical office. Relationship between Hepatitis B surface antibody negative and therapy with RECOMBIVAX HB was not reported. Additional information is not expected as no consent for follow up was obtained.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: This spontaneous report as received from a Registered nurse refers to a 8 year old patient with no pertinent medical history and no drug reactions/allergies. On 04-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 (dose unspecified) (lot # K007773 expiration date 01-MAY-2015), subcutaneous in the left arm. There were no concomitant medications. On 05-JAN-2015, therapy the patient experienced erythema, fever, swelling and pain, as well as a fever of 101F. The patient was seen an unspecified physician and was treated with MOTRIN. The outcome of injection site pain, injection site erythema, fever and injection site swelling was reported as recovering/resolving on an unknown date. No lab diagnostic studies were performed. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: This spontaneous report as received from a Registered nurse refers to a 8 year old patient with no pertinent medical history and no drug reactions/allergies. On 04-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 (dose unspecified) (lot # K007773 expiration date 01-MAY-2015), subcutaneous in the left arm. There were no concomitant medications. On 05-JAN-2015, therapy the patient experienced erythema, fever, swelling and pain, as well as a fever of 101F. The patient was seen an unspecified physician and was treated with MOTRIN. The outcome of injection site pain, injection site erythema, fever and injection site swelling was reported as recovering/resolving on an unknown date. No lab diagnostic studies were performed. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Tremor, Urinary tract infection
Clinical narrative: Pt c/o shaking and tremor in hands on 2/18/15 in the afternoon. Chest pain on 2/21/15. UTI-like sx's starting 2/21/15. Seen in urgent care and prescribed antibiotics with temporary relief. Sx's returned and patient went to urgent care for follow up.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling
Clinical narrative: Right deltoid swelling x 2-3 days. No treatment given.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown ages and genders. Since October 2014 the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (route, lot#, dose and frequency were unknown). No adverse effects were noted. It was unspecified if the patients sought medical attention. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unkonwn age. On unkown date in December 2013 the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration and lot # were not reported). It was reported that at the time of this report, the patient was scheduled to undergo a splenectomy for unknown reason on unknown date. The outcome of the event was unkonwn. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Dermatitis, Injection site erythema, Injection site pruritus
Clinical narrative: 2/17/15 - patient had redness and itching at injection site. 2/23/15 - seen in ER, diagnosed with cellulitis and dermatitis and given azithromycin.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a 49 male patient who was feeling sick reporting on himself. The patient was enrolled in a Patient Support Program. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (route, dose, lot # and expiration ate were not provided). On an unknown date, when the patient got the shot, the patient experienced malaise as he felt sick than before. At the time of the report the outcome of malaise was unknown. Additional information is not expected because the patient did not give his consent for follow-up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain in extremity, Rash, Rash macular
Clinical narrative: This spontaneous report as recovered from a 77 year old female patient with allergy to LEVAQUIN and penicillin (unspecified) refers to herself. The patient had no pertinent medical history. In approximately 2012 (reported as about 3 years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, lot#, route and site of administration were not reported). In approximately February 2015 (reported as last week), the patient noticed her right leg was getting sore and discovered a rash. In approximately February 2015 (reported as over the weekend), the rash evolved to splotchy stuff going down the right side of her right leg and blisters. The reporter stated that it looked like ring worm and was the size of a silver dollar. The patient also said that it looked like a "light case" compared to shingles pictures she saw. The patient sought medical attention. No lab diagnostics studies were performed. The patient was treated with methylprednisolone 4 mg dose pack, acyclovir 800 mg and methocarbamol 750 mg. The outcome of events was not reported. The relatedness between the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinea infection
Clinical narrative: This spontaneous report as recovered from a 77 year old female patient with allergy to LEVAQUIN and penicillin (unspecified) refers to herself. The patient had no pertinent medical history. In approximately 2012 (reported as about 3 years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, lot#, route and site of administration were not reported). In approximately February 2015 (reported as last week), the patient noticed her right leg was getting sore and discovered a rash. In approximately February 2015 (reported as over the weekend), the rash evolved to splotchy stuff going down the right side of her right leg and blisters. The reporter stated that it looked like ring worm and was the size of a silver dollar. The patient also said that it looked like a "light case" compared to shingles pictures she saw. The patient sought medical attention. No lab diagnostics studies were performed. The patient was treated with methylprednisolone 4 mg dose pack, acyclovir 800 mg and methocarbamol 750 mg. The outcome of events was not reported. The relatedness between the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Abnormal behaviour
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions were not reported. On an unknown date the patient was vaccinated with MMR II (dose, route of administration were not reported). The concomitant therapy included unspecified medication "A". The reporter stated that the patient, who she knew, acted differently after receiving a dose of MMR II. The outcome of the event was unknown. The causality between the event and MMR II was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling, Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, therapy route and vaccination schedule were not reported). On an unknown date the patient experienced shingles and swollen eye after receiving ZOSTAVAX. The outcome of shingles and swollen eye was unknown. The relatedness between the events and vaccination with ZOSTAVAX was not reported. 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 health professional refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported for any of them. The reporter informed that on unknown date, an unspecified number of patients were vaccinated with a dose of GARDASIL Intramuscular injection (dose number, route, anatomical location, batch/lot # and expiration date not reported). No adverse effects were reported. This is one of several reports coming from the same source. Additional information is not expected because neither the reporter nor the responsible physician wished to be contacted for further follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. Medical history and concurrent conditions were not reported. On 16-FEB-2015, these patients were vaccinated with improperly stored doses of ZOSTAVAX injection 19400 plaque forming units (PFU) (lot# K021953 with expiry date: 10-FEB-2016; strength, dose and route of administration unspecified). No co-suspect and concomitant therapies were reported. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse concerning two unspecified patients of unknown age and gender. Information about medical history and concurrent conditions was not reported. On an unknown date the patients were vaccinated with a dose of PNEUMOVAX 23, lot # K019386, expiration date 09-JUN-2016, (dose, frequency and route were not provided). Concomitant medications were not reported. On an unknown date the patients experienced redness, infection and swelling at the injection site. The reporting nurse requested a time sensitive lot check. The outcome of the events was unknown. The causal relationship between PNEUMOVAX 23 and the events was not provided. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a female child of unknown age. On 18-FEB-2015 (reported as "yesterday") the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB, 0.5 ml in her right thigh (lot# and route unspecified). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 4 month old patient of unknown gender. On 20-FEB-2015 the patient was vaccinated with (Oka/Merck) VARIVAX for prophylaxis at the age of 4 months. No adverse effect was reported. No product quality complaint (PQC) was reported for varicella virus vaccine live. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to an approximately 16 year old patient. On 11-FEB-2015 the patient was vaccinated with an improperly stored GARDASIL (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. No adverse event were reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Ear canal erythema, Ear pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Pain to right ear (stated); Right ear inner red and stated she had pain to her lymph nodes and that they were swollen. Also complained today 2/20/15 that lymph node under arm pit (Lt) is bigger.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Loss of consciousness
Clinical narrative: Coughing, lost consciousness for less than a minute, went to local ER. Recovered.
Age: 1.68
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Full blood count abnormal, Polymerase chain reaction, Pyrexia, Rash morbilliform
Clinical narrative: He had a classic measles rash and fever.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Culture throat, Dizziness, Headache, Influenza virus test, Pain
Clinical narrative: 102 degree fever, body aches, headache since 2/25/15 PM. Also felt dizzy. BP 118/70 T-97.1. R/O flu. R/O strep. pharyngitis. (P) cefdinir, TAMIFLU: Recheck 1 wk.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: 102 degree fever, body aches, headache since 2/25/15 PM. Also felt dizzy. BP 118/70 T-97.1. R/O flu. R/O strep. pharyngitis. (P) cefdinir, TAMIFLU: Recheck 1 wk.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, Local reaction, Swelling
Clinical narrative: Pt presented with a local reaction on 13Feb15. She stated it got bigger since her vaccine. The shot was given SQ instead of IM.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 10 x 16 cm pink/red area where injection was administered including itching and warmth. No open area. No vesicles or pustules. Normal arm movement and strength when evaled on 2/24/15 in office visit. Topical BENADRYL and hydrocortisone cream.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 10 x 12 cm erythema patch with central induration on right leg, no blisters.
Age: 1.07
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Febrile convulsion, Streptococcus test positive
Clinical narrative: Temp of 103 sometime after vaccines, presented to ER at 1833 with febrile seizure lasting approx. 1 minute.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Nuclear magnetic resonance imaging spinal normal, Pain, Rash, Spinal X-ray normal
Clinical narrative: This spontaneous report as received from over 65 year old male patient refers to himself. The patient's medical history was not reported. On an unknown date, afew years ago, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and site of vaccination were not reported). No concomitant medication was reported. On an unknown date, the patient experienced a mild outbreak on his right buttocks, small rash, internal shingles in the T10 vertebral area with severe pain throughout the left side and moving to the right side as well. Pain was excruciating and lasted for 6-8 weeks. The patient had Magnetic resonance imaging (MRI) and X-rays, there were no signs of stenosis or compression. No disc bulging of herniation ID. The outcome of event was reported as recovering. The patient could get out of bed and cough, laugh, sneeze. The relatedness between the event and ZOSTAVAX was not reported. A call was placed back to the consumer-an unspecified female consumer stated that the patient had "no idea what you're talking about, it must be someone else". Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown ages and gender. On 18-FEB-2015 the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot#, dosage and route unspecified). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, HPV4, MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning unspecified patient of unknown age and gender. On unknown dates, an unknown number of doses of improperly stored GARDASIL (lot# expiration date, strength, dose and route were not reported), RECOMBIVAX HB (lot# expiration date, strength, dose and route were not reported), PROQUAD (Merck) (lot# expiration date, strength, dose and route were not reported) and VARIVAX (Merck) (lot# expiration date, strength, dose and route were not reported) were inadvertently administered to unspecified patients. No adverse effects reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 19-FEB-2015 the patient was vaccinated with an expired dose of PNEUMOVAX23, 0.5 ml, intramuscular, lot# not reported, expiration date 29-JAN-2015. No adverse effect was reported at time of reporting. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two Licensed Practical Nurses referring to unspecified number of patients (age and gender were unknown). Information regarding concurrent conditions and medical history was not provided. On 09-JUL-2014, GARDASIL was improperly exposed to 10.9C for 17 hours. On unspecified dates after this, unspecified number of patients were vaccinated with doses of the improperly stored GARDASIL, intramuscularly (strength, dose, dose number and lot # were not reported). Concomitant therapy was not reported. No known adverse effects. This is one of several reports received from the same source. 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 nurse refers to unspecified number of patients of unknown gender. On an unknown date, unspecified number of patients were inadvertently vaccinated with Improperly stored LIQUID PEDVAXHIB. No adverse effect was reported. No product quality complaint (PQC) was reported for LIQUID PEDVAXHIB. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old male patient. In February 2015, reported as "last week", the patient was vaccinated with a dose of M-M-R II (dose, route, lot number and expiration date were not reported). In February 2015, after receiving M-M-R II, the patient experienced measles-like rash and fever spike. No treatment was given for the events. The patient's mom sough medical attention: she called the clinic. At the time of the report, the patient was recovering. Relatedness between the events and vaccination with M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two Licensed practical Nurses referring to unspecified number of patients (age and gender were unknown). Information regarding concurrent conditions and medical history was not provided. On 09-JUL-2014, M-M-R II was improperly exposed to 10.9C for 17 hours. On unspecified dates after this, unspecified number of patients were vaccinated with doses of the improperly stored M-M-R II, subcutaneously 9strength, dose, dose number and lot # were not reported). Concomitant therapy was not reported. No known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two Licensed practical Nurses referring to unspecified number of patients (age and gender were unknown). Information regarding concurrent conditions and medical history was not provided. On 09-JUL-2014, LIQUID PEDVAXHIB was improperly exposed to 10.9C for 17 hours. On unspecified dates after this, unspecified number of patients were vaccinated with doses of the improperly stored LIQUID PEDVAXHIB, intramuscularly (strength, dose, dose number and lot # were not reported). Concomitant therapy was not reported. No known adverse effects. This is one of several reports received from the same source. Additional information has been requested.