chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Activities of daily living impaired, Chills, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report was received from an office manager/healthcare worker and refers to a 54 years old female patient with BACTRIM, amoxicillin and LEVAQUIN allergy. The patient's medical history included breast cancer. On 02-JUN-2015, the patient was vaccinated with PNEUMOVAX23 (0.5ml, intramuscularly, left arm, lot number: K022886, expiry date: 09-JUN-2016). Concomitant therapies included tramadol hydrochloride, FLONASE and PROZAC. In approximately June 2015, after receiving PNEUMOVAX23, the patient experienced pain in her left arm, itching (unspecified area) (PT: pruritus), nausea, swelling (unspecified area) and a spotty rash on her torso, right arm and both legs (PT: rash). No lab test diagnostic was performed. The patient was seen by a physician in the office on an unspecified date and the physician prescribed BENADRYL, ZYRTEC and MEDROL DOSEPAK. At the time of the report, the patient was a little better (recovering). The relatedness between the therapy with PNEUMOVAX23 and the adverse event was not reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Pain, Rash generalised
Clinical narrative: This spontaneous report was received from an office manager/healthcare worker and refers to a 54 years old female patient with BACTRIM, amoxicillin and LEVAQUIN allergy. The patient's medical history included breast cancer. On 02-JUN-2015, the patient was vaccinated with PNEUMOVAX23 (0.5ml, intramuscularly, left arm, lot number: K022886, expiry date: 09-JUN-2016). Concomitant therapies included tramadol hydrochloride, FLONASE and PROZAC. In approximately June 2015, after receiving PNEUMOVAX23, the patient experienced pain in her left arm, itching (unspecified area) (PT: pruritus), nausea, swelling (unspecified area) and a spotty rash on her torso, right arm and both legs (PT: rash). No lab test diagnostic was performed. The patient was seen by a physician in the office on an unspecified date and the physician prescribed BENADRYL, ZYRTEC and MEDROL DOSEPAK. At the time of the report, the patient was a little better (recovering). The relatedness between the therapy with PNEUMOVAX23 and the adverse event was not reported. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP, HPV4, PNC13, RV1, HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 4 month old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 12-JUN-2015, the patient was inadvertently vaccinated with a dose of GARDASIL (lot number, dose and route were not reported), instead of hib conj vaccine. No occurrence of product confusion was reported. No adverse effect was reported. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP, HPV4, PNC13, RV1, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 4 month old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 12-JUN-2015, the patient was inadvertently vaccinated with a dose of GARDASIL (lot number, dose and route were not reported), instead of hib conj vaccine. No occurrence of product confusion was reported. No adverse effect was reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Vaccination site induration
Clinical narrative: Patient was not evaluated by me, but emailed to report that approximately 24h after being vaccinated, she began to notice redness, itching, egg size lump and induration on the area where she had received the vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site induration
Clinical narrative: Left upper thigh with small area of induration but no tenderness to the proximal region of the side that was demarcated with sharpie. No erythema. No lymphadenopathy.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Culture negative, Injection site erythema, Injection site haemorrhage, Lumbar puncture normal, Pyrexia
Clinical narrative: Significant redness around the vaccines sites with positive erythema/edema in lower legs and feet. These symptoms resolved and petechial developed below the knees only.  Pt was admitted for a complete sepsis workup.  Pt was febrile on day one of admission but remained afebrile afterwards.  All cultures and Lumbar puncture were negative at 48 hrs.  Pt was discharged and followed up with PCM.  Pt's mom was advised one vaccine at a time unless otherwise indicated or recommended.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vaccination site oedema
Clinical narrative: Significant redness around the vaccines sites with positive erythema/edema in lower legs and feet. These symptoms resolved and petechial developed below the knees only.  Pt was admitted for a complete sepsis workup.  Pt was febrile on day one of admission but remained afebrile afterwards.  All cultures and Lumbar puncture were negative at 48 hrs.  Pt was discharged and followed up with PCM.  Pt's mom was advised one vaccine at a time unless otherwise indicated or recommended.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Rash started at neck and traveled down torso to legs and feet; fever reached 101.5; gave Tylenol and rash went away on its own.
Age: 0.64
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Diarrhoea, Pyrexia, Rash, Vomiting
Clinical narrative: MOM CALLED AND STATED THAT CHILD HAD A FEVER OF 102.5, RASH ON TORSO, DIARRHEA AND VOMITING WITH LAST IMMS ON 6/9/15. ALSO STATES THAT HAD THE SAME REACTION THE PREVIOUS TIME BEFORE WHEN IMMS WERE ADMINISTERED ON 5/12/15. S/SX OCCURRED 4-5 DAYS AFTER SHOTS AND MOM FELT CHILD WAS REALLY SICK. NOTIFIED PEDS DOCTOR.
Sex: U
Vaccine: HIBV
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 age and gender. No information regarding the patients pertinent medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated with doses of LIQUID PEDVAXHIB (dose, frequency, route of administration, lot# and expiry date unspecified) which were improperly stored. No concomitant medication was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ orally, lot # K013868, expiry date: 27-MAY-2016, and lot # reported as: K017573 and expiry date: 11-JUN-2016 (dosage not provided). 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
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. On 26-MAY-2015 the patient was vaccinated with one dose of RECOMBIVAX HB (dose and route of administration were not reported, lot # K008988 with expiration date 04-FEB-02016), which was improperly stored. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with GARDASIL (lot number reported as L007531 and expiration date 04-NOV-2016) dose, frequency and route of administration were not provided, which on an unknown date underwent a temperature excursion. No adverse effects were experienced by any of the patients. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia, Diplopia, Headache, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a medical assistant referring to a 12 year old male patient with none pertinent medical history or drug reactions/allergies. The patient was vaccinated with his first dose, second and third dose of GARDASIL (first dose: lot# J009243, expire date: 23-APR-2016; second dose: lot # J012212, expire date: 18-FEB-2016; third dose: lot# J015378, expiration date: 09-APR-2016), intramuscularly (dose unknown) on 31-OCT-2013, 03-JAN-2014 and 07-MAY-2014, respectively. Concomitant therapies included CLARITIN. On 29-JUN-2014, the patient experienced double vision, headaches, and unspecified joint pain "for three days" prior to visiting the physician (02-JUL-2014). A magnetic Resonance Imaging (MRI) was performed on an unspecified date on which "something" was seen. This caused the patient to be referred to the emergency room. From there, the patient was admitted to the hospital, where he was diagnosed with multiple sclerosis on an unspecified date. The double vision, headaches, and joint pain resolved without any specific treatment, and patient was discharged from the hospital on an unspecified date. The patient was just being watched for now in regard to the multiple sclerosis. The relationship of the multiple sclerosis and GARDASIL was not reported. Upon internal review, multiple sclerosis was considered to be medically significant. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Induration, Nodule, Tenderness, Upper extremity mass
Clinical narrative: A 25-year-old male, 2 weeks status post anthrax administration the right deltoid, complains of firm painful nodule that he noticed one to 2 days ago. Exam demonstrates an approximately 3 cm superior to inferior firm, fixed, tender nodule/mass over the belly of the deltoid, moves slightly with deltoid activation.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Warm red raised area, 2"x2", itched. Used Benadryl, applied several times a day for a week.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Blood potassium decreased, Brain natriuretic peptide increased, Cardiomegaly, Chest X-ray abnormal, Dyspnoea
Clinical narrative: Palpitations, dyspnea worsening, and worsening edema of lower legs.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Echocardiogram abnormal, Left atrial dilatation, Oedema peripheral, Palpitations, Pleural effusion
Clinical narrative: Palpitations, dyspnea worsening, and worsening edema of lower legs.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Pulmonary hypertension
Clinical narrative: Palpitations, dyspnea worsening, and worsening edema of lower legs.
Sex: U
Vaccine: RV5
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 age and gender. On an unknown date, the patients were vaccinated orally with ROTATEQ, (lot number reported as K002939 and expiration date 16-JAN-2016; lot number K007244 and expiration date 16-MAR-2016) dose and frequency were not provided, which, on an unknown date, underwent temperature excursion. No adverse effects were experienced by any of the patients. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. On 26-MAY-2015 the patient was vaccinated with one dose of PNEUMOVAX 23 (dose and route of administration were not reported, lot # L003188 with expiration date 06-JUL-2016), which was improperly stored. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse, refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were inadvertently vaccinated with ROTATEQ orally (lot #, expiration date and dose were not reported), that had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected, because there was no consent to contact a physician.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with an unspecified number of doses of ROTATEQ, orally (dose, frequency and lot# were not reported), which were improperly stored. Information regarding concomitant medications was not reported. No adverse experiences were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck), (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Follow up information has been received on 18-MAY-2015 and on 19-MAY-2015 from the reporting medical assistant and the physician, respectively. The physician provided information regarding the patients identifiers, lot number and date of vaccination. It was reported that the patient was vaccinated with an improperly stored dose of VARIVAX (Merck), lot number K015970 on 24-MAR-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to 30-40 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (0.5 ml, subcutaneously, lot # K013867 with expiration date 05-MAR-2016, lot # K005647 with expiration date 17-OCT-2016 and lot # K009197 with expiration date 27-DEC-2015). No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected as the reporter did not grant permission to contact them or physician.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Impetigo, Rash vesicular, Varicella virus test positive
Clinical narrative: Information has been received from a nurse referring to a 14 year old male patient. The patient had drug reactions/allergies to amoxicillin. The patient had no concomitant medication or pertinent medical history. The patient completed a two-dose series of (Oka/Merck) VARIVAX subcutaneously for varicella vaccination; his first dose of (Oka/Merck) VARIVAX (lot #640073/11146L, exp 14-FEB-2003) was administered in his right arm on 13-MAR-2002 at age 12 months old; his second dose of (Oka/Merck) VARIVAX (lot# was reported as 1781A, exp 11-DEC-2010) was administered in his left arm on 24-MAR-2009 at age 8 years old. Patient developed a vesicular rash on his left mid-flank axillary area an unspecified number of days prior to visiting an urgent care clinic on 07-JUN-2015. Patient was referred to his primary physician, who suspected either impetigo or shingles, so treatment was initiated with topical mupirocin and oral acyclovir. On an unknown date of June 2015, the physician scraped a sample of a vesicle and sent it for varicella-zoster virus "antigen direct fluorescent antibody stain (AG DFA)" testing, which came back positive, confirming a diagnosis of shingles. Treatment with both mupirocin and acyclovir was continued to prevent further bacterial infection of the rash. The outcome of the event was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Follow up information has been received on 18-MAY-2015 and on 19-MAY-2015 from the reporting medical assistant and the physician, respectively. The physician provided information regarding the patients identifiers, lot number and date of vaccination. It was reported that the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX, lot number K015970 on 30-MAR-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 15-JUN-2015, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot number, dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to currently 4 year old child patient of unknown gender. No information about medical history, concurrent conditions was reported for the patient. On 23-APR-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose in series unspecified) lot# K010440, expiration date 22-JUL-2016, 0.5 ml, once subcutaneously for routine vaccination. No adverse effects reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to the case 1506USA007776 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot#, expiration date, dose and route not reported). No adverse events were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with an unspecified number of doses GARDASIL (dose, frequency, route and lot# were not reported), which were improperly stored. No adverse experiences were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to currently 4 year old child patient of unknown gender. No information about medical history, concurrent conditions was reported for the patient. On 22-APR-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose in series unspecified) lot # K005427, expiration date 15-APR-2016, 0.5 ml, once subcutaneously for routine vaccination. No adverse effects reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to the case 1506USA007806 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with an unspecified number of doses PNEUMOVAX 23 (dose, frequency, route and lot # were not reported), which were improperly stored. Information regarding concomitant medications was not reported. No adverse experiences were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to 30-40 patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses (Oka/Merck) VARIVAX (0.5 ml, subcutaneously, lot # K007973, expiration date 03-JUN-2016). No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected as the reporter did not grant permission to contact them or physician.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a less than 55 years old adult female patient (the patient is 60 years old at the reporting time). Information regarding relevant medical history and concurrent condition were not reported. On an unknown date, when ZOSTAVAX first came out, the patient was vaccinated with ZOSTAVAX (dose, route, lot # not reported). At that time, the patient was less than 55 years old. No adverse symptoms 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 (Medical Assistant) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. The health professional reported that on 26-MAY-2015, the patient was vaccinated with the third dose of improperly stored GARDASIL intramuscular injection (strength, dose and lot number or batch number unspecified). The details of administration of the first and second dose of GARDASIL were not informed. No concomitant medications were reported. No adverse experience was reported. Product quality complaints (PQC) involved was reported as Yes. The outcome of the events was unknown. The reporter's causality for the events was not provided. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored doses (Oka/Merck) VARIVAX (0.5 ml, subcutaneously, lot # K011085, expiration date 08-AUG-2016). No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected as the reporter did not grant permission to contact them or physician.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored doses of GARDASIL (lot#, expiration date, dose and route not reported). No adverse events were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose, frequency, route of administration, lot# and expiry date unspecified) which were improperly stored. No concomitant medication was reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse, refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were inadvertently vaccinated with M-M-R II (lot #, expiration date, dose and route were not reported), that had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected, because there was no consent to contact a physician.
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of an unknown age and gender. The patient's current conditions and medical history were not reported. On 25-OCT-1999, the patient was already vaccinated with PNEUMOVAX23 injection (unknown strength, route and dose). On 29-MAY-2015, the patient was supposed to get vaccinated with PREVNAR 13 but instead was vaccinated with PNEUMOVAX23 by a "floating" nurse. The outcome of the event was unknown. There was no product quality complaint involved. Additional information is not expected as no healthcare professional contact details were provided.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # K016965, expiry date: 20-JUL-2017, and lot # reported as: K025002 and expiry date: 20-JUL-2017 (dosage and route not provided). 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
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse, refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were inadvertently vaccinated with RECOMBIVAX HB (lot #, expiration date, dose and route were not reported), that had been improperly stored. No adverse effects reported. This is one of several reported received from the same source. Additional information is not expected, because there was no consent to contact a physician.
Sex: U
Vaccine: HEPA
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 age and gender. On an unknown date, the patients were vaccinated with pediatric doses of (lot number K012457 and expiration date 04-JUN-2017; lot number reported as K014696 and expiration date 11-NOV-2015; lot number L001627 and expiration date 11-NOV-2015) dose, frequency and route of administration were not provided, which, on an unknown date, underwent a temperature excursion. It was also reported that some patients received pediatric dose and some received adult dose of VAQTA. No adverse effects were experienced by any of the patients. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: This spontaneous report was received from a female consumer of unknown age who was reporting on herself. The patient's medical history included herpes zoster (twice). The patient's concurrent conditions and concomitant medications were not reported. In October or November 2014 (date unspecified), the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous; dose, lot # and expiration date were not reported). In May 2015 (reported as around the first week of May 2015), the patient contracted shingles. The patient had the rush that "hurts and itches terribly" on her face and scalp. The patient sought an unspecified type of medical attention. The patient received the treatment with ibuprofen and other unspecified medication. None lab diagnostics studies were performed.  The outcome of the adverse event was report as recovering. The relatedness between the adverse event and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Injection site pain, Syncope
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified number of patients (also reported as: "3 out of every 10 patients) of unknown age and gender. Concomitant medication, pertinent medical history, drug reactions or allergies were not provided. On an unknown date, unspecified number of patients were vaccinated with GARDASIL 9 (dose, route of administration, lot #, expiration date - not reported). On an unknown date, the patients experienced injection site pain followed by fainting when received GARDASIL 9. The adverse events occurred while the patients were in the office. The outcome of events was unknown. The relatedness between the event and GARDAISL 9 was not reported. No other details were provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a patient of unknown gender and age. On 27-MAY-2015 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (Lot # K018144; expiration date: 10-APR-2016). No adverse effect was reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: IPV, MMRV, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented to the clinic on 6-11-15 with redness, swelling and tenderness at injection site of MMRV vaccine.  Right upper posterior arm has an area of erythema 3 inches in diameter that is tender to the touch.  Patient was diagnosed with secondary cellulitis by PA-C and treated with Keflex 500 mg three times a day for 7 days.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site swelling, Injection site warmth, Pruritus, Upper respiratory tract infection
Clinical narrative: Left arm became hot and swollen 3 inches above and below the injection site. Moderate itching and swelling worsened over course of days.  Swelling lasted for over 3 weeks. Several upper respiratory infections over next months and extended fatigue.
Sex: U
Vaccine: HEP
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 age and gender. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (lot number J012520 and expiration date 30-JAN-2016; lot number reported as K009505 and expiration date 07-FEB-2016; lot number K006366 and expiration date 24-OCT-2016) dose, frequency and route of administration were not provided, which, on an unknown date, underwent a temperature excursion. No adverse effects were experienced by any of the patients. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. On 26-MAY-2015 the patient was vaccinated with one dose of PNEUMOVAX23 (dose and route of administration were not reported, lot # L003188 with expiration date 06-JUL-2016), which was improperly stored. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 20 unspecified patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of an improperly stored ROTATEQ (lot #, expiration date and dose were not reported), route default as oral. Secondary suspects and concomitant therapies were not reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent to contact Health Care Professional was given.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Syncope, Tremor
Clinical narrative: Several minutes after HPV vaccine was administered, pt's dad reports a syncopal episode with "loss of consciousness and shaking of arms and legs". Patient was awake and alert when this nurse arrived on scene (Patient was in his dad's car). He was oriented but "lightheaded" and diaphoretic. He was placed in Trendelenburg position in the car and transported to the E.R.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent to contact Health Care Professional was given.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The concurrent condition and medical history was not reported. Approximately in December 2014 (reported as 5 or 6 months ago) the patient was vaccinated with GARDASIL dose 1 (route unspecified). Other suspect therapy included DEPO-PROVERA. The concomitant medications were not reported. It was reported that the patient went to the office on 11-JUN-2015 (reported as today) to receive the second dose of GARDASIL. Vaccine however, the patient was inadvertently administered with a dose of DEPO-PROVERA instead of GARDASIL. Vaccine on an unspecified date. It was also reported that the patient was receiving the second dose of GARDASIL. Vaccine late. No adverse event was reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to an unspecified number of patients of unknown demographics. Medical history and concurrent conditions were not reported. On an unknown date, unspecified number of patients were vaccinated with VARIVAX (Merck) (dose, route of administration, anatomical location and lot# was unknown) which were stored improperly. Concomitant medications were unspecified by reporter. No adverse effects and product quality complaint was reported. The outcome of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information is not expected as reporter was not willing to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates the patients were vaccinated with GARDASIL (lot#, expiration date, dose, route not reported), which were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates the patients were vaccinated with PNEUMOVAX 23 (lot#, expiration date, route not reported), which were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 4 year old male patient. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K004860 and expiration date 04-OCT-2015 also reported as 10-APR-2016) (dose and route were not reported). No adverse effects reported at that time. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates the patients were vaccinated with ROTATEQ (lot#, expiration date and dose not reported), orally, which were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. The patients were vaccinated with improperly stored ZOSTAVAX (dose, route unspecified) on 19-MAY-2015, 02-JUN-2015, 04-JUN-2015, 05-JUN-2015 and 08-JUN-2015. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates the patients were vaccinated with VAQTA (lot#, expiration date, dose and route not reported), which were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 5 year old female patient. No pertinent medical history was reported. On 10-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K004860 and expiration date 04-OCT-2015 also reported as 10-APR-2016) (dose and route were not reported). No adverse effects reported at that time. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to a child of unknown age and gender. On 05-JUN-2015, the patient was accidentally vaccinated with ZOSTAVAX (route of administration, dose, lot number and expiry date were not reported). The patient was prescribed VARIVAX (Merck). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates the patients were vaccinated with RECOMBIVAX HB (lot#, expiration date, dose and route not reported), which were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to an unspecified number of patients of unknown demographics. Medical history and concurrent conditions were not reported. On an unknown date, unspecified number of patients were vaccinated with PROQUAD (Merck) (dose, route of administration, anatomical location and lot# was unknown) which were stored improperly. Concomitant medications were unspecified by reporter. No adverse effects and product quality complaint was reported. The outcome of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information is not expected as reporter was not willing to be contacted.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Pain in extremity
Clinical narrative: STARTED HAVING SEVERE PAIN IN LEGS.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Muscle spasms, Pain, Pain in extremity
Clinical narrative: Pt came to office on 6/12/15 for DM follow-up and PA ordered pneumococcal conjugate vaccine 13-valent (Prevnar 13) IM vaccine. Vaccine given at 1110. Within 2 hours after receiving the vaccine, pt started experiencing left arm pain described as throbbing and stated pain 10/10 in intensity.  Pt returned to the office on 6/15/2015.  Pt had c/o left upper arm tenderness and muscle spasm.  On exam, there was no redness, warmth or fevers associated.
Age: 18.0
Sex: F
Vaccine: FLUX, HPVX
Symptoms: Exposure during pregnancy, Foetal death, Premature delivery, Substance use
Clinical narrative: Case number PHHY2015US068689 is an initial spontaneous report received on 03 Jun 2015. The author discussed about the safety profile of pregnancy exposures to the quadrivalent human papillomavirus vaccine (qHPV) by acquiring and analyzing post marketing data on pregnancy outcomes from GARDASIL/SILGARD pregnancy registry. The registry enrollment criteria included an identifiable patient, exposure to HPV vaccine within one month prior to the date of onset of last menstrual period (LMP) or at any time during pregnancy, identification of health care provider and residency in a country where the registry was active. This report refers to an 18 year old pregnant female patient. Her medical history and concomitant medications were not reported. She was vaccinated with qHPV (other manufacturer, batch number: not reported) on an unknown date. It was reported that exposure to HPV vaccine occurred 1 week and 5 days from LMP. She concomitantly received influenza virus vaccine (manufacturer and batch number: not reported), ferrous sulphate (unknown manufacturer) and cannabis (unknown manufacturer) at 8 to 9 weeks of gestation. She had twin gestation delivered at 32 to 33 weeks of gestation. The death of first twin was diagnosed at 28 weeks and it was approximately 22 weeks by size at delivery (fetal death at 22 weeks of gestation). There were no abnormalities on autopsy. The second twin was born live with no abnormalities (see related case number: PHHY2015US069160). The author concluded the article stating that the rates of spontaneous abortions and major birth defects were not greater than the general population rates. Due to the nature of voluntary spontaneous reporting, no definitive conclusions could be made about the potential effects of exposure to qHPV vaccine during pregnancy and hence qHPV vaccine was not recommended for use in pregnant women.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash in B/L UE and upper chest. No SOB/mucous memb inv. Never had issues with IZ in the past.
Age: 1.06
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Rash papular
Clinical narrative: Papular rash over entire body-sparing palms, soles, perineum.