chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On 14-JAN-2014, the patient was vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported; lot # J006236, expiration date 25-FEB-2016). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medication and past drug history was unknown. On 30-JUN-2015 or 01-JUL-2015, the patient was vaccinated with (Oka/Merck) VARIVAX (dose and route unknown) lot# L002214 with expiry date 21-JAN-2017. The patient was administered the (Oka/Merck) VARIVAX after it had a temperature excursion. It was unknown if there was any relevant laboratory data. As of 02-JUL-2015 it was unknown if the patient will ever get the (Oka/Merck) VARIVAX again and the outcome of the (Oka/Merck) VARIVAX being given after an excursion was unknown. This is one of the several reports from the same reporter. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been receive from a pharmacist referring to a 50 year old female patient with high cholesterol, diabetes, depression, neuropathy. The patient had allergy with penicillin. On 10-JUL-2015 the patient was vaccinated with ZOSTAVAX (dose was unknown, lot # K020802 and expiry date: 31-JAN-2016, subcutaneous). Concomitant therapies included pravastatin, sertraline, metformin, gabapentin and NAPROXEN. On 12-JUL-2015 the patient developed pain, redness and swelling at the injection site. No lab diagnostics studies were performed. As a result, the patient started ADVIL for treatment. The patient went to see the pharmacist for medical attention. The patient had not recovered at the time of report. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as receive from a physician via field representative refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-JUL-2015, the patient was vaccinated with the expired dose of M-M-R II (lot number J006954 and expiration date 07-JUN-2015) (dose, route of administration not reported). No adverse effect was reported. Additional information has been requested.
Age: 0.23
Sex: F
Vaccine: DTAP
Symptoms: Crying, Dyspnoea, Vomiting
Clinical narrative: Crying for four hours, vomiting, extreme labored breathing for five hours.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, and localized redness and swelling around injection site the day after injection.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: CSF glucose increased, CSF lymphocyte count normal, CSF monocyte count decreased, CSF neutrophil count increased, CSF protein increased
Clinical narrative: Guillain Barre per clinical exam, LP, and EMG.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: CSF red blood cell count positive, CSF white blood cell count negative, Electromyogram abnormal, Guillain-Barre syndrome
Clinical narrative: Guillain Barre per clinical exam, LP, and EMG.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On an unknown date the patient was vaccinated with PEDVAXHIB (strength, dose, route and lot number unspecified) which underwent a supported temperature excursion (Incorrect product storage). No adverse effects were reported. This is one of the 23 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On an unknown date the patient was vaccinated with ROTATEQ (strength, dose and lot number unspecified) orally, which underwent a supported temperature excursion (Incorrect product storage). No adverse effects were reported. This is one of the 23 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 health worker referring to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored GARDASIL (dose, strength, route and lot# were not reported). No adverse experiences were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. Between 14-JUN-2015 and 14-JUL-2015, patients were vaccinated with doses of ZOSTAVAX that was improperly stored, lot # L011529, exp. date: 03-JUL-2016, 0.65 ml, subcutaneously (dose # and application site were not reported). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Publicis employee and a pharmacy technician referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX lot# reported as L001477 with expiry date 10-JUL-2016(dose, frequency and route were not reported), which was improperly stored. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 10-JUL-2015, the patient was inadvertently administered with one dose of expired M-M-R II, (dose was not provided), lot # 1684AA, batch # J006139, expiration date 17-APR-2015. No adverse effects were reported. Additional information has been requested.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis developed over the area where varicella and PCV 13 were given.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis developed over vaccine injection site on right leg after receiving varicella and PCV 13.
Age: 72.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Cold sweat, Injection site pain, Injection site reaction, Injection site swelling, Oedema peripheral
Clinical narrative: Patient reports onset of edema in both arms. In right arm pt experienced swelling around shoulder down to wrist. Injection site was sore. No redness, are was "clammy". In left arm pt experienced swelling of shoulder down to elbow, injection site soreness. No redness or warmth.
Age: 72.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Peripheral swelling
Clinical narrative: Patient reports onset of edema in both arms. In right arm pt experienced swelling around shoulder down to wrist. Injection site was sore. No redness, are was "clammy". In left arm pt experienced swelling of shoulder down to elbow, injection site soreness. No redness or warmth.
Age: 19.0
Sex: M
Vaccine: HEPA, HPV4, TD
Symptoms: Heart rate increased, Respiratory rate increased, Tremor
Clinical narrative: Per report, patient woke up from sleep with tremors. Was unable to suppress. Did not lose or alter consciousness. Did not lose control of bowel or bladder. Increased heart rate and respiratory rate. Last about an hour.
Sex: U
Vaccine: MMR
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 unspecified age and gender. Medical history and concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with improperly stored M-M-R II injection (lot number, dose, frequency and route of administration was not reported). No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. No further information was provided. 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 certified medical assistant refers to a patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On 24-JAN-2015, the patient was vaccinated with an improperly stored doses of GARDASIL (dose and route were not reported; lot # J006236, expiration date 25-FEB-2016). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of pediatric patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown dates, unspecified number of pediatric patients were vaccinated with a booster dose of VAQTA (lot number, Expiry date, dose and route were not reported), earlier than 6 months after the previous dose. No adverse experiences were reported. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. The reporter stated that since 16-JUN-2015, the patients were vaccinated with doses of ROTATEQ oral (Lot# K013861, expiration date 18-MAY-2016; Lot # K014826, expiration date 28-MAY2016) (doses and route were not specified), which were exposed to temperatures outside of the recommended range on 16-JUN-2015. No concomitant medications were reported. No adverse experience has been observed or reported. This is one of several reprots from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from the licensed practical nurse concerning 6 patients of unknown age and gender. The patients' concurrent conditions and concomitant medications were not reported. On unknown dates, patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot# K002919, expiry date 26-FEB-2016; dose and route of administration were not reported). Additional information is not expected as all the scheduled correspondence has been obtained. This is one of several reports from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unkonwn age and gender who on 15-MAY-2015 was vaccinated with a dose of oral ROTATEQ (lot # K016313) (dose and route not reported) that was 87 hours temperature excursion. This lot was received on 08-APR-2015. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse concerning a patient unknown gender and age. The patient's pertinent medical history and drug reactions or allergies were not reported. On 08-JUL-2015, the patient was inadvertently administered a dose of VARIVAX (Merck) (dose and lot# not provided) subcutaneous, instead of the intended dose of ZOSTAVAX. The ZOSTAVAX was not administered. No adverse effect was reported. No product confusion was reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Lip swelling, Pyrexia, Urticaria
Clinical narrative: Lips swelling, hives, fever.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site rash, Pruritus
Clinical narrative: Pt. developed rash on both upper arms (deltoid area) and slight erythematous on both ears. (+) mild pruritus.
Age: 68.0
Sex: F
Vaccine: HEP, PNC13
Symptoms: Erythema
Clinical narrative: Area of raised erythema approximately 2 inches wide x 3" long (R) upper arm-Hep B #1 given same arm above site (Hx breast CA (L) side).
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Tenderness, Vomiting
Clinical narrative: This spontaneous report was received from a health professional and refers to a 40 year old female patient. No medical history or concurrent conditions were reported. On 01-JUL-2015 at 03:39 PM, the patient was vaccinated with her first dose of VAQTA, 1 DF in the right deltoid (right arm). No concomitant medication reported. On 01-JUL-2015 at 6 PM, 2 hrs 21 min after onset of therapy the patient developed swelling, pain in her right shoulder with tenderness in the right axilla, the patient also had a fever with a body temperature between 102.8 - 101 (units unknown) and vomiting. On an unknown date, the patient undergone an evaluation which showed increase in WBC. The outcome of the events were unknown. The reporter did not assess the causality of the events with VAQTA. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: White blood cell count increased
Clinical narrative: This spontaneous report was received from a health professional and refers to a 40 year old female patient. No medical history or concurrent conditions were reported. On 01-JUL-2015 at 03:39 PM, the patient was vaccinated with her first dose of VAQTA, 1 DF in the right deltoid (right arm). No concomitant medication reported. On 01-JUL-2015 at 6 PM, 2 hrs 21 min after onset of therapy the patient developed swelling, pain in her right shoulder with tenderness in the right axilla, the patient also had a fever with a body temperature between 102.8 - 101 (units unknown) and vomiting. On an unknown date, the patient undergone an evaluation which showed increase in WBC. The outcome of the events were unknown. The reporter did not assess the causality of the events with VAQTA. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. The reporter stated that since 16-JUN-2015, the patients were vaccinated with doses of RECOMBIVAX HB (Lot # K020216, expiration date 17-SEP-2016; Lot # K016005, expiration date 27-AUG-2016) (doses and route were not specified), which were exposed to temperatures outside of the recommended range on 16-JUN-2015. No concomitant medications were reported. No adverse experience has been observed or reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.11
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Conjunctivitis, Hypophagia, Pyrexia, Rash generalised
Clinical narrative: Fever to 101.2 degrees (F)- decreased oral intake. Mild conjunctivitis. Discrete rash without vesiculation or confluence with spread from head down body.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Injury, Road traffic accident, Syncope
Clinical narrative: This spontaneous report as received from a Registered Nurse, via a company representative, refers to a currently 17 years old male patient. The patient's medical history and concurrent conditions were not reported. Approximately in 2014, reported as "around one year ago", the patient was vaccinated with his second dose of GARDASIL (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. According to the reporting nurse, after vaccine administration the patient experienced a syncope while driving his vehicle and struck another vehicle (road traffic accident). The patient sustained minimal injury. Whether the patient was observed for 15 minutes after vaccination, was not known. The reporting nurse stated that the patient sought unspecified medical attention. The outcome of road traffic accident, syncope and injury was reported as recovered on an unknown date. The reporter did not provide a causality assessment for the events. 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 patiens of unknown demographics. On an unknown date, an unspecified number of patients received improperly stored oral, ROTATEQ (dose details, lot number unspecified) (Incorrect storage of drug). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This case is also related to 1507USA007760, 1507USA007761 and 1507USA007759 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to patients of unknown demographics. On an unknown date, an unspecified number of patients received improperly stored (Oka/Merck) VARIVAX (dose details, lot number unspecified). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This case is also related to 1507USA007760, 1507USA007761 and 1507USA001935 (same reporter link). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Large local reaction, erythema and induration at site, BENADRYL and prednisone.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old female patient with no pertinent medical history and no known drug reactions/allergies. It was reported that on 11-MAY-2015 the patient was vaccinated with a second dose of PNEUMOVAX23, lot # K005402 and expiration date on 07-NOV-2015. The first dose was administered "many years ago" according to reporter. Concomitant medications included levofloxacin, albuterol sulfate (manufacturer unknown). promethazine, codeine and pravastatin. The reporter stated that patient began to experience on 11-MAY-2015 soreness in the inject arm shortly following the administration. A the time of the report, the patient was still experiencing soreness in the injection arm. The patient did not receive any treatment for the event. No laboratory test was performed. The patient sought medical attention by calling the physician and the pharmacy. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old male patient with no drug reactions or allergies. The patient had no pertinent medical history and took no concomitant medication. On 19-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX, 19400 PFU, 0.65 ml, subcutaneous in the left arm (lot # K018171, expiration date 23-OCT-2015). On 29-JUN-2015, the patient experienced painful rash, which started on the sole of one of his feet and had spread to the calf of the same unspecified lower extremity (the patient was diagnosed as having shingles). The patient was prescribed to take aciclovir 4 times a day for 7 days and gabapentin 300 mg three times a day as a treatment for the shingles. The patient started treatment on 09-JUL-2015. At the time of reporting the patient did not recover from the event. The patient sought medical attention. At the time of reporting the patient did not recover from the event. The patient sought medical attention. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysuria, Micturition urgency, Pollakiuria
Clinical narrative: This spontaneous reprot as received from a pharmacist refers to a 65 year old male patient. The patient's concurrent condition included benign prostatic hyperplasia. The patient had no past drug reactions or allergies. On 09-JUL-2015, the patient was subcutaneously vaccinated with dose of ZOSTAVAX lot # reported as L012475, expiration date 10-JUL-2016, (dose was not reported). Concomitant medications included FLOMAX. Approximately on 13-JUL-2015 (reported as possibly on 13-JUL-2015 or 14-JUL-2015), the patient began to experience frequency, urgency and burning upon urination. The patient was no given any treatment for the events. There were none lab diagnostic tests performed. The patients sought medical attention via calling the pharmacist. The outcome of the events and the vaccination with the ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an adult patient of unknown age and gender. On 29-JUN-2015, an adult patient was vaccinated in error with a dose of PEDVAXHIB (dose and lot# were not reported) intramuscular. No adverse effects reported. No Product quality Complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a female patient of unknown age. The patient's concurrent conditions, concomitant medications and medical history were not reported. On an unspecified date in 2014 (reported as about a year ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot#/batch#, expiration date were not reported), at an unspecified retail pharmacy. On an unknown date, the patient has been experiencing a red, itchy bumpy rash that 'comes and goes' since she received ZOSTAVAX. The rash would erupt and then resolve. The reporter could not provide any additional description of that rash. The outcome of event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not assessed. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Bronchitis
Clinical narrative: This spontaneous report was received from a female patient of unknown age (a nurse), reporting on herself. The patient's concurrent conditions and medical history included asthma and allergies/reactions to penicillin (unspecified), CHLOROMYCETIN, clindamycin, NEOSPORIN, DEMEROL. On unknown date, the patient was vaccinated with the first dose of PNEUMOVAX 23 25/0.5 (unit not provided) (dose, lot#, expiration date, route and site of vaccination were not reported). In 2002, the patient was vaccinated with the second dose of PNEUMOVAX 23 25/0.5 (unit not provided) (dose, lot#, expiration date, route and site of vaccination were not reported). In 2008, the patient was vaccinated with the third dose of PNEUMOVAX 23 25/0.5 (unit not provided) (dose, lot#, expiration date, route and site of vaccination were not reported). Concomitant therapies included SYMBICORT, albuterol and unspecified allergies shots. On unknown date, the patient experienced a bronchial infection. At the time of this report, the patient was recovering from the infection. There was no information about product quality complains (PQC) reported. The patient did not seek medical attention. The reporter stated that the bronchial infection was not related to PNEUMOVAX 23 and was viral in nature. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 25-AUG-2010, the patient was vaccinated with the first dose, on 14-JAN-2011 with the second dose and on 09-JUL-2014 with the third dose of GARDASIL (dose, route of administration and lot # were not reported). No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health professional (nurse) refers to an 18 year old patient. Patient's medical history, concurrent conditions and drug reactions/ allergies were not reported. On an unknown date the patient was inadvertently vaccinated with an adult formulation of RECOMBIVAX HB, 10 Microgram (inappropriate schedule of drug administration). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the registered nurse (R.N.) refers to an unspecified patient of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot number, dose, frequency and route not reported). No concomitant medications were reported. No adverse events were experienced. The outcome of incorrect product storage was unknown. No product quality complaint (PQC) was filed. No further information was provided. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Injection site reaction, Injection site warmth
Clinical narrative: (R)and (L) arm large round circles at injection site warm to touch.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional (nurse) refers to an unspecified number of patients of unknown demographics. Medical history, concurrent conditions and drug reactions/ allergies of these patients were not reported. On an unknown date these patients were vaccinated with improperly stored VARIVAX (Merck). Concomitant therapy was not reported. No adverse effects were reported. This is one of the two reports received from the same source (MARRS # 1507USA005406). 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 health professional (nurse) refers to an unspecified number of patients of unknown demographics. Medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. On an unknown date these patients were vaccinated with improperly stored PROQUAD (Merck) (lot # K018143, expiry date: 10-APR-2016). Concomitant therapy was not reported. No adverse effects were reported. This is one of the two reports received from the same source (MARRS # 1507USA007754). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender who on unknown dates were vaccinated with improperly stored doses of VAQTA (dose, route, lot # and expiration date were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown gender, between 40-49 years of age who on an unknown date was vaccinated with ZOSTAVAX. No adverse effects reported. The outcome of inappropriate schedule of drug administration was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to patients of unknown demographics. On an unknown date, an unspecified number of patients received improperly stored PROQUAD (Merck) lot # L005295 (expiry date: 17-AUG-2016) (dose details, lot number unspecified). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This case is also related to 1507USA001935, 1507USA007761 and 1507USA007759 (same reporter link). Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Discomfort, Injection site rash, Swelling face
Clinical narrative: Dad phoned 7-16-15 said night after vaccines pt had face swelling and face felt heavy. No trouble breathing. Rash on back of shoulder not where vaccines were given-went to ER 7-15-15. Face not as swollen and rash some better. No trouble breathing.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 03-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender who on unknown dates were vaccinated with improperly stored doses of GARDASIL (dose, route, lot # and expiration date were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to patients of unknown demographics. On an unknown date, an unspecified number of patients received improperly stored GARDASIL (dose details, lot number unspecified). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This case is also related to 1507USA007760, 1507USA001935 and 1507USA007759 (same reporter link). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm is with swelling, warmth and redness measuring approximately 7cm X9cm.  Client did relate that it hurts.  Was noticed as still being red when she got out of the swimming pool and is in the same area as her shot.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Cyanosis, Death, Peripheral coldness, Pulse absent, Respiratory arrest
Clinical narrative: Cold, Blue, not breathing, Lifeless, no pulse.
Age: 0.34
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Lacrimation increased, Pyrexia, Retching, Swelling face
Clinical narrative: Watery eyes. Red, puffy skin around the eyes and on the cheeks. Redness on the chest. Fever of 101.5, although possibly higher (taken with an ear thermometer, which tends to read about one degree (F) cooler than actual body temperature). Infant Tylenol (suspension) was administered, but she vomited due to gagging. Cold, wet rags were then placed on her torso, and that brought the fever down.
Age: 0.34
Sex: F
Vaccine: DTAP, IPV
Symptoms: Vomiting
Clinical narrative: Watery eyes. Red, puffy skin around the eyes and on the cheeks. Redness on the chest. Fever of 101.5, although possibly higher (taken with an ear thermometer, which tends to read about one degree (F) cooler than actual body temperature). Infant Tylenol (suspension) was administered, but she vomited due to gagging. Cold, wet rags were then placed on her torso, and that brought the fever down.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Cellulitis, Pruritus
Clinical narrative: Patient stated that her arm was itching as soon as she got home after receiving vaccine. Patient went to urgent care on 7/15/15 and was diagnosed with cellulitis. She described having blisters covering arm she received vaccine in (right arm).
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient stated that her arm was itching as soon as she got home after receiving vaccine. Patient went to urgent care on 7/15/15 and was diagnosed with cellulitis. She described having blisters covering arm she received vaccine in (right arm).
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site vesicles, Injection site warmth, Nausea, Pain
Clinical narrative: Patient stated that her arm was itching as soon as she got home after receiving vaccine. Patient went to urgent care on 7/15/15 and was diagnosed with cellulitis. She described having blisters covering arm she received vaccine in (right arm).
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site pain
Clinical narrative: Shoulder site tenderness then soreness increased. Headache started about 9:00 PM and continued into today the 16th and intensified early this AM. 2 Aleve taken about 8:00 AM has done nothing to relieve the shoulder soreness nor the headache.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: 3 days later, cellulitis developed on left arm, treated with IV antibiotics and followed by oral antibiotics.
Age: 38.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Lip swelling
Clinical narrative: CLIENT WOKE UP WITH LIPS SWOLLEN 2-3 TIMES THEIR NORM. CLIENT WENT TO ER AND RECV'D STEROID AND ANOTHER MED. CLIENT COULD NOT GIVE NAMES OF MEDS. LIPS RETURNED TO NORMAL SIZE.
Age: 33.0
Sex: M
Vaccine: ANTH, TDAP, TYP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: He reports that in July of 2011 he received an Anthrax dose (IM dose number 5) in his left shoulder with only local redness, pain and swelling at the site. Denies nasal, ocular, cutaneous, lip/tongue/oral/throat, pulmonary, GI and CV symptoms. Denies fever/chills, muscle/joint pain/swelling. Over the next week after vaccination he noted a "lump" at the vaccination site that has persisted without change since that time. Denies pain, warmth, tenderness and drainage from site. Denies issues with prior doses of Anthrax (he has not received subsequent doses) and has tolerated all other prior and subsequent vaccine doses without adverse reactions. US of affected area read as consistent with lipoma.
Age: 33.0
Sex: M
Vaccine: ANTH, TDAP, TYP
Symptoms: Lipoma, Ultrasound scan abnormal
Clinical narrative: He reports that in July of 2011 he received an Anthrax dose (IM dose number 5) in his left shoulder with only local redness, pain and swelling at the site. Denies nasal, ocular, cutaneous, lip/tongue/oral/throat, pulmonary, GI and CV symptoms. Denies fever/chills, muscle/joint pain/swelling. Over the next week after vaccination he noted a "lump" at the vaccination site that has persisted without change since that time. Denies pain, warmth, tenderness and drainage from site. Denies issues with prior doses of Anthrax (he has not received subsequent doses) and has tolerated all other prior and subsequent vaccine doses without adverse reactions. US of affected area read as consistent with lipoma.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Fatigue, Pyrexia, Vomiting
Clinical narrative: Tired, Fever (100.5), Vomiting.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Patient reports pulling sensation right side of neck; 11cm(L)x8cm(W) red-raised -hot- painful & tender to the touch right Deltoid with painful ROM. MD Evaluation: +Rash; +Warm & erythemous local skin reaction Right Deltoid - no induration. Treatment: Rx Motrin 800 mg One tab orally every 8 hours as needed for Pain.  Return in 1 week if worse or fail to improve.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Musculoskeletal discomfort, Pain, Skin reaction
Clinical narrative: Patient reports pulling sensation right side of neck; 11cm(L)x8cm(W) red-raised -hot- painful & tender to the touch right Deltoid with painful ROM. MD Evaluation: +Rash; +Warm & erythemous local skin reaction Right Deltoid - no induration. Treatment: Rx Motrin 800 mg One tab orally every 8 hours as needed for Pain.  Return in 1 week if worse or fail to improve.
Age: 18.0
Sex: M
Vaccine: HEPAB, HPV9
Symptoms: Abdominal discomfort, Abdominal pain, Activities of daily living impaired, Arthralgia, Asthenia
Clinical narrative: Joint Pains, uncontrollable shaking, Weight loss 10lbs., upset stomach, Muscle weakness pain, fatigue, abdominal/chest pain, pressure in head, marks on skin, fainting, seizure like episode.
Age: 18.0
Sex: M
Vaccine: HEPAB, HPV9
Symptoms: Autoimmune disorder, Blood test normal, Chest pain, Fatigue, Head discomfort
Clinical narrative: Joint Pains, uncontrollable shaking, Weight loss 10lbs., upset stomach, Muscle weakness pain, fatigue, abdominal/chest pain, pressure in head, marks on skin, fainting, seizure like episode.
Age: 18.0
Sex: M
Vaccine: HEPAB, HPV9
Symptoms: Inflammation, Muscular weakness, Myalgia, Pain, Seizure like phenomena
Clinical narrative: Joint Pains, uncontrollable shaking, Weight loss 10lbs., upset stomach, Muscle weakness pain, fatigue, abdominal/chest pain, pressure in head, marks on skin, fainting, seizure like episode.
Age: 18.0
Sex: M
Vaccine: HEPAB, HPV9
Symptoms: Skin disorder, Syncope, Tremor, Weight decreased
Clinical narrative: Joint Pains, uncontrollable shaking, Weight loss 10lbs., upset stomach, Muscle weakness pain, fatigue, abdominal/chest pain, pressure in head, marks on skin, fainting, seizure like episode.
Age: 20.0
Sex: F
Vaccine: MNQ, TYP, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: REDNESS, SWELLING, WARM TO TOUCH.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area near injection became red and hot and an area about the size of 5X7 inches.  At time reported to me the rxn was improving and was significantly better.  No treatments was sought.  As of 07/16/2015 pt is recovering.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Skin warm, Tenderness
Clinical narrative: Induration, reaction site measured 4.5 x 3 cm, redness, warmth, itchy, tenderness. Adverse Event lasted approx. one week. Advised to take Benadryl for itching & Tylenol for tenderness.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood culture negative, CSF culture negative, Crying, Culture urine negative, Eye movement disorder
Clinical narrative: Patient was given Pentacel, Prevnar, Hep B, and Rotateq in the office and around 3 to 4 hours after patient developed a tactile temp and was given Tylenol by her mother.  Subsequently, patient began crying inconsolably and immediately became pale and limp with eyes rolling upward.  Her mother attempted to stick finger down patient's throat to elicit emesis thinking that the Tylenol may have caused the episode.  Patient regained tone and began crying without regurgitation.  The episode lasted less than one minute per mom although exact timing was unclear.  There were no tonic-clonic movements of extremities.  Patient was admitted to Hospital and rule out sepsis work up was done, placed on ceftriaxone until cultures were negative.  Sent home with possible diagnosis of HHE after 3 days.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hypotonia, Pallor, Skin warm
Clinical narrative: Patient was given Pentacel, Prevnar, Hep B, and Rotateq in the office and around 3 to 4 hours after patient developed a tactile temp and was given Tylenol by her mother.  Subsequently, patient began crying inconsolably and immediately became pale and limp with eyes rolling upward.  Her mother attempted to stick finger down patient's throat to elicit emesis thinking that the Tylenol may have caused the episode.  Patient regained tone and began crying without regurgitation.  The episode lasted less than one minute per mom although exact timing was unclear.  There were no tonic-clonic movements of extremities.  Patient was admitted to Hospital and rule out sepsis work up was done, placed on ceftriaxone until cultures were negative.  Sent home with possible diagnosis of HHE after 3 days.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: C-reactive protein increased, Groin pain, Injection site reaction, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Very sore left upper arm at the vaccine site which never improved, then worsened.  She then developed pain and stiffness in the whole shoulder, the other shoulder and both groin areas.  She developed increasing pain and stiffness over the next 2 1/2 weeks and was diagnosed with polymyalgia rheumatica on 07/13/15.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Polymyalgia rheumatica, Red blood cell sedimentation rate increased, Vaccination site pain
Clinical narrative: Very sore left upper arm at the vaccine site which never improved, then worsened.  She then developed pain and stiffness in the whole shoulder, the other shoulder and both groin areas.  She developed increasing pain and stiffness over the next 2 1/2 weeks and was diagnosed with polymyalgia rheumatica on 07/13/15.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Abasia, C-reactive protein increased, Insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Very sore left upper arm at the vaccine site which never improved, then worsened.  She then developed pain and stiffness in the whole shoulder, the other shoulder and both groin areas.  She developed increasing pain and stiffness over the next 2 1/2 weeks and was diagnosed with polymyalgia rheumatica on 07/13/15.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: Very sore left upper arm at the vaccine site which never improved, then worsened.  She then developed pain and stiffness in the whole shoulder, the other shoulder and both groin areas.  She developed increasing pain and stiffness over the next 2 1/2 weeks and was diagnosed with polymyalgia rheumatica on 07/13/15.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Blood test, Malaise, Myalgia, Pain in extremity
Clinical narrative: Very sore left upper arm at the vaccine site which never improved, then worsened.  She then developed pain and stiffness in the whole shoulder, the other shoulder and both groin areas.  She developed increasing pain and stiffness over the next 2 1/2 weeks and was diagnosed with polymyalgia rheumatica on 07/13/15.
Age: 0.33
Sex: F
Vaccine: DTAPH, IPV, PPV, RVX
Symptoms: Anticonvulsant drug level above therapeutic, Electrocardiogram normal, Seizure
Clinical narrative: Patient had a seizure that lasted a little over 3 minutes. Exactly one week following that seizure, she had another one on 06/06/2015 she had another one also at 9:00 AM.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to anonymous patients. On an unknown date, anonymous patients were vaccinated with VARIVAX (Merck) that was exposed to a post temperature excursion (lot# K016128; Expiration date 23-SEP-2016) and (lot# K007979; Expiration date 03-JUN-2016) dose and route of vaccination were unknown. No adverse effects noted by any patients. 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 unspecified number of patients of unknown age and gender who on unknown dates were vaccinated with improperly stored doses of ROTATEQ (dose, route, lot # and expiration date were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information was received from a Medical assistant on 02-JUL-2015 concerning a patient of unknown age and gender who on 21-APR-2015, was vaccinated with a dose of ROTATEQ lot # K011663 (expiration date, dose, route and site of administration were not reported) that was exposed to temperatures outside of the recommended range. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 06-JUL-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) first dose, lot L009209, expiration date: 17-SEP-2016, 0.5 ml, subcutaneous. No concomitant therapies were reported. No adverse effects were reported. This is one of multiple reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. The patient experienced no adverse event. Additional information is not expected.