chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, route, lot # and expiration date were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: This spontaneous report has been received from a 56 year old female consumer. None concurrent conditions, pertinent medical history or drug reactions/allergies were reported. On 23-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX lot # L012039, exp date on 07-JUL-2016, 0.65 ml, subcutaneous in her right arm. The patient concomitantly received the influenza virus vaccine (product name unspecified) in the opposite arm (left arm) on an unspecified date in 2015. On 24-NOV-2015, the patient noticed that she had developed redness and there was a "hard lump about the size of an egg" around the ZOSTAVAX injection site and it also felt warm to the touch. The patient did not seek medical attention. Therefore, no laboratories were performed and there was no treatment given for the adverse events. There was no hospitalization or prolonged. At the reporting time, the patient present status was reported as not recovered. The causal assessment of injection site lump, injection site warmth and injection site redness to ZOSTAVAX was not reported. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 13 year old patient of unknown gender. There was no information about the patient's concomitant medications and pertinent medical history reported. On 02-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot# K023432, expiration date 18-JUN-2016) (strength, dose, route and site of administration were not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 16 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 11-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K007828 expiration date 02-MAR-2017. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and 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 26-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L011846, expiration date 16-JUN-2017 (strength, dose and route of administration were not provided). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 10 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-SEP-2015, the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (dose was not provided) lot # K016261, expiration date: 23-JUN-2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and 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 19-SEP-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # K010221, expiration date 12-MAY-2016 (strength and dose were not provided). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 3 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 27-JUL-2015 and 28-SEP-2015, the patient was vaccinated with two separate doses of improperly stored ROTATEQ (doses were not provided) lot # K023534, expiration date: 22-MAY-2016 and lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 11 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 12-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K007828 expiration date 02-MAR-2017. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 10-year-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # reported as L011846, expiration date was reported as 16-JUN-2015) (dose, route and site of administration were not provided). Concomitant medications were not reported. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 13-year-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 05-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # reported as L011846, expiration date reported as 16-JUN-2017) (dose, route and site of administration were not provided. Concomitant medications were not reported. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L031602 and expiration date 18-FEB-2017, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 16-year-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 12-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # reported as L011846, expiration date was reported as 16-JUN-2017) (dose, route and site of administration were not provided). Concomitant medications were not reported. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 9 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-AUG-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was not provided) lot # K023534, expiration date: 22-MAY-2016, orally. No adverse effects were reported. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 3 year old patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 25-NOV-2015, the patient was inadvertently administered a dose of GARDASIL 9 (dose and route were not reported, lot # L013429 with expiration date: 21-JUL-2017). No adverse effect was reported. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15-year-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 23-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # reported as L011846, expiration date was reported as 16-JUN-2017) (dose, route and site of administration were not provided). Concomitant medications were not reported. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 25-year-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 04-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L010596, expiration date reported as 06-APR-2017) (dose, route and site of administration were not provided). Concomitant medications were not reported. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot # L004754; Expiration date: 10-NOV-2016) (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 08-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K007828 expiration date 02-MAR-2017. On 12-AUG-2015, the patient was again vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K011562 expiration date 08-APR-2017. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 11-year-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 05-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # reported as L011846, expiration date was reported as 16-JUN-2017) (dose, route and site of administration were not provided). Concomitant medications were not reported. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date in 2008 the patient was vaccinated with dose 1 of GARDASIL (# lot/batch, dose, route unknown) and never received the rest of the series. Product quality complaint was not filed. Additional information is not expected as no contact details for further follow up were provided.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12-year-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 20-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K011562, expiration date reported as 08-APR-2017) (dose, route and site of administration were not provided). Concomitant medications were not reported. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12-year-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 10-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # reported as L011846, expiration date was reported as 16-JUN-2015) (dose, route and site of administration were not provided). Concomitant medications were not reported. No adverse effects was 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 was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). The patient's pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (Lot # K018965; Expiration date: 15-OCT-2016 and Lot# L007577; Expiration date: 05-MAR-2017) (dose and route were not provided). 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: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 5 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 10-AUG-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016; dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 year old patient. On 20-NOV-2015, the patient was inadvertently vaccinated with a dose of adult formulation of VAQTA (lot# L017757 and expiry date: 08-APR-2018). No adverse effects were reported. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 16 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 02-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K007828 expiration date 02-MAR-2017. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Chills, Fatigue, Inappropriate schedule of drug administration, Laboratory test normal
Clinical narrative: Information has been received from a pharmacist referring to a 54 year old female patient with diabetes. The patient had no drug reactions/allergies. On 26-NOV-2013, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot# J010654, expiration 17-OCT-2014, dose was not reported) intramuscularly for prevention of pneumococcal disease. Then on 17-SEP-2015 the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot # L003227, expiration 13-OCT-2016, dose was not reported) intramuscularly for prevention of pneumococcal disease. "Within an hour" after receiving the second dose of PNEUMOVAX 23 on that day, the patient developed "persistent" chills, myalgia, and fatigue, for which she had visited her physician several times. Patient also experienced "chest heaviness," (unspecified date) for which she visited her physician twice on 09-OCT-2015 and 22-OCT-2015; each time, unspecified "cardiac studies" were normal. Treatment including TYLENOL of extra-strength and ALEVE was given for these events. Pharmacist reported the patient's chills, myalgia, and fatigue had not resolved, but it was unspecified whether the "chest heaviness" had resolved. Pharmacist provided the concomitant medications the patient was currently prescribed gemfibrozil, glyburide, metformin, omeprazole (manufacturer unknown), paroxetine, simvastatin (manufacturer unknown), but also stated that she could not be certain whether the patient was taking them as prescribed. Causality was not reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Information has been received from a pharmacist referring to a 54 year old female patient with diabetes. The patient had no drug reactions/allergies. On 26-NOV-2013, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot# J010654, expiration 17-OCT-2014, dose was not reported) intramuscularly for prevention of pneumococcal disease. Then on 17-SEP-2015 the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot # L003227, expiration 13-OCT-2016, dose was not reported) intramuscularly for prevention of pneumococcal disease. "Within an hour" after receiving the second dose of PNEUMOVAX 23 on that day, the patient developed "persistent" chills, myalgia, and fatigue, for which she had visited her physician several times. Patient also experienced "chest heaviness," (unspecified date) for which she visited her physician twice on 09-OCT-2015 and 22-OCT-2015; each time, unspecified "cardiac studies" were normal. Treatment including TYLENOL of extra-strength and ALEVE was given for these events. Pharmacist reported the patient's chills, myalgia, and fatigue had not resolved, but it was unspecified whether the "chest heaviness" had resolved. Pharmacist provided the concomitant medications the patient was currently prescribed gemfibrozil, glyburide, metformin, omeprazole (manufacturer unknown), paroxetine, simvastatin (manufacturer unknown), but also stated that she could not be certain whether the patient was taking them as prescribed. Causality was not reported. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 9 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 15-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiration date 17-JAN-2016, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 02-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K007828 expiration date 02-MAR-2017. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. No pertinent or historical conditions were reported. On 21-NOV-2015, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously to get vaccinated (lot # L015414, expiration date 01-AUG-2016). There was no concomitant medication reported. On an unknown date of November 2015, the patient reported that there was swelling and her skin felt hard and lumpy around the injection site. The patient also reported that the hard lump was spreading around the injection site and noted that the lump was getting bigger. The pharmacist reported that the lump was not a rash, but an injection site reaction. The patient sought medical attention via calling the pharmacist. No treatment or lab diagnostics studies were performed to the patient, at the time of reporting, the outcome of events was reported as not recovered. Causality between event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a 66 year old female patient enrolled in a Market Research program, referring to herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (formulation, dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced bad reaction. The outcome of bad reaction was unknown. The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported. Additional information is not expected as there was no consent for follow up.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 14 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 01-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K007828 expiration date 02-MAR-2017. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified patient of unknown age and gender. There was no concurrent condition or medical history reported. No drug reactions/allergies was provided. On 16-NOV-2015 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # K005402, expiration date 07-NOV-2015) (dosage, strength and route were not reported). There was no concomitant medication reported. The vaccine was properly stored. No adverse effects was reported. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Papule, Pruritus
Clinical narrative: This spontaneous report was received from a 45 years old pharmacist who was also a patient and refers to himself. No medical history and concurrent conditions of the patient were reported. On 10-NOV-2015 (reported as Tuesday), the pharmacist was reconstituted a dose of ZOSTAVAX vial of strength 19400 PFU (lot number: L024997 and expiry date: October 2016) for an unspecified patient without wearing gloves. No concomitant medications were reported. The patient began to experience itching on the chest later in the afternoon of the same day. The patient does not know if any droplets of the ZOSTAVAX solution splashed on him on 10-NOV-2015. The patient also reported that on the next day (on 11-NOV-2015) he developed "purple papules" on his chest. The patient did not sought for the medical attention and did not consulted the healthcare provider and the patient was not recovered from itching and purple papules. The outcome of accidental exposure to product was not reported. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 52 year old female patient. The patient was allergic to sulfonamides, propoxyphene, nonsteroidal anti-inflammatory drugs (NSAIDs), zafirlukast, codeine and codeine derivatives. The patient had no pertinent medical history. On 20-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml once (lot# and expiration date unspecified) subcutaneously. Concomitant therapies included alprazolam, promethazine, PROAIR, SYMBICORT, hydrochlorothiazide (manufacturer unknown), CONCERTA, losartan potassium (manufacturer unknown), clonidine, montelukast sodium (manufacturer unknown) and metformin. On 20-NOV-2015, after receiving ZOSTAVAX, the patient developed injection site swelling, which grew to an area of "6 by 6 inches". The patient called to the pharmacist to seek unspecified medical attention. No treatment was given for the event. No other lab diagnostics studies were performed. At the reporting time, the swelling had begun to improve and had reduced to an area of "3 by 3 inches". Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 10-AUG-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016; dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
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 unknown gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL 9 (1 dose of lot # L007560 and expiry date: 15-JUN-2017). No adverse effects were reported. This is one of the several reports 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 unknown gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses GARDASIL (lot # K011562 and expiry date: 08-APR-2017). No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 12-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiration date 17-JAN-2016, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (Merck) (3 doses of lot # L026405 and expiry date: 15-JUL-2017 and 3 doses of lot# L018002 and expiry date: 19-MAY-2017). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 01-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K007828 expiration date 02-MAR-2017. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. 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 nurse refers to an unspecified number of patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # K019933 and expiry date: 20-APR-2016, lot # L007720 and expiry date: 08-JUL-2016). No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 07-AUG-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016; dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of M-M-R II (6 doses of lot # L001336 and expiry date: 13-JAN-2017). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an approximately 57 years old female patient. The patient's concurrent conditions included unspecified allergies. On 21-JUL-2013 the patient was vaccinated with ZOSTAVAX (strength, dose frequency and route were not reported). Concomitant medications included unspecified eye drops and unspecified antihistamines. The reporter stated that on an unspecified date in the beginning of October 2015 the patient was diagnosed with a case of shingles. Patient sought medical attention by visiting to the office. The outcome of herpes zoster was reported as not recovered. There was no product quality complaint. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 24 year old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unspecified date in July 2015 (reported a four months ago), the patient was vaccinated with a dose of GARDASIL 9 (dose, route, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug allergies were reported. The reporter stated that on 13-JUL-2015 the patient who started HPV series with GARDASIL 9 (strength, dose, frequency and route were not reported). Also reported that on an unknown date patient received second dose in the series GARDASIL (strength, dose, frequency and route were not reported) (interchange of vaccine products). No adverse effects were reported. The outcome of the event (interchange of vaccine products) was unknown. Causality assessment between the event and the suspect therapies GARDASIL 9 and GARDASIL was unknown. There was no product quality complaint. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 67 year old male patient reporting on himself. The patient did not have any pertinent medical history and drug reactions or allergies. The patient's concomitant therapies included several unspecified medications. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, lot # and expiration date were not reported, frequency: one shot (also reported as therapy was not discontinued), route reported as injection). On 18-JUN-2015, the patient experienced shingles. The patient was treated with valacyclovir hydrochloride generic medication. No laboratory tests were performed. The patient sought medical attention by visiting the doctor. The outcome of shingles was reported as not recovered/not resolved. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Arthralgia, Blood test normal, Muscle tightness, Musculoskeletal pain
Clinical narrative: This spontaneous report was received from a 60 year old male pharmacist who was reporting on himself. The patient's concurrent conditions included hypertension. The patient had no allergies. His medical history included shingles. He stated he was healthy, active and muscular. On 02-NOV-2015, the patient was vaccinated with ZOSTAVA 0.65 ml, subcutaneously in the left arm, lot/batch # reported as 15731P, expiration date May 2016. Concomitant therapies included lisinopril (manufacturer unknown) and hydrochlorothiazide, the patient was on his hypertension medications for over 20 years. On an unknown date in approximately November 2015, the patient experienced severe joint pain in both legs, shoulders and his hand. His leg joint pain was so bad his muscle felt like guitar strings pulled tight. He could not even put his legs inside his pants when dressing. At the time of the report, the patient's age were bit better, but still hurt. However, his shoulder muscles were most painful including his hand. The patient sought medical attention, he contacted his physician but at this time no treatment was given. On an unspecified dates, the patient had arterial blood pressure studies on his ankles and wrists performed and he passed with flying colors. He also had blood work drawn which was all within normal limits. The outcomes of the events were reported as not recovered. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a 60 year old male pharmacist who was reporting on himself. The patient's concurrent conditions included hypertension. The patient had no allergies. His medical history included shingles. He stated he was healthy, active and muscular. On 02-NOV-2015, the patient was vaccinated with ZOSTAVA 0.65 ml, subcutaneously in the left arm, lot/batch # reported as 15731P, expiration date May 2016. Concomitant therapies included lisinopril (manufacturer unknown) and hydrochlorothiazide, the patient was on his hypertension medications for over 20 years. On an unknown date in approximately November 2015, the patient experienced severe joint pain in both legs, shoulders and his hand. His leg joint pain was so bad his muscle felt like guitar strings pulled tight. He could not even put his legs inside his pants when dressing. At the time of the report, the patient's age were bit better, but still hurt. However, his shoulder muscles were most painful including his hand. The patient sought medical attention, he contacted his physician but at this time no treatment was given. On an unspecified dates, the patient had arterial blood pressure studies on his ankles and wrists performed and he passed with flying colors. He also had blood work drawn which was all within normal limits. The outcomes of the events were reported as not recovered. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) and refers to a male patient of current age 17 years. No medical history and concurrent conditions of the patient was reported. On 13-AUG-2015, the patient was vaccinated with first dose of GARDASIL injection of strength 120 Y (lot # K016966 and expiry date: 10-MAY-2017) subcutaneously in the right arm. No concomitant medications were reported. The R.N. reported that in 2015 (dates unspecified), the patient experienced unspecified hives following the vaccination. The patient was not treated for the adverse event and did not sought any medical attention. The patient recovered from the hives in 2015 (exact dates unspecified). No product quality complaint (PQC) was filed. No further information was provided. Additional information has been requested.
Age: 1.03
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 12 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 12-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiration date 17-JAN-2016, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.03
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 12 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 03-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiration date 17-JAN-2016, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.09
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 13 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 02-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiration date 17-JAN-2016, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 81.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an 81 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # K006681, expiration date: 21-OCT-2015 (dose and route were not reported). No adverse effects were reported. 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 medical assistance and refers to a patient of unknown demographics. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On approximately 23-NOV-2015 (reported as "on either 23-NOV-2015 or 24-NOV-2015"), the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) lot # reported as L019998, expiration date: 02-DEC-2016 (dose and route were not provided). No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 08-SEP-2014, the patient was vaccinated with the first dose of ZOSTAVAX (lot number, expiration date not reported) dose, route and anatomical location were not specified and on 17-NOV-2015 the patient received the second dose of ZOSTAVAX (lot number, expiration date not reported) dose, route and anatomical location were not specified. No concomitant medication was reported. No adverse effect was reported. No product quality complaint was involved. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 1.18
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 14 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 01-OCT-2015, the patient was vaccinated with improperly stored doses of M-M-R II (lot # K000738, expiration date 16-JAN-2016, exact dose and route of administration were not reported) and VARIVAX (Merck) (lot # K002046, expiration date 10-FEB-2016, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 12 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 21-SEP-2015, the patient was vaccinated with improperly stored doses of MMR II (lot # K000738, expiration date 16-JAN-2016, exact dose and route of administration were not reported) and (Oka/Merck) VARIVAX (lot # K002046, expiration date 10-FEB-2016, exact dose and route of administration were not reported. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blood disorder
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a female patient of unknown age. The patient's current conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (formulation, strength, dose, frequency, route and lot number were not reported). On an unknown date, the patient developed an unspecified "blood disorder" following administration of ZOSTAVAX. The patient sought medical attention and visited physician and pharmacy. The patient did not receive treatment for the event. Product quality complaint (PQC) was not involved. No further information was provided. The outcome of the event blood disorder was not resolved. The reporter did not provide causal relationship between the event and suspect therapy. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 5 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 10-SEP-2015, the patient was vaccinated with improperly stored doses of MMR II (lot # K000255, expiration date 08-JAN-2016, exact dose and route of administration were not reported) and (Oka/Merck) VARIVAX (lot # K002917, expiration date 26-FEB-2016, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional informational has been requested.