chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medications and medical history was not provided. Since 14-NOV-2014 (on unspecified dates of November 2014), the patients were vaccinated with doses of ROTATEQ (oral, lot#, dose and frequency were not provided), which were exposed to unknown temperatures since 14-NOV-2014 (due to the MinMax feature of the thermometer not being cleared with each temperature reading). Because the temperatures to which the vaccines had been exposed were not known, it was not known whether or not the vaccines were supported. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were unspecified by reporter. On 15-NOV-2014 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, lot# K009810, expiry date: 10-OCT-2015, anatomical location unknown) that underwent an unsupported temperature excursion. No adverse experience reported. The outcome of the events was unknown. 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 medical assistant, refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, unspecified patients were administered RECOMBIVAX HB (strength, dose, route, lot# were not reported) which were exposed to temperatures of 10 degrees Celsius for 7 hours and 45 minutes. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 14-NOV-2014 (dates unspecified), the patients were vaccinated with doses of MMR II (injection, lot#, dose, route and frequency were not provided), which were exposed to unknown temperatures since 14-NOV-2014 (due to the MinMax feature of the thermometer not being cleared with each temperature reading). Because the temperatures to which the vaccines had been exposed were not known, it was not known whether or not the vaccines were supported. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 14-NOV-2014 (on unspecified dates of November 2014), the patients were vaccinated with doses of GARDASIL (indication: lot#, dose, route and frequency were not provided), which were exposed to unknown temperatures since 14-NOV-2014 (due to the MinMax feature of the thermometer not being cleared with each temperature reading). Because the temperatures to which the vaccines had been exposed were not known, it was not known whether or not the vaccines were supported. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. On 19-NOV-2014 the patient was vaccinated with RECOMBIVAX HB 2.5 microgram/0.5ml (route and lot unspecified), expiry date: 31-MAY-2014. On 19-NOV-2014, the patient was vaccinated with an expired RECOMBIVAX HB. It was unspecified if it was the patient's first dose. No adverse effect was reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tremor
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old female patient. The patient was not pregnant. The patient's pertinent medical history was none. The patient had no known drug allergies. On 13-JAN-2014, the patient was vaccinated with second dose of GARDASIL (dose, frequency and route were not reported) (lot # J014295 and expiry date: 11-AUG-2016). Concomitant medications were none. Approximately in January 2014 (reproted as a week later on an unspecified date), the patient fainted in the bathroom before breakfast. The patient also experienced shakiness in her one hand on an unspecified date. The patient did not sought medical attention and no treatment was given for the events. The outcome of fainted in the bathroom before breakfast and shakiness in her one hand was reported as recovered on an unspecified date. The causality of the events was not reported. No product quality complaint (PQC) was reported for GARDASIL. 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 nurse refers to a patient of unknown age and gender. Medical history was not reported. On an unknown date in November 2014 (also reported as within the last week) on dose of improperly stored PROQUAD (Merck) injection (strength, dosage, route, lot # and expiration date were not reported). No adverse effects were 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, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. On an unknown date in November 2014 (also reported as within the last week) on dose of improperly stored (Merck) VARIVAX injection (strength, dosage, route, lot number and expiration date were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to his 60 year old female aunt. The reporter stated that he was not familiar with his aunt's medical history but appeared to be diabetic, no known drug allergies. His aunt reported to him that on 08-NOV-2014 she was vaccinated with a dose of ZOSTAVAX (Lot no. K009198, exp. 27-SEP-2015), subcutaneously in the upper arm. On 09-NOV-2014 the patient injection site felt sore and also experienced malaise, body ache and headache. On 10-NOV-2014, Monday, the patient reported that her injection site was swollen to about the size of a tennis ball and the surrounding area was a "light pink". She showed her injection site to the reporter who said the injection area was warm and elongated that "looks like cellulitis". On 11-NOV-2014, patient's injection site was "30% more inflamed". She did not seek for medical attention nor received treatment. No rash was observed. At the time of the report the patient had not recovered from the events. The relationship between the adverse effects and the therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Malaise, Pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to his 60 year old female aunt. The reporter stated that he was not familiar with his aunt's medical history but appeared to be diabetic, no known drug allergies. His aunt reported to him that on 08-NOV-2014 she was vaccinated with a dose of ZOSTAVAX (Lot no. K009198, exp. 27-SEP-2015), subcutaneously in the upper arm. On 09-NOV-2014 the patient injection site felt sore and also experienced malaise, body ache and headache. On 10-NOV-2014, Monday, the patient reported that her injection site was swollen to about the size of a tennis ball and the surrounding area was a "light pink". She showed her injection site to the reporter who said the injection area was warm and elongated that "looks like cellulitis". On 11-NOV-2014, patient's injection site was "30% more inflamed". She did not seek for medical attention nor received treatment. No rash was observed. At the time of the report the patient had not recovered from the events. The relationship between the adverse effects and the therapy with ZOSTAVAX was not reported. 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 health care professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of VAQTA, (dose, route, lot number and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. On 10-NOV-2014 the patient was vaccinated with an expired dose of MMR II (lot # not reported, expiration date 18-OCT-2014), 0.5 ml, subcutaneously. No adverse events were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL, (dose, route, lot number and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, (dose, route, lot number and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, refers to unspecified patiens of unkonwn age and gender. No pertinent medical history was reported. On an unknown date, unspecified patients were administered GARDASIL (strength, dose, route, lot# were not reported) which were exposed to temperatures of 10 degrees Celsius for 7 hours and 45 minutes. No adverse events were reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a Office Manager via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, route not reported, dose reported as 1 injection). Concomitant medications were unspecified. On an unknown date the patient had "a bad adverse experience" (details unspecified) after receiving PNEUMOVAX 23. The patient did not seek medical attention. The outcome of the event was unknown. 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 health care professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of MMR (manufacturer unknown), (dose, route, lot number and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Skin warm
Clinical narrative: This spontaneous report as received from an 83 year old female consumer with penicillin allergy and sulfa allergy referring to herself. The patient's medical history included breast cancer. Historical therapies included ZOSTAVAX (Merck) on an unknown date in 2013 (also reported as last year). On 27-OCT-2014 the patient was vaccinated, at her physician's office, with PNEUMOVAX 23, 1 injection, in the right arm (dose, dose number, route, lot number and expiration date were not reported). Concomitant therapies included influenza virus vaccine (unspecified) (also reported as annual flu vaccine) on the left arm (also reported as the opposite arm) and a lot of miscellaneous prescription tablets and capsules. On 29-OCT-2014, patient experienced rash, redness and "puffiness" along with intense itching sensation on her right arm, where she was injected with the PNEUMOVAX 23. The patient stated that the area was hot to the touch. The patient went to the physician's office on 03-NOV-2014 (also reported as yesterday) and was told to out heat on the area. The patient also stated that her obstetrician and gynaecologist (OBGYN) told her to take BENADRYL and apply cold compresses. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 58 year old female licensed practical nurse, reporting on herself, with asthma, congestive obstructive pulmonary disease (COPD), cramping, diarrhea and flushing all over the body to penicillin, hypothyroidism and drug reaction/allergy to sulfur. On 06-NOV-2014 the patient was vaccinated the second dose of PNEUMOVAX 23 (lot number not reported, expiration date 29-FEB-2016)(dose lot number and route were not reported) in the arm. Concomitant therapies includes bunchu, juniper, parsley, potassium gluconate, BASIC WATER PILL, thyroid, asthma and COPD unspecified therapies. Historical drug includes the first dose of PNEUMOVAX 23 in October 2005. Licensed practical nurse reported she was admitted to the Hospital on 05-NOV-2014, for asthma exacerbation (MARRS 1411USA009421). Licensed practical nurse reported she was due for second PNEUMOVAX 23 shot and was administered it about "5 inches below my deltoid in the biceps area" on 06-NOV-2014. Licensed practical nurse reported the muscle in her arm was"killing her and killing her up her neck, shoulder, and on the left back side of her scapula". Licensed practical nurse reported her arm was swollen and it felt "knotted, intense and hurts really bad". Licensed practical nurse reported pain got worse and worse every day. Nurse reported she was discharged from the hospital on 08-NOV-2014. Licensed practical nurse reported she put ice on the area but it made the pain worse and so she applied heat. Nurse reported TYLENOL and ibuprofen did not help the pain. The licensed practical nurse reported she went to see her nurse practitioner last week who prescribed ULTRAM which did not really help but eased the pain. At the time of the report the outcome was reported as not recovered. Patient did not performed lab diagnostic studies. Patient sought medical attention. This is one (1) of two (2) reports from the same patient. Additional information has been requested.
Age: 1.45
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 month old patient of unknown gender. On 11-NOV-2014, the patient was vaccinated with a 0.5 ml dose of PROQUAD (Merck), subcutaneous (lot # and expiration date were not provided). Other suspect vaccine also administered on 11-NOV-2014 included a 0.5 ml dose of VARIVAX (Merck), subcutaneous (lot # and expiration date were not provided). On 11-NOV-2014, the patient received PROQUAD (Merck) and inadvertently received VARIVAX (Merck) at the same office visit. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning to a 19 years old male patient. On an unspecified date from 15-OCT-2014 through 27-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot # K009811, expiration date: 19-JUN-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
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 a patient of 5 years old child patient and unknown gender. On 11-SEP-2014 the patient was vaccinated with (Merck) VARIVAX (lot J009002, expiration date 19-JUL-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 9 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Age: 7.0
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 a patient of 7 years old child patient and unknown gender. On 29-AUG-2014 the patient was vaccinated with PROQUAD lot # K006771, expiration date 19-JUL-2015) (dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 9 doses left of this lot number. This is one of several reports received 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 Licensed Practical Nurse refers to a patient of 4 years old child patient and unknown gender. On 03-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot # K006771, expiration date 07-NOV-2015) (dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received 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 Licensed Practical Nurse refers to a patient of 4 years old child patient and unknown gender. On 09-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot # K006771, expiration date 07-NOV-2015) (dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received 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 Licensed Practical Nurse refers to a patient of 4 years old child patient and unknown gender. On 02-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot # K006771, expiration date 07-NOV-2015) (dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, refers to 4 patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, four patients were administered improperly stored doses of PNEUMOVAX 23 (dose 0.5 ml after the temperature excursion reported on 22-SEP-2014. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
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 gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received 27-OCT-2104 from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 18, units not reported) of unknown gender. On 13-NOV-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient received first dose of GARDASIL (dose, frequency and route were not reported) on 22-JUL-2014. On an unknown date in 2014, the patient received third dose of GARDASIL 3 weeks after receiving the second dose of GARDASIL. No adverse effects reported. No product quality complaint was reported for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown demographics. On 21-OCT-2011, the patient was vaccinated with the first dose of GARDASIL (dose and route unspecified). The patient received the second and third dose of GARDASIL on 21-DEC-2011 and 04-MAY-2012 respectively. The health care worker reported that the patient received the fourth dose of GARDASIL on 25-NOV-2014. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, unspecified patients were administered single dose vials of PNEUMOVAX 23 (strength, route, lot# were not reported) which were exposed to one cycle of 1 C for 48 hours. No adverse events were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a 63 year old female consumer refers to herself (demographics not provided). On 20-NOV-2014 the patient was vaccinated with ZOSTAVAX (dose, lot# and expiration date were not reported). On 20-NOV-2014 the patient "experienced soreness in her arm at the injection site, after receiving ZOSTAVAX". There was no treatment given for the event. The patient did not seek any medical attention. At the time of the report, the outcome of the event was not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected, because there was no patient's or physician's contact information.
Age: 11.0
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 gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received 27-OCT-2104 from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 11, units not reported) of unknown gender. On 12-NOV-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Age: 1.1
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 a patient of 13 months old child patient and unknown gender. On 09-SEP-2014 the patient was vaccinated with a PROQUAD (Merck) (lot K006771, expiration date 07-NOV-2015) (dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received 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 Licensed Practical Nurse refers to a patient of 4 years old child patient and unknown gender. On 05-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot # K006771, expiration date 07-NOV-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reproter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to two patients of unspecified age and gender. On an unknown dates, the patients were vaccinated with doses of GARDASIL (0.5 ml, intramuscularly, anatomical location, lot# and exp.date were not reported) that underwent a temperature excursion. no adverse effect was reproted. The outcome of the event was unknown. 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 Licensed Practical Nurse refers to a patient of 4 years old child patient and unknown gender. On 12-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot # K006771, expiration date 07-NOV-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Computerised tomogram normal, Nuclear magnetic resonance imaging normal, X-ray normal
Clinical narrative: This spontaneous report as received from a female consumer of unknown age. The patient's medical history included liver infection and current conditions were not reported. On 14-OCT-2014 the patient was vaccinated with ZOSTAVAX (strength, dose and frequency not reported). Other co-suspects are not reported and concomitant medication includes unspecified blood pressure pills. On an unknown date, after a couple of days after the vaccination, the patient experienced unexplained severe back pain. It was reported that he went to see his physician and she sent him to have an MRI, CT scan and X-rays of his back, on an unspecified date, which all came back inconclusive. Consumer reports that he was prescribed hydrocodone with acetaminophen 5 mg/325 mg to treat the pain, and will also be seeing an unspecified rehabilitation specialist on 12-NOV-2014 (reported as tomorrow). Consumer also reports that his back began to feel better on an unspecified date (also reported as now seems to be getting worse again. The outcome of experience unexplained severe back pain was reported as not recovered/not resolved. The relatedness of the event with the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Age: 1.05
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 a patient of 12 months old infant patient and unknown gender. On 09-SEP-2014 the patient was vaccinated with a PROQUAD (Merck) (lot K006771, expiration date 07-NOV-2015) (dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 year old patient of unknown gender. On 14-NOV-2014 the patient was inadvertently received a dose of ZOSTAVAX (lot# reported as J009992, dose, dose# and route unspecified) in error. The patient was scheduled to receive (Merck) VARIVAX. No dose of (Merck) VARIVAX was administered. No adverse effects reported. The outcome of the event was not 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 a licensed nurse practitioner refers to multiple unspecified patients of unknown age and gender. On 01-OCT-2014 the patients were vaccinated with (Merck) VARIVAX (dosing details unknown). The reporter stated that she had a supported temperature excursion that affected (Merck) VARIVAX. Reporter stated that she presumed she had administered to multiple unspecified patients since the first excursion date, on 01-OCT-2014, but had no patient or product specific information to offer. No adverse effects were noted. Outcome of the temperature excursion of (Merck) VARIVAX was unknown. No product quality complaint was involved. This is one of the several cases received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. No relevant medical history of the patient was reported. On an unknown date the patient was vaccinated with dose 2 RECOMBIVAX HB 2.5 microgram/0.5 ml injection (lot number, expiration date and route of administration were not reported, Thimerosal Content was not specified). It was reported that the patient received her RECOMBIVAX HB injection 4 months after her first dose of RECOMBIVAX HB. There were no concomitant medications reported. There were no adverse effects reported. There was no product quality complaint involved. The outcome was unknown. 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 nurse practitioner refers to multiple unspecified patients of unknown age and gender. On 01-OCT-2014 the patients were vaccinated with VAQTA (dosing details unknown). The reporter stated that she had a supported temperature excursion that affected VAQTA. Reporter stated that she presumed she had administered to multiple unspecified patients since the first excursion date, on 01-OCT-2014, but had no patient or product specific information to offer. No adverse effects were noted. Outcome of the temperature excursions of VAQTA was unknown. No product quality complaint was involved. This is one of the several cases 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 nurse practitioner refers to multiple unspecified patients of unknown age and gender. On 01-OCT-2014 the patients were vaccinated with GARDASIL (dosing details unknown). The reporter stated she had supported temperature excursion that affected GARDASIL. Reporter stated that she presumed she had administered to multiple unspecified patients since the first excursion date, on 01-OCT-2014, but had no patient or product specific information to offer.  No adverse effects were noted. Outcome of the temperature excursion of GARDASIL was unknown. No product quality complaint was involved. This is one of the several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 27-OCT-2014, the patient was vaccinated with (Merck) VARIVAX, 0.5 ml, subcutaneously, (anatomical location, lot# and exp. date were not reported), which underwent a supported temperature excursion. No adverse experience was reported. The outcome of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to multiple unspecified patients of unknown age na gender. On 01-Oct-2014 the patients were vaccinated with RECOMBIVAX HB (dosing details unknown). The reporter stated that she had a supported temperature excursion that affected ROCOMBIVAX HB. Reporter stated that she presumed she has administered to multiple unspecified patients since the first excursion date, on 01-OCT-2014, but had no patient or product specific information to offer. No adverse effects were noted. Outcome of the temperature excursion of RECOMBIVAX HB was unknown. No product quality complaint was involved. This is one of the several cases received 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 Licensed Practical Nurse refers to a patient of 4 years old child patient and unknown gender. On 05-SEP-2014 the patient was vaccinated with (Oka/Merck) PROQUAD (lot # K006771, expiration date 07-NOV-2015) (dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient with no drug reactions/allergies. On 05-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose, route, frequency and lot number not provided) at her unspecified physician's office. On an unspecified date following vaccination in November 2014, the patient experienced redness, tenderness and a burning sensation at the injection site and tenderness at the injection site, injection site unspecified. The reporter stated that the patient denied any rash or lesions being present. The patient did not seek medical attention. The outcomes were reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Accidental overdose, No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 12-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 (dose/frequency one single 0.5ml injection, lot number and route not provided). The prefilled syringes "started leaking between the needle and the base." A new prefilled syringe was used for the patient. Due to the fact that the syringe was in the patient's arm at the time of the leaking, there was a chance that the patient had already received some of the vaccine before another prefilled syringe was used; therefore, a misuse adverse event was filed. No adverse reactions were reported to the physician by the patient. Product quality control (PQC) was involved. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age. On an unknown date, the patients were vaccinated with (Merck) VARIVAX, 0.5 ml/ once, subcutaneously (lot number not provided), which was exposed to temperatures outside of recommended condition and no adverse events were reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to unspecified patients of unknown age. On an unknown date, the patients were vaccinated with (Oka/Merck) PROQUAD (dose, frequency, route and lot number not provided), which was exposed to temperatures outside of recommended condition and no adverse events were reported. The outcome was unknown. This is one of several reports received from the same source. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 4 years old child patient and unknown gender. On 29-AUG-2014 the patient was vaccinated with a dose of PROQUAD (Merck) (lot K006771, expiration date 07-NOV-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEP
Symptoms: Crohn's disease, Hepatitis B antibody negative, Hepatitis B surface antibody negative, Weight gain poor
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age. On 01-AUG-2002, 02-OCT-2002 and 02-JUN-2003 the patient received doses of RECOMBIVAXHB)(lot#, dose, route not reported) vaccine series. Concomitant medications included PENTASOL. The consumer reported that the patient was "recently", in appropriately 2014, found to have negative titers for Hepatitis B during a screening for initiation of treatment with immunomodulator drugs for treatment for what appears to be Crohn's disease. The consumer reported that the patient was perfectly health her entire life until February 2014, she got a 'stomach bug,' and it never went away." The consumer stated that, at 11 years old, the patient was "failing to gain weight," but she didn't start to manifest any symptoms of Crohn's disease until "this year", in 2014. Outcome of Crohn's disease was reported as not recovered. Outcome of negative titers for Hepatitis B was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Induration, Swelling
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age and gender. On 18-NOV-2014 the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, dose number, injection site and lot # not reported). On 18-NOV-2014, the patient presented with "excessive swelling and induration" after receiving PNEUMOVAX23. The patient sought medical attention. The outcome of event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dosing details unknown, 19400 PFU), at another pharmacy. Concomitant medications were not reported. On an unknown date the patient experienced an injection site reaction. Outcome of injection site reaction was unknown. Causality assessment was not provided. Product quality complaint was not involved. Additional information is not expected since follow up to this report was declined and no additional information was provided.
Sex: F
Vaccine: HPV4
Symptoms: Nasopharyngitis, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a physician, via field representative, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dosing details unknown). Concomitant medications were not reported. On an unknown date the patient experienced cold-like symptoms, after each dose of GARDASIL. Patient experienced fever, nausea and cold like symptoms and had to stay in bed for a couple of days after each dose of GARDASIL that she received. Patient sought medical attention (unspecified how). Physician decided not to administer the third dose of GARDASIL. The patient was not hospitalized for the events. The experience was not life threatening nor did it cause a significant disability or incapacity. The patient recovered from cold like symptoms, fever and nausea. Causality assessment was not provided. Product quality complaint was not involved. Additional information is not expected, since no further information was provided and physician could not be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Nurse reported that on an unknown date patient had a prescription written for ZOSTAVAX but (Merck) VARIVAX (route and dose unknown) was inadvertently administered to the patient rather than ZOSTAVAX (administered route unknown). No adverse effects reported. The outcome and action taken were not provided. No PQC (Production Quality Control) involved. Additional information has been requested.
Age: 1.06
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 a patient of 12 months old infant patient and unknown gender. On 11-SEP-2014 the patient was vaccinated with a dose of (Oka/Merck) PROQUAD (lot K006771, expiration date 07-NOV-2015) (dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.62
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 a patient of 19 months old child patient and unknown gender. On 04-SEP-2014 the patient was vaccinated with a PROQUAD (Merck) (lot K006771, expiration date 07-NOV-2015) (dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.06
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 a patient of 12 months old infant patient and unknown gender. On 11-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot # K006771, expiration date 07-NOV-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. 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 as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 08-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot # K006771, expiration date 07-NOV-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.