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 referring to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions, medical histories and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (Lot # M010485, expiration date 01-MAR-2018) dose, route, anatomical location and frequency were unknown. Temperature excursions and times were reported as follows: -9.6C for 2 hours and 11 minutes, 6.6C for 5 hours and 33 minutes and -4.3C for 8 hours and 30 minutes. Data logger was reported as yes. 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 healthcare worker referring to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions, medical histories and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (Lot # M006105, expiration date 01-AUG-2017) dose, route, anatomical location and frequency were unknown. Temperature excursions and times were reported as follows: -9.6C for 2 hours and 11 minutes, -6.6C for 5 hours and 33 minutes and -4.3C for 8 hours and 30 minutes. Data logger was reported as yes. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 28-MAR-2005, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml, intramuscularly, with a reported lot # M0011840 with expiration date 01-FEB-2018 (anatomical route of vaccination was not provided). The patient's concomitant medications were not reported. The office manager stated, that the vaccine temperature excursion had a time frame of 72 hours at 34 degrees F. Data logger was involved. However, no side effects were noted. GARDASIL 9 was not involved on a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 29-APR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L033548 with expiration date 14-MAY-2017 (strength and dose number were not provided). The patient's concomitant medications were not reported. The office manager stated that, the vaccine temperature excursion had a time frame of 72 hours at 34 degrees F. Data logger was involved. However, no side effects were noted. ROTATEQ was not involved on a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 22-APR-2016, The patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L033548 with expiration date 14-MAY-2017 (strength and dose number were not provided). The patient's concomitant medications were not reported. The office manager stated that, the vaccine temperature excursion had a time frame of 72 hours at 34 degrees F. Data logger was involved. However, no side effects were noted. ROTATEQ was not involved on a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 20-NOV-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot number L022795 with expiration date 05-NOV-2016 (dose, strength and route of administration were not reported). No adverse effects were reported. This is one of two reports from the same source (MARRS 1611USA011835). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurse concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of ROTATEQ lot # L033545, expiration date 30-MAY-2017, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. Temperature: 35F. Time frame: 12 hours. There was a call because of a data logger. There was no a previous temperature excursion. No product quality complaint (PQC) was involved. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 17-NOV-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot number L022795 with expiration date 05-NOV-2016 (dose, strength and route of administration were not reported). No adverse effects were reported. This is one of two reported from the same source (MARRS 1612USA000501). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 05-APR-2005, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml, intramuscularly, with a reported lot # M0011840 with expiration date 01-FEB-2018 (anatomical route of vaccination was not provided). The patient's concomitant medications were not reported. The office manager stated, that the vaccine temperature excursion had a time frame of 72 hours at 34 F. Data logger was involved. However, no side effects were noted. Gardasil 9 was not involved on a previous temperature excursion. 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 was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 19-JAN-2005, the patient was vaccinated with an improperly stored dose of Gardasil 9, 0.5 ml, intramuscularly, with a reported lot # M0011840 with expiration date 01-FEB-2018 (anatomical route of vaccination was not provided). The patient's concomitant medications were not reported. The office manager stated, that the vaccine temperature excursion had a time frame of 72 hours at 34 degrees F. Data logger was involved. However, no side effects were noted. GARDASIL 9 was not involved on a precious temperature excursion. 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 was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 05-SEP-2002, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml, intramuscularly, with a reported lot # M0011840 with expiration date 01-FEB-2018 (anatomical route of vaccination was not provided). The patient's concomitant medications were not reported. The office manager stated, that the vaccine temperature excursion had a time frame of 72 hours at 34 F. Data logger was involved. However, no side effects were noted. GARDASIL 9 was not involved on a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 13 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 14-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M005921, expiration date 02-FEB-2018; site, dose and route of administration were not reported). No adverse effects were reported. This  is one of several reports received from the same source. Additional information is not expected as no further information is available.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 03-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M005921, expiration date 02-FEB-2018; site, dose and route of administration were not reported). No adverse effects were reported. This is of several reports received from the same source. Additional information is not expected as no further information is available.
Age: 1.75
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 21 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 03-NOV-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # M005921, expiration date 02-FEB-2018; site, does and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates approximately in November 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M023169, expiration date 13-JUN-2018, lot # M017983, expiration date 30-MAY-2018, lot # M030380, expiration date 01-FEB-2019 and lot # L019297, expiration date 18-AUG-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of GARDASIL 9 were stored in the temperature of 47.7 degrees Fahrenheit for 45 minutes on 18-NOV-2016, then in the temperature of 47.5 degrees Fahrenheit for 15 minutes, in the temperature of 48.4 degrees Fahrenheit for 30 minutes and in the temperature of 31.6 degrees Fahrenheit for 5.5 hours (1 cycle) on 19-NOV-2016, then in the temperature of 29.7 degrees Fahrenheit for 11 hours (1 cycle) and in the temperature of 33.4 degrees Fahrenheit for 15 minutes (1 cycle) on 20-NOV-2016. Data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (dose and route were unknown; lot # M004894 with expiration dates 26-JUL-2017(recombinant human albumin (rHA)) and lot # L039268 with expiration date 05-APR-2017). The vaccines were exposed under temperature of 5.5 degrees Fahrenheit for 1 hour. The previous temperature excursion was 25.6 degrees Fahrenheit for 13 hours cumulative. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: Information has been received from a physician via a company representative referring to a currently 20 year old female patient. The patient was not pregnant. The patient's medical history and drug reactions/allergies were not reported. Concomitant medication included (unspecified) TDAP and MENACTRA. In approximately 2007, when she was 11 year old, the patient was vaccinated with GARDASIL (lot # and expiration date were unknown, 0.5 ml) intramuscular. It was unknown whether the patient had received her first, second or final dose of the GARDASIL series when she received the dose referenced in this report. After getting the vaccine shot, the patient developed a medical condition called "Postural Orthostatic Tachycardia Syndrome" (date unspecified). Initially, the patient had her follow up visits when she was younger with her primary care physician (the reporter) who was evaluating her symptoms after she had received the shot. After she was officially diagnosed with Postural Orthostatic Tachycardia Syndrome, she began seeing an unknown cardiologist. It was unknown if treatment was given for the event. The outcome of the event was not recovered. The causality was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from the patient's mother concerning her son of unknown age. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. The patient might have received GARDASIL (lot #, expiration date and dose were unknown; intramuscularly) that were not intended for him (Wrong drug administered). It was unclear if the patient received each dose within the series, and at what age the vaccine dose(s) were allegedly administered. The patient had not experienced any specific adverse systems as a result. It could not be confirmed if the patient received doses of GARDASIL at all or if the patient's records contained clerical error that listed him as receiving the vaccine, when in fact he did not. Additional information is not expected as the reporter did not want to be contacted.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Hypersensitivity
Clinical narrative: Information has been received from a pharmacist referring to a 63 year old female patient who was not pregnant. The patient had unspecified thyroid function and unspecified allergic reactions to amlodipine, amoxicillin, codeine, lisinopril (manufacturer unspecified), penicillin, sulfa and iodides. On 16-NOV-2017 the patient was vaccinated with ZOSTAVAX (lot # M034766 with expiration date of 26-OCT-2017, subcutaneous; dosage and frequency unspecified). Concomitant therapies included unspecified thyroid medication and calcium supplement with Vitamin D. On 17-NOV-2016 the patient called the pharmacy to report that she was experiencing an injection site reaction. On 18-NOV-2016, the patient came to the pharmacy and the pharmacist examined the patient's injection site. The pharmacist stated that the injection site area was "really red with a huge welt around the injection site". The pharmacist described an area of "less redness" in a perimeter surrounding the injection site. The patient also reported that the welt and redness had worsened since she first noticed it "yesterday (17-NOV-2016)" and the area was "hot to touch". The patient also reported muscle pain, joint pain, severe headache, congestion, fever, and chills. The patient reported waking up from sleep "in pool of sweat." The patient reported that she was being "shaking and itchy," especially in her ears and neck area. The pharmacist stated, "It looked like an allergic reaction, so the pharmacist instructed her to take BENADRYL." The pharmacist did not know if the patient had taken any BENADRYL, and she didn't know if the BENADRYL was helpful to the patient's adverse symptoms. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The causality was not reported. This is one of 3 reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site urticaria, Injection site warmth, Myalgia
Clinical narrative: Information has been received from a pharmacist referring to a 63 year old female patient who was not pregnant. The patient had unspecified thyroid function and unspecified allergic reactions to amlodipine, amoxicillin, codeine, lisinopril (manufacturer unspecified), penicillin, sulfa and iodides. On 16-NOV-2017 the patient was vaccinated with ZOSTAVAX (lot # M034766 with expiration date of 26-OCT-2017, subcutaneous; dosage and frequency unspecified). Concomitant therapies included unspecified thyroid medication and calcium supplement with Vitamin D. On 17-NOV-2016 the patient called the pharmacy to report that she was experiencing an injection site reaction. On 18-NOV-2016, the patient came to the pharmacy and the pharmacist examined the patient's injection site. The pharmacist stated that the injection site area was "really red with a huge welt around the injection site". The pharmacist described an area of "less redness" in a perimeter surrounding the injection site. The patient also reported that the welt and redness had worsened since she first noticed it "yesterday (17-NOV-2016)" and the area was "hot to touch". The patient also reported muscle pain, joint pain, severe headache, congestion, fever, and chills. The patient reported waking up from sleep "in pool of sweat." The patient reported that she was being "shaking and itchy," especially in her ears and neck area. The pharmacist stated, "It looked like an allergic reaction, so the pharmacist instructed her to take BENADRYL." The pharmacist did not know if the patient had taken any BENADRYL, and she didn't know if the BENADRYL was helpful to the patient's adverse symptoms. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The causality was not reported. This is one of 3 reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Respiratory tract congestion, Tremor
Clinical narrative: Information has been received from a pharmacist referring to a 63 year old female patient who was not pregnant. The patient had unspecified thyroid function and unspecified allergic reactions to amlodipine, amoxicillin, codeine, lisinopril (manufacturer unspecified), penicillin, sulfa and iodides. On 16-NOV-2017 the patient was vaccinated with ZOSTAVAX (lot # M034766 with expiration date of 26-OCT-2017, subcutaneous; dosage and frequency unspecified). Concomitant therapies included unspecified thyroid medication and calcium supplement with Vitamin D. On 17-NOV-2016 the patient called the pharmacy to report that she was experiencing an injection site reaction. On 18-NOV-2016, the patient came to the pharmacy and the pharmacist examined the patient's injection site. The pharmacist stated that the injection site area was "really red with a huge welt around the injection site". The pharmacist described an area of "less redness" in a perimeter surrounding the injection site. The patient also reported that the welt and redness had worsened since she first noticed it "yesterday (17-NOV-2016)" and the area was "hot to touch". The patient also reported muscle pain, joint pain, severe headache, congestion, fever, and chills. The patient reported waking up from sleep "in pool of sweat." The patient reported that she was being "shaking and itchy," especially in her ears and neck area. The pharmacist stated, "It looked like an allergic reaction, so the pharmacist instructed her to take BENADRYL." The pharmacist did not know if the patient had taken any BENADRYL, and she didn't know if the BENADRYL was helpful to the patient's adverse symptoms. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The causality was not reported. This is one of 3 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients  of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (dose and route were unknown; lot # M002064 with expiration date 12-JAN-2018 and lot # L034370 with expiration date 08-AUG-2017). The vaccines were exposed under temperature of 5.5 degrees Fahrenheit for 1 hour. The previous temperature excursion was 25.6 degrees Fahrenheit for 13 hours cumulative. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients. Information about concurrent condition, medical history and drug reactions/allergies was not provided. On unknown dates, the patients were administered improperly stored doses of ROTATEQ (dose was unknown, lot L033545, expiration date 30-MAY-2017, lot # M014544, expiration date 27-NOV-2017) orally. These vaccines were exposed to 0.4 degree centigrade for 6 hours 30 min. A data logger was used to log temperatures and there were no prior excursions. No adverse effects were reported. Additional information has been requested. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative reporting on unspecified number of unknown patients. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot# L037562, expiration date 29-SEP-2017; lot# L012038, expiration date 07-APR-2017 lot# L021215, expiration date 10-JUN-2017; lot# L004655, expiration date 11-FEB-2017; lot#L035124, expiration date 04-FEB-2017; lot# M004326, expiration date 25-JAN-2018; lot# L043624, expiration date 03-NOV-2017 (dose and route of administration were not reported). The administered VARIVAX with lot# L037562, expiration date 29-SEP-2017 and lot# L012038, expiration date 07-APR-2017 was exposed to three separate temperature excursions (dates unspecified): one lasting for 24 hours and 30 minutes with the lowest recorded temperature of - 14 degrees Celsius, the second lasting for 24 hours and 15 minutes with the lowest recorded temperature of -12.7 degrees Celsius and the third lasting for 14 hours with the lowest recorded temperature of -13.7 degrees Celsius. The administered VARIVAX with lot# L021215, expiration date 10-JUN-2017; lot# L004655, expiration date 11-FEB-2017 and lot# L035124, expiration date 04-FEB-2017 was exposed to one temperature excursion (date unspecified) lasting for 32 hours and 30 minutes with the lowest recorded temperature of -13.3 degrees Celsius. The administered VARIVAX with lot# L043624, expiration date 03-NOV-2017 was exposed to one temperature excursion (date unspecified) lasting for 24 hours and 30 minutes with the lowest recorded temperature of -14 degrees Celsius. The administered VARIVAX with lot# M004326, expiration date 25-JAN-2018 was was exposed to two separate temperature excursions (dates unspecified): one lasting for 24 hours and 15 minutes with the lowest recorded temperature of -12.7 degrees Celsius and the second lasting for 14 hours with the lowest recorded temperature of -13.7 degrees Celsius. No adverse event was reported. This is one of two reports from the same reporter. Additional information has been reported.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis
Clinical narrative: Information has been received from a nurse referring to her husband, a 62 year old male patient. Information about concurrent condition, medical history was unknown. The patient had no drug reactions/allergies. On 10-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, lot #, expiration date and route were unknown). On 10-NOV-2016 (reported as about 6 hours ago at the reported time), the patient was dripping wet with diaphoresis. He had no chest pains and had a heart attack in the past so he know this was not chest pains. His heart rate and respirations were normal. The patient did not received treatment for the event. The outcome of the event was  unknown. The causality assessment between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age (reported as a child) and gender. Patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with VARIVAX (dosage regimen. rote of administration, lot # and expiry date unspecified). On an unknown date, the patient experienced shingles. It was reported that the patient's mother, who was 14 weeks pregnant at the time of this report, may have contracted herpes zoster from the patient. The outcome and causality assessment for the event were not provided by the reporter. No product quality complaint (PQC) was involved. No further information was available. 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 registered nurse via a company representative reporting on unspecified number of unknown patients. The patient's medical history, concomitant therapy and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot# M004889, expiration date 25-JUL-2018; lot# M006106, expiration date 01-AUG-2017; lot# L030588, expiration date 10-FEB-2017; lot# L007228, expiration date 03-SEP-2017 (dose and route of administration were not reported). PROQUAD with lot # M004889, expiration date 25-JUL-2018 was exposed to three separate temperature excursions (dates unspecified): one lasting for 24 hours and 30 minutes with the lowest recorded temperature of -14 degrees Celsius, the second lasting for 24 hours and 15 minutes with the lowest recorded temperature of -12.7 degrees Celsius and the third lasting for 14 hours with the lowest recorded temperature of -13.7 degrees Celsius. The administered PROQUAD lot# M006106, expiration date 01-AUG-2017 was stored at -12.7 degrees C for 24 hours and 15 minutes and at -13.7 degrees C for 14 hours. The administered PROQUAD with lot# L030588, expiration date 10-FEB-2017 and lot# L007228, expiration date 03-SEP-2017 was exposed to one temperature excursion (date unspecified) lasting for 32 hours and 30 minutes with the lowest recorded temperature of -13.3 degrees Celsius. No adverse event was reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, an unspecified number of improperly stored doses of GARDASIL 9 (lot # L038503, expiration date 18-DEC-2017, dose and route were unknown) might had been administered to the patients. No adverse effects were reported. The excursion temperature was 31 F with duration of 16 hours and 30 minutes. The call was due to date logger. There was no previous excursion. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, an unspecified number of improperly stored doses of GARDASIL (lot number K010215, expiration date 5-MAY-2017, dose and route were unknown) might had administered to the patients. No adverse effects were reported. The excursion temperature was 31 F with duration of 16 hours and 30 minutes. The call was due to a date logger. There was no previous excursion. This is one of several reports 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 certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 15F for cold temperature and in 51F for warm temperature) doses of GARDASIL 9 (dose, route of administration, lot # an expiration date were not reported. The call was made because of the data logger. No previous excursion and no adverse effects were reported. This is one of two reports received from the same reporter. 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 certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 15F for cold temperature and in 51F for warm temperature) doses of PNEUMOVAX 23 (lot # L019836; dose, route of administration and expiration date were not reported). The call was made because of the data logger. No previous excursion and no adverse effects were reported. This is one of two 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 as received from a medical assistant refers to a patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 28-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # L02214, expiry date: 21-JAN-2017, lot # L040411 (not valid), expiry date: 13-APR-2017) (route: subcutaneous). Medical assistant was not sure which lot number the patient had received. The vaccine was stored at a temperature of -13 degrees C for 156 hours. Data logger was not involved. There was no previous temperature excursion. No symptoms reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients might had been vaccinated with improperly stored VARIVAX (dose and route were unknown; lot # M023383 with expiration date 11-MAY-2018 and lot # M028553 with expiration date 07-JUN-2018). The vaccines were exposed under temperature of 3 degrees centigrade for 13 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients might have been vaccinated with improperly stored PROQUAD (dose and route were unknown; lot # M018635 with expiration date 11-OCT-2017, lot # M021731 with expiration date 29-OCT-2017, lot # M032496 with expiration date 02-JAN-2018 and lot # M031941 with expiration date 27-DEC-2017). The vaccines were exposed under temperature of 3 degrees centigrade for 13 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients. Information about concurrent condition, medical history and drug reactions/allergies was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration were unknown, lot # L033343, expiration date 12-SEP-2017). These vaccines were exposed to 0.4 degree centigrade for 6 hours 30 min (incorrect product storage). A data logger was used to log temperatures and there were no prior excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients. Information about concurrent condition, medical history and drug reactions/allergies was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route of administration were unknown, lot # L038503 with expiration date 18-DEC-2017, lot # M017983 with expiration date 30-MAY-2018, lot # M007764 with expiration date 30-JAN-2018, lot # L036301 with expiration date 20-DEC-2017). These vaccines were exposed to 0.4 degree Centigrade for 6 hours 30 min (incorrect product storage). A data logger was used to log temperatures and there were no prior excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (also an office manager) refers to a male patient of unknown age. No information about the patient's medical history, concomitant medications or concurrent conditions was provided. On 16-NOV-2016, the patient was vaccinated with a primary dose of VARIVAX lot # M027886, with expiry date of 03-JUN-2018, 0.5 ml, intramuscularly in an unknown site. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients. Information about concurrent condition, medical history and drug reactions/allergies was not provided. On unknown dates, the patients were vaccinated with improperly stored of PNEUMOVAX 23 (dose, route of administration were unknown, lot # L019836, expiration date 24-MAR-2017). These vaccines were exposed to 0.4 degree centigrade for 6 hours 30 min. A data logger was used to log temperature and there were no prior excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates in 2016 (reported as "since 03-OCT-2016"), the patients were vaccinated with doses improperly stored PROQUAD (dose and route were unknown; lot # M022402 with expiration date 01-NOV-2017). On 03-OCT-2016, the vaccines were exposed under temperature of 17 degrees Fahrenheit for 8 hours. On 17-OCT-2016, the vaccines were exposed under temperature of 17 degrees Fahrenheit for 8 hours. There were no previous temperature excursion and no data logger. No adverse experiences were reported. No product quality complaint (PQC) was involved. 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: Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown date in 2016 (reported as "since 03-OCT-2016"), the patients were vaccinated with doses of improperly stored VARIVAX (dose and route were unknown; lot # M004662 with expiration date 27-JAN-2018 and lot # M025870 with expiration date 24-MAY-2018). On 03-OCT-2016, the vaccines were exposed under temperature of 17 degrees Fahrenheit for 8 hours. On 17-OCT-2016, the vaccines were exposed under temperature of 17 degrees Fahrenheit for 8 hours. There were no previous temperature excursion and no data Logger. No adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certificated medical assistant and refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. On 02-NOV-2016 or 03-NOV-2016, the patients were vaccinated with an improperly stored dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported). There was no adverse effect reported. The call was made due to digital data logger. The dose of the administered vaccine was exposed to temperature of 9.5 degrees Celsius for 28 hours. The vaccine was exposed to previous temperature excursion. There was no product quality complaint involved. 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 was received from a certificated medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concomitant medication were not reported. On 02-NOV-2016 or 03-NOV-2016, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). There was no adverse effect reported. The call was made due to digital data logger. The dose of the administered vaccine was exposed to temperature of 9.5 degrees Celsius for 28 hours. The vaccine was exposed to previous temperature excursion. There was no product quality complaint involved. This is one of several reports received cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients with unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided.  On unknown dates, an unspecified number of improperly stored doses of ROTATEQ (lot# reported as L042217, expiration date 03-JUN-2017, oral, dose was unknown) might had been administered to the patients. No adverse effects were reported. The excursion temperature was 31 F with duration of 16 hours and 30 minutes. The call was due to date logger. There was no previous excursion. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 10-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M005921, expiration date 02-FEB-2018; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 16 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 19-OCT-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) (VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates approximately in November 2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # M033334, expiration date 11-AUG-2018, lot # M029233, expiration date 09-AUG-2018 and lot # M020926, expiration date 11-AUG-2018 (dose, route and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of RECOMBIVAX HB were stored in the temperature of 47.7 degrees Fahrenheit for 45 minutes on 18-NOV-2016, then in the temperature of 47.5 degrees Fahrenheit for 15 minutes, in the temperature of 48.4 degrees Fahrenheit for 30 minutes and in the temperature of 31.6 degrees Fahrenheit for 15 minutes, in the temperature of 48.4 degrees Fahrenheit for 30 minutes and in the temperature of 31.6 degrees Fahrenheit for 5.5 hours (1 cycle) on 19-NOV-2016, then in the temperature of 29.7 degrees Fahrenheit for 11 hours (1 cycle) and in the temperature of 33.4 degrees Fahrenheit for 15 minutes (1 cycle) on 20-NOV-2016. Data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates approximately in November 2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection, lot # L048680, expiration date 10-JUN-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. The administered doses of PNEUMOVAX 23 were stored in the temperature of 47.7 degrees Fahrenheit for 45 minutes on 18-NOV-2016, then in the temperature of 47.5 degrees Fahrenheit for 15 minutes, in the temperature of 48.4 degrees Fahrenheit for 30 minutes and in the temperature of 31.6 degrees Fahrenheit for 5.5 hours (1 cycle) on 19-NOV-2016, then in the temperature of 29.7 degrees Fahrenheit for 11 hours (1 cycle) and in the temperature of 33.4 degrees Fahrenheit for 15 minutes (1 cycle) on 20-NOV-2016. Data logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concomitant medication were not reported. On 02-Nov-2016 or 03-NOV-2016, the patients were vaccinated with a dose of improperly stored  PEDVAXHIB (dose, frequency, route of administration, lot# and expiration date were not reported). There was no adverse effect reported. The call was made due to digital data logger. The dose of the administered vaccine was exposed to temperature of 9.5 degrees Celsius for 28 hours. The vaccine was exposed to previous temperature excursion. There was no product quality complaint involved. This is one of several reports received from the same reported. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an 18 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 18-OCT-2016, the patient was vaccinated with an improperly stored doses of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.