chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 21-MAY-2013, patient received improperly stored VARIVAX dose 1, from batch/lot # 0610AE (expiry date, dose units, route and anatomical location were not specified). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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 as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 07-DEC-2012, patient received improperly stored (Oka/Merck) VARIVAX dose 2, from batch/lot # 0610AE (dose and expiry date unknown) (incorrect product storage). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provided 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information ahs been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 16-MAY-2013, patient received improperly stored VARIVAX dose 1, from batch/lot # 0610AE ( expiry date, dose units, route and anatomical location were not specified), on 05-JUN-2013, patient  received improperly stored VARIVAX dose 2, from batch/lot # 0610AE. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the 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 as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 04-APR-2013, patient received improperly stored VARIVAX dose 1, from batch/lot # 0610AE (expiry date, dose units, route and anatomical location were not specified), on 09-MAY-2013, patient received improperly stored VARIVAX dose 2, from batch/lot # 0610AE (incorrect product storage). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the 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 practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 11-MAR-2013, patient received improperly stored VARIVAX dose 2, from batch/lot # 0610AE (expiry date, dose units, route and anatomical location were not specified). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a nurse via PDC (drug poisoning center) (Manufacturer number: US16-040514) nurse found information on internet refers to 354 out of 359 patients of unknown genders and ages, but 50 years of age and older. These patients' relevant medical histories and past drug histories were unknown. The patients were administered ZOSTAVAX, (dose, frequency, indication, and start dates unknown), via "M (intramuscular)" route in the deltoid region of the upper arm (inappropriate route of drug administration). The lot numbers and expiration dates of the ZOSTAVAX vaccines used are unknown. Concomitant therapy was were not reported. The nurse reported that the patients in this study was reading about received ZOSTAVAX off-label (off label use) via "M" injection. She said that according to the information, it was not uncommon for ZOSTAVAX to be given "IM " and that "IM" administration resulted in fewer injection site reactions. It was unknown if there is relevant lab work. As of 26-AUG-2016, it was unknown if these patients continue on the ZOSTAVAX. The outcome of the events receiving it via "IM" injection, off label use and the injection site reactions was unknown. The causality of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 54 year old male patient. Information regarding patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. Approximately in November 2014, the patient was vaccinated with ZOSTAVAX (dosing details not provided) via subcutaneous route. Pharmacist reported that an unspecified amount of time after the dose was administered, the patient developed a rash at the injection site. Outcome of the event was reported as recovered. Reporting pharmacist had not assessed the causality of the event with respect to ZOSTAVAX. This is one of the 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 nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 13-MAY-2013, the patient was vaccinated with the second dose of VARIVAX lot#: 0610AE which was stored improperly. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On 31-JUL-2012 the patient was vaccinated with first dose of improperly stored VARIVAX lot # 671861/1907AA. On 17-JAN-2013, the patient was vaccinated with second dose of improperly stored VARIVAX lot # 0610AE. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose route and frequency unknown. On 15-MAY-2013, the patient was vaccinated with improperly stored VARIVAX dose 2, lot#:0610AE. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 07-DEC-2012, the patient was vaccinated with improperly stored VARIVAX dose 2, lot#: 0610AE. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 30-JUN-2016, the patient were vaccinated with improperly stored dosed of VAQTA (lot # L015460 with expiration date 20-JUL-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 34.4 Fahrenheit (F) for 18 minutes and 51.5 F for 2 hours 50 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a female patient of an unknown age. The patient's pertinent medical history, concurrent condition and concomitant medication were not reported. On an unspecified date in March 2016, the patient was vaccinated with first dose of GARDASIL, (lot number/expiry date and dose not reported). On 10-AUG-2016 (today), the patient would be vaccinated with her second dose of GARDASIL. No adverse symptoms reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Information has been received from a medical assistant referring to a 13 year old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were reported as none. On 02-AUG-2016, the patient was vaccinated with GARDASIL 9 (intramuscular; dose was unknown). The reporter reported GARDASIL 9 with lot # 1043214 which was not valid for GARDASIL 9 or GARDASIL however lot # L043214 is valid for GARDASIL 9. The patient became very dizzy on the same day. He recovered after about 30 minutes and was fine on 03-AUG-2016 when they called to check on him. No treatment was given. No lab test was performed. The patient did not seek medical attention. The causality was not provided. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Mumps, Parotitis, Polymerase chain reaction positive, Pyrexia, Respiratory symptom
Clinical narrative: This literature market report has been received from the authors of a published literature article, concerning two of 14 students presented with clinical mumps. The patients were university women had no known exposure to the infected male students (captured in MARRS # 1608USA014935 and 1608USA015163). The patients had received 2 doses of MMR (manufacturer unknown) (lot#, dose and route unspecified) vaccinations in childhood. On unknown date, the patients presented with a chief complaint of unilateral parotitis. Fever was the second most common symptom, followed by upper respiratory symptoms. At the time of the initial student health visit, the patients were found to have high mumps immunoglobulin G (IgG) levels of greater than 4 index (positive was >= 1.10) and negative immunoglobulin M (IgM) levels (< 1:20). Both patients had detectable buccal swab mumps virus ribonucleic acid (RNA) reverse transcription polymerase chain reaction (RT-PCR). The outcome of parotitis was unknown. The reporter considered the event to be related to MMR (manufacturer unknown). This is one of several reports received from the same source (linked with MARRS # 1608USA002099, 1608USA014935 and 1608USA015163). Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rubulavirus test positive
Clinical narrative: This literature market report has been received from the authors of a published literature article, concerning two of 14 students presented with clinical mumps. The patients were university women had no known exposure to the infected male students (captured in MARRS # 1608USA014935 and 1608USA015163). The patients had received 2 doses of MMR (manufacturer unknown) (lot#, dose and route unspecified) vaccinations in childhood. On unknown date, the patients presented with a chief complaint of unilateral parotitis. Fever was the second most common symptom, followed by upper respiratory symptoms. At the time of the initial student health visit, the patients were found to have high mumps immunoglobulin G (IgG) levels of greater than 4 index (positive was >= 1.10) and negative immunoglobulin M (IgM) levels (< 1:20). Both patients had detectable buccal swab mumps virus ribonucleic acid (RNA) reverse transcription polymerase chain reaction (RT-PCR). The outcome of parotitis was unknown. The reporter considered the event to be related to MMR (manufacturer unknown). This is one of several reports received from the same source (linked with MARRS # 1608USA002099, 1608USA014935 and 1608USA015163). Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Mumps, Polymerase chain reaction positive, Rubulavirus test positive
Clinical narrative: This literature market report has been received from the authors of a published literature article concerning 10 of 14 students presented with clinical mumps. The patients were male university students aged 19 to 22 years. Nine of them were members of the same sports team; 1 had used the same gym facility as the infected athletes; and 1 was a hall mate of an infected athlete. The patients had received 2 childhood MMR (manufacturer unknown) (lot#, dose and route unspecified) vaccinations. On unknown dates, the patients presented with a chief complaint of unilateral parotitis. Fever was the second most common symptom, followed by upper respiratory symptoms. At the time of the initial student health visit, the patients were found to have high mumps immunoglobulin G (IgG) levels of greater than 4 index (positive was greater than or equal to 1.10) and negative immunoglobulin M (IgM) levels (less than 1:20). All patients had detectable buccal swab mumps virus ribonucleic acid (RNA) reverse transcription polymerase chain reaction (RT-PCR). The outcome of the event was unknown. The reporter considered parotitis to be related to MMR (manufacturer unknown). This is one of several reports received from the same source (linked with MARRS # 1608USA002099, 1608USA014935, 1608USA015164). Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous reports was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 24-AUG-2016, the patient was inadvertently vaccinated with a dose of expired PEDVAXHIB (lot # J014512, expiration date: 12-AUG-2016, dose and route of administration were not provided). No adverse effects were reported. Product quality complaint was not involved. 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 unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 22-AUG-2016, the patients were vaccinated with the doses of improperly stored GARDASIL 9 (lot # M009378, expiration date 23-APR-2018; dose and route were not reported). The vaccines were stored in 35.8 F for one hour and 15 minutes. All the vaccines were supported. 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 has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 19-SEP-2012, patient received improperly stored VARIVAX dose 2, from lot # 0610AE (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports 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 practitioner refers to a patient of unknown age and gender. On 05-MAR-2013, the patient was vaccinated with the first dose of improperly stored (Oka/Merck) VARIVAX, lot#:0610AE, dose route and frequency unknown. On 08-APR-2013, the patient was vaccinated with the second dose of improperly stored (Oka/Merck) VARIVAX dose 2, lot#:0610AE. No adverse effect 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 medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in 2016 (reported as after 29-JUL-2016), the patients received improperly stored (at 0.3 degrees Celsius for a total of five hours and five minutes) doses of GARDASIL lot number L035105, expiration date: 14-MAY-2017 (dose and route of administration 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 has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 16-NOV-2012, patient received improperly stored VARIVAX dose 2, from  lot # 0610AE (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the 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 practitioner refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX, lot#:0610AE, dose route and frequency unknown. On 04-JUN-2013, the patient was vaccinated with improperly stored Oka/Merck) VARIVAX lot # 0610AE, dose 2. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in 2016 (reported as after 29-JUL-2016), the patients received improperly stored (at 0.3 degrees Celsius for a total of five hours and five minutes) doses of ROTATEQ, lot number M014753, expiration date: 07-OCT-2017 and lot number L03853 which was not valid, expiration date: 19-AUG-2017, route of administration defaulted to oral (dose was 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 practitioner refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX, dose route and frequency unknown. On 26-APR-2013, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX  dose 2, lot # 0610AE. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unknown number of unspecified patients of unknown age. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 30-JUN-2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L030868 with expiration date 09-JUN-2018, lot # L035878 with expiration date 11-AUG-2018; dose and route were not reported). It was reported that the vaccine was improperly stored at 34.4 Fahrenheit (F) for 18 minutes and at 51.5 F for 2 hours 50 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (office manager) refers to a 4 year old patient of unknown gender. Information on patient's pertinent medical history was not provided. On 12-AUG-2016, the patient was vaccinated with PROQUAD (lot # M010477, expiry 01-SEP-2017) 0.5 ml, subcutaneous and 0.5ml of VARIVAX (lot # L021211, expiry 10-JUN-2017, route not reported) (Overdose was noted since both vaccine contains varicella virus vaccine live). No adverse effects were reported. No further information was provided. 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 medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapies were not reported. On an unknown date in 2016 (reported as after 29-JUL-2016), the patients received improperly stored (at 0.3 degrees Celsius for a total of five hours and five minutes) doses of RECOMBIVAX HB 2.5/0.5 (units not provided), lot number M006708, expiration date: 02-JUN-2018 (dose and route of administration 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 practitioner refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX, dose route and frequency unknown. On 08/MAR-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX  dose 2, lot#:0610AE. No adverse effect 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: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in 2016 (reported as after 29-JUL-2016), the patients received improperly stored (at 0.3 degrees Celsius for a total of five hours and five minutes) doses of GARDASIL 9 lot number M0111117 and M11117 (both were verified as a not valid lot numbers), expiration date: 07-DEC-2017 (strength, dose and route of administration 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: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue
Clinical narrative: Information has been received from a pharmacist concerning a 53 year old female patient with a drug allergic to morphine. Information regarding pertinent medical history was reported as unknown. Concomitant therapies included metoprolol succinate, tamoxifen, hydrochlorothiazide (manufacturer unknown), PROTONIX, PRAVACHOL and indomethacin (manufacturer unknown). On 26-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # M018593, subcutaneous, expiration date 28-JUN-2017, dose not reported). On 31-JUL-2016, the patient stated that she "felt drained and tired" which started on an unspecified date after being administered ZOSTAVAX. The pharmacist reported "the patient's physician submitted a prescription for the patient on 02-AUG-2016 for a methylprednisolone dose pack and a Z-PACK." The outcome of event was unknown. 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 practitioner refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with first dose of VARIVAX dose route and frequency unknown. On 12-APR-2013 the patient was vaccinated with improperly stored VARIVAX dose 2, lot#:0610AE. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug dispensed to wrong patient, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was administered a dose of PROQUAD subcutaneously, lot # reported as L042812, expiration date 26-APR-2017 (dose not reported) due to human error. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 06-JUN-2013, the patient received improperly stored VARIVAX dose 2, from lot # 0610AE (dose, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. 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 registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 29-AUG-2016, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # M011116, expiration date: 17-JUN-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 1.8 degree Celsius for 7 minutes, 1.9 degree Celsius for 7 minutes and 1.0 degree Celsius for 35 minutes, respectively. The temperature excursion was captured using digital data logger. No prior excursions were reported. 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 has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown). On 22-MAR-2013, the patient received improperly stored  (Oka/Merck) VARIVAX dose 2, from lot # 0610AE (dose, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 13-NOV-2012, patient received improperly stored VARIVAX dose 1, from lot # 0610AE (dose and expiry date unknown). On 12-DEC-2012, the patient received second dose of VARIVAX from lot # 0610AE (dose and expiry date unknown) which was improperly stored. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the 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 has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 21-SEP-2012, patient received improperly stored VARIVAX dose 2, from lot # 0610AE (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 11-MAY-2016, the patients were vaccinated with the improperly stored doses of M-M-R II (lot # L039551, albumin status rHA, expiration date 07-OCT-2017; dose and route were not reported). No adverse effects were reported. M-M-R II was not supported until the labeled expiry. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on the medical history, concurrent conditions and drug allergies of the patient was not reported. On 02-AUG-2016 the patient was vaccinated with improperly stored dose of PROQUAD lot # L051100, expiry date 17-JUN-2017, 0.5 ml, subcutaneously (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. Temperature and time frame at which the administered vaccine was stored was -0.15 degree Centigrade for 5 hours. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse via company representative refers to multiple unspecified patients of unknown age. The patients' pertinent medical history, Drug Reactions/Allergies and concomitant medications were unknown. On an unknown date between 01-JUL-2016 and 05-AUG-2016, unspecified number of patients were vaccinated with GARDASIL 9. The nurse had several patients' who fainted after vaccination. Each person only fainted once. The outcome of the event was unknown. The reporter did not provide the relatedness of the event with GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product quality issue, Syringe issue
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant medications were not reported. It was reported that, on an unspecified date the "plunger rod would not push" while administering a dose of GARDASIL 9 to the patient (lot # L048459, expiry date 22-FEB-2018, dose, strength, dose number, vaccination site, route not provided). No adverse effect was reported. A product quality complaint was filed. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on the medical history, concurrent conditions and drug allergies of the patient was not reported. On 08-AUG-2016 the patient was vaccinated with improperly stored dose of PROQUAD lot # L051100, expiry date 17-JUN-2017, 0.5 ml, subcutaneously. Concomitant medication were not reported. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. Temperature and time frame at which the administered vaccine was stored was -0.15 degree Centigrade for 5 hours. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 08-OCT-2012, the patient received improperly stored VARIVAX dose 2, from lot # 0610AE (dose, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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 has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient received vaccinations with improperly stored VARIVAX dose number 1 on 01-APR-2013, and dose number 2 on 07-MAY-2013, both from lot # 0610AE (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an a patient of unknown age and gender. No information on patient's concomitant medications, pertinent medical history, drug reactions or allergies was reported.  The medical assistant reported that the patient received GARDASIL 9 outside the recommended series schedule. The patient was vaccinated with GARDASIL 9 on following dates: the first dose, lot # L018351, expiration date: 11-AUG-2017 on 10-MAR-2016, the second dose, lot # L026602, expiration date: 19-OCT-2017 on 18-JUL-2016; the third dose, lot # L026602, expiration date: 19-OCT-2017 on 18-AUG-2016 (dose and route of administration were not reported). No adverse effects were 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 registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 29-AUG-2016, the patient was vaccinated with an improperly stored dose of RECOMIBVAX HB injection, lot # L048849, expiration date: 04-FEB-2018, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 1.8 degree Celsius for 7 minutes, 1.9 degree Celsius for 7 minutes and 1.0 degree Celsius for 35 minutes, respectively. The temperature excursion was captured using digital data logger. No prior excursions were reported. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient received vaccine in (R) thigh on 8/16/16. Mother noted swelling of Right thigh on 8/17/16 in the morning, thigh was warm to the touch as well. Patient reported pain in leg. Patient seen in clinic on 8/18/16. One tsp of BENADRYL was given. (R) thigh 28.8cm circumference. Patient had follow up appointment scheduled for  8/19/16 but did not show up. Called patient's mother and she gave a verbal update. Patient was doing better, leg is not as swollen but still warm. Mother thinks BENADRYL helped. Advised mother to give another dose of BENADRYL. No fever and no new symptoms. Follow up appointment scheduled for 8/23/16 in clinic. Follow up call 8/22/16. Patient is doing well, swelling is gone and no more warmth in leg. He is acting normal and no complaints of leg pain. Appointment 8/23/16 - Right thigh was remeasured at 26.3 cm. No redness, swelling or warmth to area. No fever and patient acting normal.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician who received information from a patient, refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with ZOSTAVAX (strength, dose, route and site of administration, lot # and expiry date were not reported). On unknown dates, the patients contracted shingles after receiving ZOSTAVAX. The outcome of event was unknown. The relatedness between the event and ZOSTAVAX was not provided. 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 medical assistant regarding a patient of unknown age and gender. Information on the medical history, concurrent conditions and drug allergies of the patient was not reported. On 08-AUG-2016 the patient was vaccinated with improperly stored dose of VARIVAX lot # L025208, expiry date 07-JUN-2017, 0.5 ml, subcutaneously. Concomitant medication were not reported. No adverse effects were reported. There was no Product Quality Complaint (PQC) involved. Temperature and time frame at which the administered vaccine was stored was -0.15 degree Centigrade for 5 hours. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Erythema, swelling in arm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 05-APR-2013, the patient was vaccinated VARIVAX dose 1, lot # 0610AE (dose, vaccination site, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were reported. Physician reported that an unspecified patient received the first dose in the HPV vaccine series with GARDASIL lot number and expiry date unspecified on an unspecified date and then the same patient received the second dose in the HPV vaccine serious with GARDASIL 9, M011117, expiry date 07-DEC-2017, pm 08-AUG-2016. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 20-MAY-2013, the patient receive improperly stored VARIVAX dose 2, from lot # 0610AE (dose, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. 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 as received from a medical assistant refers to patients of unknown demographics. On unknown dates in 2016 (between 30-JUN-2016 and 20-JUL-2016), the patients were vaccinated with unspecified doses of VARIVAX immunization series (Lot# L048468, expiry date: 02-DEC-2017; Lot# L050956, expiry date: 17-DEC-2017; Lot# L026411, expiry date: 15-FEB-2017) that were improperly stored. Temperature/Time: Multiple excursions between 30-JUN-2016 and 20-JUL-2016. Freezer: maximum 30.6F, cumulative time 96 hours, 51 minutes. Refrigerator: 31.3F minimum/maximum 49.4F for cumulative out of range: 35 hours 9 minutes. Data logger was involved. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with GARDASIL 9, lot no. M020103/ expiration date-15-FEB-2018 (Incorrect product storage). No adverse event was reported. No concomitant medication was reported. The outcome of the vent was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Tenderness
Clinical narrative: TDAP given 8/9/16 for new hire. Employee notified me the following day of significant pain down into the (L) axilla area. Very tender to movement and palpation.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood culture, C-reactive protein, Full blood count, Injection site rash, Pyrexia
Clinical narrative: Developed fever of 103 within 24 hours and rash on posterior left upper thigh. Still with fever up to 103  days post vaccines.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Red blood cell sedimentation rate, Urine analysis
Clinical narrative: Developed fever of 103 within 24 hours and rash on posterior left upper thigh. Still with fever up to 103  days post vaccines.