chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored PROQUAD (Merck) recombinant human albumin (rHA) lot # L045676 with expiration date: 14-JUN-2017 and lot# L045676 with expiration date: 09-MAY-2017 (dose, route of administration and injection site were not reported). No adverse effects were reported. Data logger was involved. Administered doses of PROQUAD (Merck) underwent temperature excursions at 13.9 Fahrenheit degrees for 20 minutes and at 10.8 Fahrenheit degrees for 20 minutes. There was no previous temperature excursion. Product quality complaint (PQC) was not involved. 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 a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 04-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not specified; lot # L035686 and expiration date on 16-FEB-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a physician, as part of a marketing research program, refers to 30 patients of unknown gender, aged between 11 to 22 years old, who were enrolled the program. The patients had no pertinent medical history. On unknown dates the patients were vaccinated with GARDASIL 9 (dose, route and lot # not reported). There was no concomitant medication. The patients complained of burning at injection site (onset dates unspecified). No tests were carried out for diagnosis. The event did not prevent the administration of the second and third dose. The outcome of the event was reported as recovering. The physician considered the event to be related to GARDASIL 9. Additional information is not expected because the physician was not willing to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patients' were vaccinated with improperly stored ROTATEQ (lot # L008057, expiry date 01-DEC-2016). No adverse events were reported. No product quality complaint was involved. This is one of the 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 healthcare worker refers to an unspecified number of patients' of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patients' were vaccinated with improperly stored GARDASIL 9 (lot # L014415, expiry date 25-JUL-2017). Temperature was at minimum 22.5 F to maximum 34.7 F. The temperature excursion occurred from February thru 19-MAR-2016. Time frame was 98 hours cumulatively. There was no previous excursion. No adverse events were reported. No product quality complaint was involved. This is one of the 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 a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 11-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not specified; lot # L035686 and expiration date on 16-FEB-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 09-NOV-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose and route of administration were not specified; lot # L019287, expiration date on 14-SEP-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a female patient of unknown age. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, dose number, anatomical location, lot number and expiration date were not provided). No concomitant medication was reported. Later that night, the patient was admitted to an unspecified hospital for an unspecified reason, while at the hospital, the patient was diagnosed with shingles. The patient did not die. No product quality complaint was involved. The outcome of adverse event and herpes zoster was unknown. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, patients were vaccinated with an improperly stored dose of GARDASIL, lot # L007828, expiry date 02-MAR-2017; lot # K010574, expiry date 08-APR-2017, (dose, frequency and route of administration not reported). No adverse effect reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further details provided. This is one of five reports received from the same reporter. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Cellulitis, Diarrhoea, Headache
Clinical narrative: Information has been received from a registered nurse referring to a 58 year old female patient. There was no pertinent medical  history, concomitant medication or drug allergies/drug reactions reported. On 15-APR-2016 the patient was vaccinated with ZOSTAVAX in the left arm (lot #, dosage and route of administration were not provided) at another unspecified facility. On an unknown date in April 2016 the patient had a 4 inch diameter at the injection site of her left arm, red, hard, hot to touch, and oozing vesicles around it by about one inch. The patient also had temperature of 102F (pyrexia),  joint pain, headache, diarrhea, and a rash on both of her inner thighs. The patient was seen by her health care provider and was being treated with ROCEPHIN, and BACTRIM. The patient was diagnosed with cellulitis. The patient's diarrhea had eased up a bit, but her headache still remained as well as the rash. The outcome of injection site cellulitis, joint pain and pyrexia was not reported. Action taken with ZOSTAVAX was not applicable. The reporter did not provide the casual relationship of the events with ZOSTAVAX. Additional information is not expected since the reporter did not wish to be contacted.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site induration, Injection site vesicles, Injection site warmth
Clinical narrative: Information has been received from a registered nurse referring to a 58 year old female patient. There was no pertinent medical  history, concomitant medication or drug allergies/drug reactions reported. On 15-APR-2016 the patient was vaccinated with ZOSTAVAX in the left arm (lot #, dosage and route of administration were not provided) at another unspecified facility. On an unknown date in April 2016 the patient had a 4 inch diameter at the injection site of her left arm, red, hard, hot to touch, and oozing vesicles around it by about one inch. The patient also had temperature of 102F (pyrexia),  joint pain, headache, diarrhea, and a rash on both of her inner thighs. The patient was seen by her health care provider and was being treated with ROCEPHIN, and BACTRIM. The patient was diagnosed with cellulitis. The patient's diarrhea had eased up a bit, but her headache still remained as well as the rash. The outcome of injection site cellulitis, joint pain and pyrexia was not reported. Action taken with ZOSTAVAX was not applicable. The reporter did not provide the casual relationship of the events with ZOSTAVAX. Additional information is not expected since the reporter did not wish to be contacted.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse referring to a 58 year old female patient. There was no pertinent medical  history, concomitant medication or drug allergies/drug reactions reported. On 15-APR-2016 the patient was vaccinated with ZOSTAVAX in the left arm (lot #, dosage and route of administration were not provided) at another unspecified facility. On an unknown date in April 2016 the patient had a 4 inch diameter at the injection site of her left arm, red, hard, hot to touch, and oozing vesicles around it by about one inch. The patient also had temperature of 102F (pyrexia),  joint pain, headache, diarrhea, and a rash on both of her inner thighs. The patient was seen by her health care provider and was being treated with ROCEPHIN, and BACTRIM. The patient was diagnosed with cellulitis. The patient's diarrhea had eased up a bit, but her headache still remained as well as the rash. The outcome of injection site cellulitis, joint pain and pyrexia was not reported. Action taken with ZOSTAVAX was not applicable. The reporter did not provide the casual relationship of the events with ZOSTAVAX. Additional information is not expected since the reporter did not wish to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, patients were vaccinated with an improperly stored dose of RECOMBIVAX HB, lot # L045117, expiry date 06-OCt-2018; lot # L004754, expiry date 10-NOV-2016; lot # L020157, expiry date 12-MAR-2018; lot # L001626, expiry date 06-OCT-2016; lot # K023863, expiry date 03 APR-2016 (dose, frequency and route of administration not reported). No adverse effect reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further details provided. This is one of five 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 was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, patients were vaccinated with an improperly stored dose of VAQTA, lot # L043209, expiry date 17-SEP-2017; lot # L002717, expiry date 02-JUN-2017; lot # L013380, expiry date 04-NOV-2017; lot # L004439, expiry date 15-FEB-2016, (dose, frequency and route of administration not reported). No adverse effect reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further details provided. This is one of five reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 12-APR-2016 the patient was inadvertently administered ZOSTAVAX (lot # L000449, dose, strength and route unknown) that had expired on 08-MAR-2016. No adverse effects reported. Additional information is not expected as the physician refused to be contacted.
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. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact doses, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 30-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot number reported as L07560, expiration date: June 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
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. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact doses, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 28-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot number reported as L07560, expiration date: June 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Age: 48.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist referring to a 48 year old patient of unknown gender. The patient had no  history of chickenpox and history of negative varicella titers. On an unknown date, the patient presented a prescription written simply for varicella vaccine. So based on the patient's age, the pharmacist decided to administer a dose of ZOSTAVAX (dose, route and lot # were unknown) (inappropriate schedule of drug administration). It was then discovered the patient's physician intended for the patient to receive (Oka/Merck) VARIVAX (wrong drug administered). No adverse effect was reported. No product confusion reported. Additional information is not expected as the reporter declined to participate in adverse event collection process.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 20 patients of unknown age and gender. The patients' medical history was not reported. On unknown dates, between 12-AUG-2015 and 12-FEB-2016, the patients were vaccinated with doses of improperly stored ZOSTAVAX (lot # L021608, expiration date reported as 10-SEP-2016, dose and route of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. Additional information is not expected because the reporter cannot be contacted.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from healthcare student refers to a 26 year old female patient. None pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 21-MAR-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # L006547 (expiry date: 04-MAR-2017), (dose not reported) intramuscularly. On 21-MAR-2016, patient experienced "generalized arm pain" and "limited mobility" in the left arm following the first dose administration in the series of three of GARDASIL 9 on the same day 21-MAR-2016. As a corrective therapy, patient took ibuprofen unspecified dose. The patient sought medical attention (unknown type). None lab diagnostics studies performed. The patient did not recover from the events. The reporter did not provide any causality assessment between events and GARDASIL 9. 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 healthcare worker refers to unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored (Merck) VARIVAX lot # L037561 with expiration date: 29-SEP-2017 (dose, route of administration and injection site were not reported). No adverse effects were reported. Data logger was involved. Administered doses of (Merck) VARIVAX underwent temperature excursions at 13.9 Fahrenheit degrees for 20 minutes and at 10.8 Fahrenheit degrees for 20 minutes. There was no previous temperature excursion. Product quality complaint (PQC) was not involved. 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 a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 10-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not specified; lot # L035686 and expiration date on 16-FEB-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were 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 a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 09-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not specified; lot # L035686 and expiration date on 16-FEB-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No patients' medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patients were vaccinated with a doses of M-M-R II (lot number: L028273, expiration date: 28-JUL-2017, albumin status: RHA: lot number: L004658, expiration date: 11-FEB-2017, albumin status: RHA (dates, doses and routes not reported), that was improperly stored. The vaccine was stored in temperature of 1.7 Celsius degree (C) for two  hours and 5 minutes and in 1.7 C for 2 hours and 15 minutes. There was no previous temperature excursion. The excursion was captured with the use of Digital  Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as the nurse did not wish to be contacted.
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. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact doses, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 12-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot # K016966, expiration date: May 2016. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (dose, unit and route not reported, lot # L042846 with expiration date 15-SEP-2017 and lot # L029631 with expiration date 14-AUG-2017). The vaccines were exposed to 34 F for 30 minutes, previous temperature excursion included 55 F for 16 hours and 34 F for 2 hours. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Anger, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling to entire upper right arm, pain. Unusual behavioral problems, intense anger; says he is going to "kill my baby sister." This is unusal for this child.
Age: 1.25
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Mom noted redness swelling and induration to her right thigh that she believed to be from a bug bite. Pt was seen in the office on 4/21/16.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. The medical history, concurrent condition and concomitant medications were not reported. On an unknown date in 2006, the patient was vaccinated with VARIVAX (Merck) (lot# not reported) dose 1. On an unknown date, the patient experienced negative titers. On 31-MAR-2016, the patient was vaccinated with VARIVAX (Merck) (lot# not reported) dose 2. The outcome of the event was unknown. Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 6 month old male patient. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with ROTATEQ, dose 1, oral. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA (dose, unit and route not reported, lot # L048460 with expiration date 14-JAN-2017 and lot # K012457 with expiration date 04-JUN-2017). The vaccines were exposed to 34 F for 30 minutes, previous temperature excursion included 55 F for 16 hours and 34 F for 2 hours. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The medical history, concurrent condition and concomitant medications were not reported. On 07-APR-2016, the patient was vaccinated with an expired dose of PEDVAXHIB (lot # J006416, Expiry: 25-FEB-2016). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On 30-MOV-2015, the patient was vaccinated with a dose of M-M-R II (dose and route of administration were not specified: lot # K011317, expiration date on 13-AUG-2016) that "might" have been improperly stored (it was unknown) if the vaccines underwent a temperature excursion). 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 healthcare professional regarding unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were unknown. The reporter stated that since 01-OCT-2015 till December 2015, unspecified number of patients were vaccinated with improperly stored VARIVAX lot # L018002 expiration date 19-MAY-2017 (route, site of administration, dose unknown). The vaccine was stored at unknown temperatures exceeding 46 F for an unspecified duration. There was no previous temperature excursion. This was not part of any digital data logger. The reporter was not aware of any adverse effects. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Burning sensation, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old female patient. The patient had a history of shingles 10 years ago. She was allergic to sulfa drugs. Information regarding her concurrent conditions were not provided. On 18-MAR-2016, the patient was vaccinated with ZOSTAVAX (lot # L035506, expiry date: 16-DEC-2016). Concomitant therapy included unspecified chronic medications. Pharmacist reported that the patient developed burning and itching of her lower extremities and abdomen within 24 hours of vaccination. The patient did not required  medical attention. Pharmacist stated that he patient's symptoms occurred off and on since she received the vaccination. She self administered Advil, Benadryl and Aleve on unknown dates, for the treatment of her symptoms. Reporting pharmacist stated that they were unknown if rash was present and also mentioned that the patient did not reported a rash. Outcome of the events were unknown. Reporting pharmacist did not assessed the causality of the events with respect to therapy with ZOSTAVAX.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 23-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not specified; lot # L035686 and expiration date on 16-FEB-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact doses, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 08-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot # K016966, expiration date: June 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 07-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not specified; lot # L035686 and expiration date on 16-FEB-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). 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 healthcare worker refers to an unspecified number of patients' of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (lot # L023588, expiry date 26-JUN-2017). Temperature was at minimum 6.7 F to maximum 9.2 F. The temperature excursion occurred from 14-MAR-2016 thru 27-MAR-2016. Time frame of excursion was 40 hours and 52 minutes cumulatively. There was no previous excursion. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Induration and erythema at injection site, started 1 day after injection, and increasing in size on day 4. No cellulitis.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unspecified dates, multiple unspecified number of patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L019286, expiry date 14-SEP-2017 and lot # L014198, expiry date 05-SEP-2017) dosage regimen and route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. This report 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 certified medical assistant refers to multiple unspecified patient of unknown age and gender. Information regarding the patients current condition and medical history was not provided. On an unknown dates the patients were vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (dosing regimen unspecified) lot # L018001, expiry date 19-MAY-2017. No adverse effects were reported. The call was the result of a data logger. No previous temperature excursions were present. The temperature excursion included 14F for 127 hours and 15.1F for 22.5 hours. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of the two cases from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician referring to a 4 year old patient of an unknown gender. The patient's concurrent conditions and medical history were not reported. On 08-APR-2016, the patient was inadvertently vaccinated with a dose of ZOSTAVAX, 0.5 ml (dose number, anatomical location, route, lot number and expiration date were not provided) instead of a dose of (Oka/Merck) VARIVAX (dose number, anatomical location, route, lot number and expiration date were not provided). Concomitant therapies were not provided. On an unknown date, the patient experienced fever (pyrexia).  No product quality complaint PQC was involved. The outcome of pyrexia was unknown The reporter did not assess the relatedness between pyrexia and suspect therapy. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple unspecified patient of unknown age and gender. Information regarding the patients current condition and medical history was not provided. On an unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dosing regimen unspecified) lot # L024122, expiry date-30-DEC-2016. No adverse effects were reported. The call was the result of a data logger. No previous temperature excursions were present. The temperature excursion included 14F for 127 hours and 15.1F for 22.5 hours. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of the two cases 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 Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unspecified dates, multiple unspecified number of patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L024132, expiry date 21-JAN-2017) dosage regimen and route unknown. Concomitant medications were not reported. On an unknown date in November 2015, the vaccine was subjected to a temperature excursion of -1.5C for a time frame of 10 hours and 45 minutes. On an unknown date in December 2015, the vaccine was subjected to a temperature excursion of -0.6 C for a time frame of 10 hours and 30 minutes. On an unknown date in January 2016, the vaccine was subjected to a temperature excursion of -199.9 C for a time frame of 7 hours, 15 minutes, and -29 C for a time frame 12 hours and 15 minutes. On an unknown date in February 2016, the vaccine was subjected to a temperature excursion of -1.6 C for a time frame of 10 hours. On an unknown date in March 2016, the vaccine was subjected to a temperature excursion of -1.6C for a time frame of 9 hours and 30 minutes. On an unknown date in April 2016, the vaccine was subjected to a temperature excursion of -6.2 C for a time frame of 6 hours. No adverse effects were reported. Product quality complaint (PQC) was not filed. This report is one of the 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: This spontaneous report as received from Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unspecified dates, multiple unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (therapy type unknown) (lot # L044917, expiry date 05-OCT-2018) dosage regimen and route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. This report is one of the several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Amnesia, Fatigue, Hypoaesthesia
Clinical narrative: This spontaneous social media report as received from a registered nurse via a company representative refers to a 16 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. The nurse saw the information on the patient's mother's social media page. On an unknown date, the patient was vaccinated with unidentified Merck HPV vaccine (name and lot number not provided). On an unknown date, the patient experienced fatigue, memory loss and numbness in her legs after getting the vaccine. It was not reported how many doses of the vaccine the patient received. On an unknown date, the patient went to hospital for neurology tests and blood work. The reporter did not know if she was admitted or not. The outcome of the events was unknown. The relatedness between the events and the suspect therapies was not provided. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknon age and gender. The patient's pertinent medical history, drug allergies/reactions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX (lot # L036823, expiry date 24-DEC-2016). The vaccine was exposed to a temperature of 34 Fahrenheit for 5 hours. No adverse event was reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unspecified dates, multiple unspecified number of patients were vaccinated with improperly stored doses of VAQTA (lot # L032749, expiry date 04-NOV-2016; lot # L013324, expiry date 24-APR-2017 and lot # L031196, expiry date 05-FEB-2017) dosage regimen and route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. This report is one of the 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 physician referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On unspecified dates, the patients were administered improperly stored PROQUAD (Merck) Lot number L050908 with expiration date of 14-JUN-2017 and L044055 with expiration date of 02-MAY-2017, (dose and route were not reported), which were stored at 7.9 F for 12 hours, 10.6 F for 12 hours, 6.8 F for 12 hours and 6.8 F for 12 hours, the worst case scenario was 48 hours cumulatively. The vaccines did not have previous temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 16-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not specified); lot # L035686 and expiration date on 16-FEB-2017 that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.6
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 month old patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patient was administered 2 doses of M-M-R II, injection (dose, route of administration, lot # and expiration date were not reported) at 2 different office visits. The same patient was then administered an additional 2 doses of M-M-R II at 2 different office visits (on unspecified dates) when the patient was 3 years old. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 06-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not specified; lot # L035686 and expiration date on 16-FEB-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were 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: This spontaneous report as received from Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unspecified dates, multiple unspecified number of patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L025204, expiry date 07-JAN-2017) dosage regimen and route unknown. Concomitant medications were not reported. On an unknown date in November 2015, the vaccine was subjected to a temperature excursion of - 6.5 degrees C for a time frame of 14 hours and 15 minutes. On an unknown date in December 2015, the vaccine was subjected to a temperature excursion of - 6.9 degrees C for a time frame of 14 hours and 45 minutes. On an unknown date in January 2016, the vaccine was subjected to a temperature excursion of - 8.8 degrees C for a time frame of 14 hours and 30 minutes. On an unknown date in February 2016, the vaccine was subjected to a temperature excursion of - 1.6 degrees C for a time frame of 10 hours. On an unknown date in March 2016, the vaccine was subjected to a temperature excursion of - 1.8 degrees C for a time frame of 8 hours. On an unknown date in April 2016, the vaccine was subjected to a temperature excursion of - 199.9 degrees C for a time frame of 15 minutes. No adverse effects were reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. This report is one of the several reports received from the same reporter. Additional information has been requested.