chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US023372 is an initial spontaneous report received from a medical assistant on 19 Nov 2014. This report refers to a 19 years old male patient. His medical history and concomitant were not reported. He was vaccinated with 0.5 ml intramuscular MENVEO (batch number: M14040) on 17 Nov 2014. It was reported that the administered vaccine was stored below recommended temperature for a week. No adverse events were reported following the inadvertent administration.
Age: 19.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US020466 is an initial spontaneous report received from a pharmacist on 09 Oct 2014 with a follow up information received from a pharmacist on 06 Nov 2014. This case refers to a 19 year old female patient. Past medical history was not reported. Her concomitant vaccination included administration of a dose of FLUVIRIN (batch number: 1411001) at a dose of 0.5 ml intramuscularly on 08 Oct 2014. She was vaccinated with an initial dose of MENVEO (batch number: M13014) intramuscularly at a dose of 0.5 ml on 08 Oct 2014 at 12:16 and the vaccine was reported as expired. No adverse event was reported following this administration error. Follow up information received from a pharmacist on 06 Nov 2014: Updated concomitant vaccination, dose number, route and time of vaccination of suspect vaccine.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US020653 is an initial spontaneous report received from a nurse on 13 Oct 2014. This case refers to a 16 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with an expired dose of MENVEO (batch number: not reported) intramuscularly on 13 Oct 2014. No adverse event was reported following this administration error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US023361, is an initial spontaneous report received from a medical assistant on 19 Nov 2014 and with follow-up information from a medical assistant received on 06 Feb 2015. This report refers to a 12 year old male patient. Historical condition was not reported. No concomitant medication was reported. The patient was inadvertently vaccinated only with the Men-CWY-135 liquid component of MENVEO (batch number: M14068) via intramuscular route into left arm on 19 Nov 2014. The patient was notified to come into clinic for revaccination. No adverse event was reported following this administration error (inappropriate preparation of medication). Follow-up information from a medical assistant received on 06 Feb 2015: Patient's demographics (height and weight) and site of vaccination (left arm) was updated.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024160 is an initial spontaneous report received from a health care professional on 01 Dec 2014. This report refers to an 11 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A13046) intramuscularly at a dose of 0.5 ml on 20 Oct 2014 . It was reported that the vaccine reached 0 to 1 degree C sporadically for 3 days when it was not reconstituted and was subsequently administered to the patient. The reporter stated that the vaccine did not freeze and it was the first occurrence. No adverse events were reported following the maladministration.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US019858 is an initial spontaneous report received from a medical assistant on 01 Oct 2014 and a follow up report from the medical assistant received on 24 Nov 2014. This report refers to a 11 year-old male patient. He was allergic to hydrocodone. He tolerated the previous vaccinations (unspecified). He concomitantly received BOOSTRIX vaccine (other manufacturer) at a dose of 0.5 ml intramuscularly on 16 Sep 2014. On the same date, he was vaccinated with MENVEO (batch number: M14067) intramuscularly in the left arm at a dose of 0.5 ml. It was reported that the patient received MenCYW-135 liquid component of MENVEO and did not received MenA lyophilized conjugate. No adverse events were reported following the maladministration. Follow up report from the medical assistant received on 24 Nov 2014: Added information related to previous vaccination, current condition (allergy), concomitant vaccine (BOOSTRIX) and updated the MENVEO vaccination site.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US020559, is an initial spontaneous report from a health care professional received on 10 Oct 2014. This report refers to a 16-year-old female patient. Past medical history and concomitant medications were not reported. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: unknown) without being reconstituted with Men A lyophilized conjugate component intramuscularly on 06 Oct 2014. No adverse reaction reported following this medication error (inappropriate preparation of medication).
Sex: U
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US014771 is an initial spontaneous report from a nurse received on 21 Jul 2014. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not provided. On an unknown date, the nurse administered MENVEO (batch number: unknown) subcutaneously to a patient instead of intramuscularly. No adverse event reported following this medication error (wrong route of administration).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US014815 is an initial spontaneous report from a nurse received on 23 Jul 2014 with a follow-up received on 25 Aug 2014. This report refers to an 11-year-old male patient. Past medical history was not provided. Concomitant vaccination included TDAP (batch number: FL2P2). The patient received only the Men CYW-135 liquid conjugate component of MENVEO (batch number: A13047) intramuscularly on 22 Jul 2014. No adverse event reported following this medication error (inappropriate preparation of medication). Follow-up received from a nurse on 25 Aug 2014: Concomitant vaccination updated, Batch number of MENVEO amended.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US014952 is an initial spontaneous report received from the physician on 24 Jul 2014. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with a dose of MENVEO (batch number: not reported) intramuscularly on 23 Jul 2014 or on 24 Jul 2014. It was reported that Men A lyophilized conjugate was reconstituted with sterile water instead of the Men CYW-135 liquid conjugate. No adverse event was reported after the maladministration.
Age: 33.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US014956 is an initial spontaneous report from the pharmacist received on 25 Jul 2014. This report refers to a 33 year old male patient. On 07 Jul 2014, the patient was inadvertently vaccinated with Men A lyophilized component of MENVEO (batch number: A13066) reconstituted with sodium chloride solution instead of Men CYW-135 liquid component. No adverse event reported following this medication error (wrong solution used in drug reconstitution).
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US014959 is an initial spontaneous report from the medical assistant received on 24 Jul 2014. This report refers to a 19 year old male patient. On 21 Jul 2014, he was inadvertently vaccinated with only Men CYW-135 liquid component of MENVEO (batch number: X14040) without being reconstituted with Men A lyophilized component. No adverse event reported following this medication error (inappropriate preparation of medication).
Age: 1.02
Sex: M
Vaccine: MMR, RV5, VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse via an office manager and refers to a 12 month old male patient. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 28-APR-2016, the patient was vaccinated with his first dose of VARIVAX injection, lot # L035127, expiry date 14-SEP-2017 (dose, route of administration and anatomical location were not specified) which underwent a supported temperature excursion. Other suspect therapies included the fourth dose of ROTATEQ oral solution, lot # K023532, expiry date 21-JUN-2016 (dose was not specified) on 28-APR-2016, which previously underwent an unsupported temperature excursion. Concomitant therapies included one dose of MMR II. It was unknown if there was any relevant laboratory data. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist via a company employee referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not provided. On an unspecified date in 2013 the patient was vaccinated with a dose of ZOSTAVAX and in 2015 was vaccinated with another dose, both for prophylaxis subcutaneous (dose and lot# were not provided for both vaccines). There were no known adverse effects. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
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 18-JUN-2015, the patient was vaccinated with GARDASIL 9 dose 1. On 21-JAN-2016, the patient was vaccinated with GARDASIL 9 dose 2 which was later than the recommended schedule. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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. On multiple unspecified dates, the patients were administered improperly stored (Oka/Merck) VARIVAX (lot # L048468, expiration date 02-DEC-2017, dose, route not provided). No adverse effects were reported. Names of vaccines involved: (Oka/Merck) VARIVAX. Lot number (s) and expiration date (s): L048468, expiration date 02-DEC-2017. Temperature: 0.2C. Time frame: 1 hour and 30 minutes. Was it administered (AE): Yes. Previous temperature excursion: No. Was call because of a "data logger": Yes. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients. There was no pertinent medical history, concurrent medication or drug allergies/drug reactions reported. On unspecified dates the patient were administered with improperly stored doses of ROTATEQ (lot # L008057, expiration date 01-DEC-2016, oral, dose and frequency unknown). The vaccines were exposed at 61 Fahrenheit (F) for 6 hours and back in range after that. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On 19-MAY-2016 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # K020215, expiration date 15-MAY-2016, dose, dose# and route unknown). No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history concomitant medications and drug reactions or allergies reported. On 19-MAY-2016, the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX (lot#, expiration date, dose, anatomical location and route of administration were not reported) instead of ZOSTAVAX due to nursing error. No adverse effect were reported. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 6 unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 28-APR-2016, one patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # L044475 (expiry date: 12-MAY-2017) (dosage not reported). The temperature excursion was -0.5 (unspecified units) for 7 days. No previous excursion was reported. No adverse effect reported. This is one of several reports 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 was received from a pharmacist refers to a 6 unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 29-APR-2016, one unspecified patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, lot # L048848 (expiry date: 19-AUG-2018) (dosage not reported). The temperature excursion was -0.5 (unspecified units) for 7 days. No previous excursion was reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 6 unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 02-MAY-2016, one unspecified patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, lot # L0048848 (expiry date: 19-AUG-2018) (dosage not reported). The temperature excursion was -0.5 (unspecified units) for 7 days. No previous excursion was reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MNQ
Symptoms: Back pain, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Fever 101.9, body aches and chills, lack of appetite, back pain/headaches, fatigue, light sensitive. Started right after vaccines and has lasted over 3 days.
Age: 16.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MNQ
Symptoms: Pain, Photophobia, Pyrexia
Clinical narrative: Fever 101.9, body aches and chills, lack of appetite, back pain/headaches, fatigue, light sensitive. Started right after vaccines and has lasted over 3 days.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a male patient of unknown age referring to himself. On an unknown date the patient transported a dose of ZOSTAVAX (unspecified lot number and expiration date) from an unspecified pharmacy to his unspecified doctor's office "without an ice pack". Then he was vaccinated with the improperly stored dose of ZOSTAVAX (dose and route unknown). No adverse effects were reported. Additional information is not expected because there was no contact details.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a clinical medical assistant referring to an unspecified number of patients of unknown age and gender. The patients'' pertinent medical history and drug reactions/allergies were not reported. Since 21-MAR-2016 the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L025738 with expiration date 14-AUG-2017, dose and route unknown). The temperature/time frame was 8.5 Celsius degree for 2.5 days (60 hours). No adverse effects were reported. This is one of several cases 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 pharmacist refers to a 6 unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 26-APR-2016, one unspecified patient was vaccinated with an improperly stored dose of VAQTA, lot # L049953 (expiry date: 14-JAN-2017) (dosage not reported). The temperature excursion was -0.5 (unspecified units) for 7 days. No previous excursion was reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
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. No relevant medical history or concurrent conditions were reported. On 19-MAY-2016, the patient was inadvertently vaccinated with an expired dose of RECOMBIVAX HB injection 10Y (lot # J007946, expiration date 24-MAR-2016; dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient - cellulitis at injection site treated with antibiotics.
Age: 0.4
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 5 months old patient of unknown gender. Patient's medical history, concurrent conditions and concomitant medication were not reported. In approximately April 2016 (reported as about a month ago), the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscular or subcutaneous (strength, dose and frequency not reported) (Inappropriate schedule of drug administration) instead of PREVNAR (wrong drug administered). The patient did not seek medical attention and no treatment was given. No lab studies were performed. At the time of this report, the patient's status was unknown, because the reporting physician did not hear anything. No further information provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of over the age of 65 years with unspecified cancer. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with a first dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported). On an unknown date, about one year after vaccination, the patient developed shingles. On an unknown date, about one year after developing shingles, the patient was vaccinated with a second dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported). The outcome of shingles was unknown. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Memory impairment, Presyncope
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 17 year old female patient. The patient's medical history included syncope. No concurrent conditions and drug reactions/allergies were reported. On 02-MAY-2016, the patient was administered with first dose of GARDASIL 9 (dose: 0.5 ml, once, lot # L038503, expiry date: 18-DEC-2017) via intramuscular route. No concomitant medications were reported. Healthcare worker reported that an unspecified time after receiving the vaccine, the patient experienced a near syncopal episode which lasted for about 10 seconds and then she returned back to normal. The patient required medical attention as the adverse event occurred in the physician's office. Healthcare worker also reported that the patient did not fully lose her consciousness, however, she did lose her memory for about 5 seconds and did not remember the episode occurring. No treatment was provided for the adverse events. Healthcare worker stated that they monitored the patient's vital signs for 15 minutes following the episode and all her vital signs were found to be normal. Outcome of the events were reported as recovered. Reporting healthcare worker had no assessed the causality of events with respect to therapy with GARDASIL 9. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a 58 year old female patient. Patient's medical history, concurrent conditions and concomitant medications were not reported. In approximately 2010, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dosing details not provided). Subsequently, on an unspecified date, the patient experienced an unspecified reaction at the injection site. The outcome of the event was unknown at the time of report. Causality assessment was not provided. No further information provided. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The nurse noted that on multiple unspecified dates, multiple unspecified patients were administered with improperly stored VARIVAX (lot # K007979 with expiration date 03-JUN-2016, lot # L021211 with expiration date 10-JUN-2017; dose and frequency not provided) (incorrect product storage). The vaccines were stored at 29 Fahrenheit (F) for 4 hours. The vaccines were previous stored at 39 F for 3 hours as well as 33 F for 3 hours. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. This nurse noted that on multiple unspecified dates, multiple unspecified patients were administered with improperly stored PROQUAD (Merck) (lot # L044058, expiration date 02-MAY-2017, dose and frequency not provided) (incorrect storage of drug). The vaccines was stored at 29 Fahrenheit (F) for 4 hours. There was no previous temperature excursion. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US019964 is an initial spontaneous report received from a nurse on 03 Oct 2014, and with a follow up report received from nurse on 11 Nov 2014. This report refers to a 12 years old female patient. Her medical history and concomitant medications were not reported. Concomitant vaccines included tetanus diphtheria acellular pertussis vaccine (other manufacturer, batch number: 4EK53) 0.5 ml IM; Varicella (other manufacturer, batch number: 5007727) 0.5 ml subcutaneous; human papilloma vaccine (other manufacturer, batch number: K006095) 0.5 ml IM and hepatitis A vaccine (other manufacturer, batch number: GX2LA) 0.5 ml IM on 02 Oct 2014. She was vaccinated with MENVEO (batch number: M13046) 0.5 ml intramuscularly, into right deltoid on 02 Oct 2014. It was reported that she received Men A lyophilized component reconstituted with sterile diluent instead of MenCYW-135 liquid component. She was advised to repeat vaccination with MENVEO. No adverse event was reported following the maladministration. Follow up report received from nurse on 11 Nov 2014. Updated patient details (height and weight), site of MENVEO and all concomitant vaccines.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 3 month old patient of unknown gender. The patient was planned to receive ROTATEQ on 30-APR-2016. On 30-APR-2016, patient came to office but vaccination was deferred as patient had fever. Nurse stated that, on 04-MAY-2016 the patient returned to office and received first dose of ROTATEQ (lot # L029618) at a dose of 2.0 ml, once orally which was beyond age guideline for first dose. No adverse effects have been reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 58 year old female patient, regarding herself. Concomitant medication was reported as "blood-pressure". Pertinent medical history and drug reactions/allergies were none. On 02-MAY-2016, the patient was vaccinated with ZOSTAVAX, 0.65 ml, (lot #, expiry date, route of administration were unspecified). On 04-MAY-2016 (two days after being administered vaccine), the patient developed a headache and was currently experiencing injection site reactions which included: redness, swelling and "heat" around the injection site. Lab diagnostics studies performed were none. Therapy with ZOSTAVAX was continued. The outcome of headache was recovered (dissipated) after taking TYLENOL. The outcome of injection site reactions was not recovered. Causality assessment was not provided. The patient did not seek medical attention. No product quality complaint (PQC) was involved. No further adverse event information was provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding an unspecified number of patients of unknown demographics. There was no pertinent medial history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On an unknown date the patient were vaccinated with improperly stored PEDVAXHIB lot no. L042836, expiration date 25-AUG-2018 (incorrect product storage). No adverse event was reported. It was exposed to temperature of -2 C (degree Celsius) for 410 hours. Previously it was not exposed to temperature excursion. The call was because of a data logger. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-MAY-2016 the patient was vaccinated with ROTATEQ (lot #L008054; expiry date: 30-NOV-2016), at an unspecified dose, orally that had been improperly stored (incorrect product storage). The vaccines were exposed to temperature of 58.8 F for 3.75 hours and the data logger was involved. No previous temperature excursion was reported. No adverse effect was 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 pharmacist refers to a 6 unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 26-APR-2016, one unspecified patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, lot # M006139 (expiry date: 13-MAY-2017) (dosage not reported). The temperature excursion was -0.5 (unspecified units) for 7 days. No previous excursion was reported. No adverse effect 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 certified medical assistant regarding an unspecified number of patients of unknown demographics. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On an unknown date the patient were vaccinated with improperly stored GARDASIL 9, lot # L048237, expiration date 08-MAY-2017 and lot # L018351, expiration date 11-AUG-2017 (incorrect product storage). No adverse event was reported. It was exposed to temperature of -2 C (degree Celsius) for 410 hours. Previously it was not exposed to temperature excursion. The call was because of a data logger. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding an unspecified number of patients of unknown demographics. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On an unknown date the patient were vaccinated with improperly stored ROTATEQ lot # L023866 expiration date 24-MAR-2017. No adverse event was reported. It was exposed to temperature of -2 C(degree Celsius) for 410 hours. Previously it was not exposed to temperature excursion. The call was because of a data logger. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender, possibly a newborn. The patient's medical history, past drug history, and concomitant medications were unknown. Approximately on 05-MAY-2016 (reported as on either 05-MAY-2016 or 06-MAY-2016), the patient was vaccinated with the first dose of RECOMBIVAX HB via injection (lot # L039660, expiry date 04-FEB-2018) (dose, route, anatomical location were not provided) which had previously undergone a supported temperature excursion. It was unknown if there was any relevant laboratory data. As of a time of this report, it was unknown if the patient had continued to take RECOMBIVAX HB and the outcome of receiving a vaccine that had undergone a temperature excursion was unknown. This is a one of the several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to a 4 year old male child. Patient's medical history and concurrent conditions were not provided. On 18-MAY-2016, the patient was vaccinated with an improperly stored doses of PROQUAD (Merck) (rHA, lot # M002055, expiry date 11-JUL-2017), and VARIVAX (Merck) (lot # L048463, expiry date 02-DEC-2017). Other co-suspect or concomitant medications were not reported. The vaccine was storage with a temperature of 21.3 degrees C, with a time frame of 18 hours. The report was no made because of a data logger. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
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. The patient's medical history was not reported. The reporter stated that on 16-MAY-2016, the patient was inadvertently administered an expired dose of PNEUMOVAX 23 lot number K020215, expiration date 15-MAY-2016 (dose, route and site of administration not reported). No adverse effects reported. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative and refers to a 16 month old female patient. No pertinent medical history, concurrent conditions or drug reactions/ allergies were reported. On 19-MAY-2016, the patient was inadvertently vaccinated with GARDASIL 9, in her thigh (the dose, dosage number, route of administration, lot # and expiration date were unknown). No concomitant medications were reported. Despite being vaccinated with GARDASIL 9 at such an age, no adverse effects were reported. The patient did seek medical attention. This vaccination occurred since the reporter did not know what medication was intended to be administered to the patient. Nevertheless, no product quality complaint was involved. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt received GARDASIL above recommended age 9-26 y/o. No adverse event.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received nurse refers to 39 unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX, (lot # L032396, expiry date: 26-AUG-2017 and lot # L045956, expiry date: 17-NOV-2017) (route, dose and frequency not reported). The vaccines were exposed to temperature of -14.41 degree Celsius for 9 hours 45 minutes. No previous temperature excursion was reported. The temperature excursions were detected by a data logger. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain
Clinical narrative: Vaccine was administered 5/19/16. Pt complained of redness at site and slight pain in upper back. She said pain may be due to past injury.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Somewhat itchy. Two inch wide red stripe extending approx. 6 inches up her arm per patient phone call. Advised her to notify her physician.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain
Clinical narrative: 1 inch blister surrounded by 4 inch redness throbbing during night. Suggested cold compress as tx.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: Parents described redness left thigh 1 day after vaccines infant had fever 103 degrees F. Parents concerned for lump left thigh at vaccine site (2.5 cm x 1.5 cm measured) on 5/18/16 at office for re-check.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site erythema, Injection site mass, Injection site swelling, Oedema peripheral
Clinical narrative: Reported swelling and redness at injection site described as a hard lump. Also redness and swelling of axillary area of left arm. Said to be soft when touched. Started 05/12/16. PCP said to give fever/pain reducer as needed and apply warm compress. Take to ER or urgent care if it worsens. Call 911 if any signs of symptoms of anaphylactic reaction occur. 5/18/16 Follow up call - Redness is gone and swelling is almost gone per mother.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Varicella post vaccine
Clinical narrative: Patient with mild case of what appears to be chickenpox after vaccine administration.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Licensed Practical Nurse refers to a patient of unknown age and gender. Information on patient's medical history and concurrent condition was not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ lot # L027726, expiry date 10-MAY-2017. It was reported that the temperature excursion call was because of usage of data logger. Temperature excursion was 32 F. Time frame: 15 hours. There was no previous excursion reported. No adverse effects reported. No further information was provided. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Irritability
Clinical narrative: Received vaccines (PENTACEL, PREVNAR 13 and Rotavirus) on Friday, May 13, 2016. Reported on May 18, 2016 the baby has been crying and fussy everyday since including day received. No other symptoms per parent.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Injection site swelling, Pruritus, Rash erythematous
Clinical narrative: Swelling noted below the injection site, then six (6) days later a burning/itching sensation was noted below injection site and found a bright pink rash - size of lid of Dannon yogurt. Treated 2xs/day with betamethasone DP 0.05% cream x 7 days (5/11), whereby rash gradually faded - resolved 5/15.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain (localized) left deltoid 3 day course of prednisolone 15mg/5mL = 10mL one daily.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site rash
Clinical narrative: 3 days after vaccines administered mom noticed rash on right thigh.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives began overnight 5/20 -> 5/21 and worsened over the course of 5/21. Also had fever up to 102.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history reported. On an unspecified date since 01-APR-2016, the patient was vaccinated with improperly stored doses of PROQUAD (Merck) lot number L040412, expiration date 13-APR-2017 and lot number L030587, expiration date 10-FEB-2017. Albumin status for lot number L040412 and L030587 was determined to be recombinant human albumin (rHA). The nurse could not specify the lot of PROQUAD (Merck) that the patient received and stated that it had to have been one of the other for this patient. The temperature excursion for PROQUAD (Merck) was 33.8 F for a timeframe of 6 hours and 45 minutes. After excursion, the temperature went back to range. Digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Rash erythematous, Skin warm
Clinical narrative: Warm erythematous patch 4 cm area, with redness and pain.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 18 hours post vaccination parent noticed small red area next to injection site (L thigh). Over the next 48 hr the redness on (L) thigh extended and measured 6.5 inches diameter in office today. She has redness, warmth, swelling and tenderness to palpation. No itching. Two injection sites noted on (L) thigh, approx. 1 inch apart. The signs above are medial to both injection sites. Vaccines were given by experienced MA. I Rx cephalexin and plan to see patient back in 2 days. Dx: cellulitis, vaccine reaction.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Approximately 18 hours post vaccination parent noticed small red area next to injection site (L thigh). Over the next 48 hr the redness on (L) thigh extended and measured 6.5 inches diameter in office today. She has redness, warmth, swelling and tenderness to palpation. No itching. Two injection sites noted on (L) thigh, approx. 1 inch apart. The signs above are medial to both injection sites. Vaccines were given by experienced MA. I Rx cephalexin and plan to see patient back in 2 days. Dx: cellulitis, vaccine reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician assistant and refers to two patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with ZOSTAVAX subcutaneously, (lot number, expiry date, dose and anatomical site of injection were not reported). Concomitant therapies were not provided. On an unknown date, after receiving the vaccination, the patients developed shingles. It was also reported that the patients visited the physician's office on an unknown date. No product quality complain (PQC) was involved. At the time of reporting, the outcome of herpes zoster was reported as recovering. The reporter did not provide a causality assessment between the event and the ZOSTAVAX. Additional information is not expected, since the reporter did not consent further contact for follow-up.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Body temperature increased, Headache, Local swelling, Malaise
Clinical narrative: Localized swelling 2 inches plus; Low grade temperature 99.8; Joint pain; Malaise; Headache; Patient reports symptoms 5/17-5/21; TYLENOL.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: 3 days post injection redness and blisters at injection site with tenderness at site. No treatment administered at this time. Pt to return to office on 5/25/16 for reevaluation.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site macule, Injection site warmth
Clinical narrative: Case number PHHY2014US093767 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516286) web site on 24 Jul 2014. This case refers to an 11-year-old male child. His medical history and concomitant medications were not reported. On 03 Dec 2013, he was vaccinated with MENVEO (batch number: X12129) along with BOOSTRIX (other manufacture, batch number: 33AG5) intramuscularly in the left arm and GARDASIL (other manufacture, batch number: J008423) intramuscularly in the right arm. Following the vaccinations, on 04 Dec 2013, he experienced macular erythema that was warm to touch around the site where vaccines were administered and erythema was "12" on diameter. It was reported that no treatment was required. The final outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 11.0
Sex: M
Vaccine: HPVX, MNQ, TDAP
Symptoms: Blister, Injection site atrophy, Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2014US028246, is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number:518407) website on 06 Mar 2014. This report refers to a 01-year-old male infant. He was vaccinated with MENVEO (batch number: not reported) and Tdap vaccine (batch number: not reported) in the left arm and HPV vaccine (batch number: not reported) in the right arm on 31 Dec 2013. On the same date, in the evening his left bicep was swollen and red around the injection site. By the next day morning, it was even larger and he had fluid building under his armpit and it continued to worsen throughout the day and by the evening the red portion covered all of his bicep and below and the swelling underneath the arm felt like a fluid filled balloon and almost made his armpit indistinguishable. He was given ibuprofen and icing regularly. The patient was taken to the health department on 02 Jan 2014 and on the same date his injection site looked sunken. The physician stated that this was normal and occurs 50% of the time with Tdap and that it was often bad in teens and adults. On 04 Jan 2014, the swelling has gone down a lot, but it was not entirely gone. The final outcome of the events reported as recovered.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Anxiety, Crying, Depression, School refusal
Clinical narrative: Case number PHHY2014US042890 is an initial spontaneous report received from a consumer (patient's mother) via Vaccine Adverse Event Reporting System (VAERS reference number: 518656) web site on 08 Apr 2014. This report refers to an 11-year-old male child. The child had a medical history of asthma, obesity, allergic rhinitis and atopic dermatitis. His concomitant medications included PROAIR HFA, DIMETAPP, FLOVENT, FLONASE and triamcinolone. On 29 Jan 2013, the child was vaccinated with meningococcal vaccine (manufacturer and batch number: not reported, hence conservatively coded as MENVEO INN) and GARDASIL (other manufacturer, batch number: H010649) in the right arm along with TDAP (manufacturer and batch number: not reported). Following the vaccinations, on 14 Feb 2013, the child was crying, refused to go to school and experienced anxiety that lasted for several weeks. On 19 Feb 2013, the child was taken to the emergency room. On 02 Apr 2013 and 31 Jul 2013, the child was again vaccinated with two doses of GARDASIL, and days after vaccination, he experienced the same events (crying, school refusal and anxiety). The child was referred to a behavioral health specialist and was diagnosed with anxiety and depressive disorder. The final outcome was reported as completely recovered. The events were assessed as non serious and no information about causality was provided.