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 a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 25-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) with lot number: L007230, expiry date: 03-SEP-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports 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 a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-SEP-2015, the patient was vaccinated with improperly stored (Oka-Merck) PROQUAD with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom stated patient was with dad day of vaccines given, when she picked her up the following day is when she noticed the redness and swelling on (R) right thigh. Next day got a little bigger.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster reaction 2 days post exposure to vaccine on same arm as vaccine afebrile treated with valcyclovir, vaccine given 1/29/16.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and concerns a patient of unknown age and gender. The patient's medical history and concurrent conditions were unknown. It was reported that since on an unknown date, an improperly stored dose of with RECOMBIVAX HB (lot # L026598, expiry date 26-JUN-2017 (dose and route were not reported) was given to the patient on 04-FEB-2016. It was reported that the vaccine was at 27 Fahrenheit of temperature and its time frame was 35.5 hours/360 hours , there was not previous excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 23-SEP-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K010215, expiry date: 05-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-NOV-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K011562, expiry date: 08-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition medical history or allergy/drug reactions were reported. On 21-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K011562, expiry date: 08-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L006390, expiry date 25-AUG-2016, albumin status HSA and lot # L040414, expiry date 13-APR-2017, albumin status rHA; dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion (14.7F for 2 hours and 15 minutes). There were no previous temperature excursions. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-NOV-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K011562, expiry date: 08-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K010215, expiry date: 05-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports 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 a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 07-OCT-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 04-FEB-2016, the patient was vaccinated with an expired dose of ZOSTAVAX, lot # K020802, expiration date 31-JAN-2016, subcutaneous (dose was not reported). No known adverse effects or PQC involved. There was no concomitant medication provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient concurrent conditions and medical history were not provided. On 28-DEC-2015, the patient was vaccinated with the first dose of VAQTA, intramuscular (dose, lot # and expiration date were not reported, then on 28-JAN-2016, the patient was vaccinated with the second dose of VAQTA, intramuscular, lot # L036449, expiration date 26-MAY-2017 (dose was not reported). No adverse effect nor product quality complaint were reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Myositis
Clinical narrative: 1 day following immunization, noticed considerable swelling, redness, pain on upper left arm. Entire muscle was inflamed. Felt nausea. Symptoms completely resolved effective Monday, 02/08/16.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: 1 day following immunization, noticed considerable swelling, redness, pain on upper left arm. Entire muscle was inflamed. Felt nausea. Symptoms completely resolved effective Monday, 02/08/16.
Sex: M
Vaccine: HPV9
Symptoms: Asthma, Condition aggravated, Immediate post-injection reaction, Panic attack
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative regarding a male patient of unknown age with asthma. The patient's medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9, intramuscular, (dose, anatomical location, lot number and expiration date were not reported, it was unknown if the vaccination was the first, second or the third in a series of three injections for the patient. There was no concomitant medication reported. On an unknown date, the patient experienced a panic attack which resulted into an asthma attack immediately after received the dose of GARDASIL 9. The patient sought medical attention in the office and none laboratory diagnostic studies were performed. Unspecified steroid injection was given to the patient as treatment. At the time of the report, the outcome of the panic attack which resulted into an asthma attack was unknown. The relatedness between the events and therapy with GARDASIL 9 was not reported. Additional information is not expected because there was no consent for follow up.
Sex: U
Vaccine: HPV4
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. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-SEP-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K010215, expiry date: 05-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K011562, expiry date: 08-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Asthma, Rubber sensitivity, Seasonal allergy
Clinical narrative: This spontaneous report received from a nurse refers to a 22 years old female patient. No pertinent medical history was reported. The patient drug reaction/allergies included amoxicillin allergy and penicillin allergy. On 27-AUG-1997 the patient was vaccinated with one dose of VARIVAX (Merck) (dose route and frequency: unknown). On an unspecified time after receiving VARIVAX (Merck), the patient experienced an anaphylactic reaction due to coming into contact (in an unspecified way) with a latex glove; which lead to the patient being diagnosed with a "severe" latex allergy. The nurse also reported that the patient has developed "worsening" asthma and seasonal allergies "over the years" but the nurse did not know when the patient was diagnosed with asthma or seasonal allergies so unknown if the asthma and seasonal allergies developed prior to the patient receiving VARIVAX (Merck) or after. Other suspect therapies included hib conj vaccine (unspecified carrier), diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid (diphtheria toxoid (+) hib conj vaccine (unspecified carrier) (+) pertu; unspecified manufacturer; dose route and frequency: unknown) (first dose on 10-SEP-1993, second dose on 03-DEC-1993, and third dose on 27-MAY-1997). It was also reported that, on an unspecified date after the third dose of hib conj vaccine (unspecified carrier), diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid (diphtheria toxoid) (+) hib conj vaccine (unspecified carrier) (+) pertu, the patient had an unspecified reaction. No other concomitant therapy was reported. The action taken is not applicable. The patient had seek medical attention. No significant disability or incapacity was reported. The events were not life threatening and no hospitalization was reported. The outcome of the reported adverse events are unknown. The causality of the adverse events are not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-DEC-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K011562, expiry date: 08-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to 3 unspecified patients of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On unspecified dates, these patient were vaccinated with an improperly stored dose (Oka/Merck) VARIVAX (from either lot # K008819, expiry date: 19-JUN-2016 or lot # L011085, expiry date: 01-APR-2017). Reporting nurse stated that the mentioned vaccine was out of range for a total time frame of 198 hours and maximum temperature reached was 0 degree Celsius. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
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. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-JUL-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 29-JUL-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 03-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 31-JUL-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-JUL-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 24-JUL-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 01-FEB-2016, the patient was vaccinated with an expired doses of PNEUMOVAX 23 (lot # K009107, expiration dates: 21-JAN-2016) (does and route were not provided). Concomitant medication was not reported. No adverse effect was reported and there was not product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The concurrent conditions and medical history were not provided. On 29-JAN-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX, (route and dose were not provided) Lot#: L037797, expiration date on 30-DEC-2016. Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. Additional information is not expected, since no permission for further contact was given.
Sex: U
Vaccine: HPV4
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. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-OCT-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-OCT-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-OCT-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 07-OCT-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-OCT-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-OCT-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 26-OCT-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
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. No concurrent condition, medical history or allergy/drug reactions were reported. On 07-OCT-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date:10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information as been requested.
Sex: U
Vaccine: MMRV
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. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-AUG=2015, the patient was vaccinated with improperly stored PROQUAD (Merck) with lot number: L007230, expiry date:03-SEP-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-OCT-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date:10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender,. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-NOV-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L028276, expiry date 28-JUL-2017, lot # L009205, expiry date 17-MAR-2017, lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Oka/Merck) VARIVAX underwent temperature excursions (14.7F for 2 hours and 15 minutes). There were no previous temperature excursions. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-NOV-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL ith lot number: K016966, expiry date: 10-MAY-2-017 (dose and strength unspecified). No concomitant medications were reported. No adverse effect were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHHY2014US051431 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 523764) on 24 APR 2014: This report refers to a 15-year-old female patient. Medical history was not reported. Her concomitant medications included Claritin. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) along with third dose of GARDASIL (batch number: J012212 and expiry date: 18 FEB 2014) intramuscularly on 18 FEB 2014. She became pregnant with LMP of 17 DEC 2013 and EDD of 23 SEP 2014. Initial exposure to the vaccines was at nine weeks. The pregnancy outcome was outcome pending. No adverse effects reported. The patient underwent unspecified pregnancy test and unspecified flu and strep screening test. Results for any of these tests were not reported. Outcome of the event was reported as unknown. Seriousness was assessed as non-serious by the reporter. No further information about causality was reported. Follow up information received on 08 DEC 2014: This case is lost to follow up because the reporter was anonymous.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Influenza like illness, Pain, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2044US159732 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 543730) website on 28 NOV 2014. This report refers to an 81 years old male patient. His medical history was not reported. His concomitant medications included naproxen sodium, simvastatin and omeprazole. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and pneumococcal vaccine (other manufacturer, batch number: not reported); both vaccines administered on 12 SEP 2014. On 12 SEP 2014, he experienced painful sore left upper arm musculature extending below vaccination site into bicep followed by redness and swelling. The  next day he experienced flu like achiness across back and upper body. He had fever in the night of 13 SEP 2014. On 14 SEP 2014, fever and achiness went, but swelling and soreness in the biceps remained at the date of reporting with skin redness in the same area which  was slowly diminishing. The final outcome of fever and aching was reported as complete recovery on 14 SEP 2014. The outcome of redness was reported as condition improving and that of painful sore upper arm and swelling was reported as  condition unchanged. The events were reported as non-serious. The causality of the events were not reported.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Swelling
Clinical narrative: Case number PHHY2044US159732 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 543730) website on 28 NOV 2014. This report refers to an 81 years old male patient. His medical history was not reported. His concomitant medications included naproxen sodium, simvastatin and omeprazole. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and pneumococcal vaccine (other manufacturer, batch number: not reported); both vaccines administered on 12 SEP 2014. On 12 SEP 2014, he experienced painful sore left upper arm musculature extending below vaccination site into bicep followed by redness and swelling. The  next day he experienced flu like achiness across back and upper body. He had fever in the night of 13 SEP 2014. On 14 SEP 2014, fever and achiness went, but swelling and soreness in the biceps remained at the date of reporting with skin redness in the same area which  was slowly diminishing. The final outcome of fever and aching was reported as complete recovery on 14 SEP 2014. The outcome of redness was reported as condition improving and that of painful sore upper arm and swelling was reported as  condition unchanged. The events were reported as non-serious. The causality of the events were not reported.
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Case number PHHY2014US159338 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 543803) website on 28 Nov 2014. This report refers to a 73 years old male patient. His current condition included chronic obstructive pulmonary disorder (COPD) and concomitant medications were PRO-AIR inhaler, Baby aspirin and multivitamin. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the upper left shoulder on 08 Sep 2014. On the same day after vaccination, he experienced extreme muscle weakness at the site of vaccination on the upper left shoulder. He went to emergency room. The muscle pain at the site lasted over a week and was not totally subsided. His left arm almost immobile, but gradually improved. The final outcome of the muscle pain at site was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Pain in extremity, Rash erythematous
Clinical narrative: Case number PHHY2014US159347 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 543952) website on 28 Nov 2014. This report refers to a 73 years old female patient. Her medical history was not reported and concomitant medications included triamterene. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the triceps on 12 Sep 2014. On the same day after vaccination, she experienced pain in arm from elbow to shoulder. Her site at arm was swollen, and she had a red rash on tricep. The final outcome of muscle pain at site was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2015US159843, is an initial spontaneous report received from a nurse (patient) via the Vaccine Adverse Event Reporting System (VAERS, reference number: 544020) website on 28 Nov 2014. This report refers to a 49 year old female patient. Medical history was not reported. Concurrent conditions included asthma, hypertension and GERD. Concomitant medications included PROTONIX and lisinopril. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in left arm on 15 Sep 2014. On 17 Sep 2014, she developed diarrhea, vomiting and fever at a body temperature of 100.1 degree Fahrenheit. It was reported that the patient was around sick people all the time. The outcome of the events was not reported. These events were reported as non-serious. The nurse reported that the events were not related to vaccination with seasonal influenza vaccine.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Rash, Urticaria papular
Clinical narrative: Case number PHHY2015US156164 is an initial spontaneous report received the Vaccine Adverse Event Reporting System (VAERS reference number: 544162) website on 28 Nov 2014. This report refers to a 46 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscular in the left arm on 17 Sep 2014. On 17 Sep 2014, after vaccination, rash appeared a few hour later and worsened overnight. He had popular hives and rash on torso spreading down to his arms, legs and trunk. The outcome was reported as condition unchanged. The seriousness of the events was not reported. The causality of the events was not reported.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Asthenia, Dizziness, Fatigue, Impaired driving ability
Clinical narrative: Case number PHHY2014US159679, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544248) website on 28 Nov 2014. This report refers to a 58-year-old male patient. Historical conditions were not reported. This polymedicated patient received seasonal influenza vaccine (manufacturer and batch number: not reported) on 17 Sep 2014. On 18 Sep 2014, the patient experienced dizziness, weakness and fatigue. He was sick and could not drive. He called off his work. He had to make an effort to brush teeth. The outcome of the events was complete recovery. The events were reported as non-serious; Causality was not reported.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Impaired work ability, Malaise
Clinical narrative: Case number PHHY2014US159679, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544248) website on 28 Nov 2014. This report refers to a 58-year-old male patient. Historical conditions were not reported. This polymedicated patient received seasonal influenza vaccine (manufacturer and batch number: not reported) on 17 Sep 2014. On 18 Sep 2014, the patient experienced dizziness, weakness and fatigue. He was sick and could not drive. He called off his work. He had to make an effort to brush teeth. The outcome of the events was complete recovery. The events were reported as non-serious; Causality was not reported.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2014US159725, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544357) website on 28 Nov 2014. This report refers to a 54-year-old female patient. Historical conditions and current illness were none. Concomitant medication was none. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the upper left arm on 30 Oct 2013. On the same day after vaccination, the patient experienced pain at site of injection in upper left arm. The final outcome of the event was not recovered. The event was reported as non-serious; Causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: Case number PHHY2014US159590, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544525) website on 28 Nov 2014. This report refers to a 47-year-old female patient. Concomitant drugs included PROZAC, ADDERALL, TOPOMAX and JOLESSA. She was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) on 17 Sep 2014. On 18 Sep 2014, she experienced severe joint pain, nausea, chills, fatigue and sweats lasting 48 hours. The symptoms eased slightly with ibuprofen. The final outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported.
Age: 30.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Case number PHHY2014US163282 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS ID: 544553) website on 28 Nov 2014. This report refers to a 30 year old female patient. Her past medical history was not reported. Her concomitant medications were not reported. She was treated with ibuprofen (batch number: not reported) at an unspecified dose, Benadryl (other manufacturer, batch number: not reported), DOC-Q-LACE (other manufacturer, batch number: not reported), PERCOCET (other manufacturer, batch number: not reported) and TYLENOL (other manufacturer, batch number: not reported) from 15 Sep 2014 by the medical center during stay. On 17 Sep 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported), with Tdap (other manufacturer, batch number: not reported) and with pneumococcal vaccine (other manufacturer and batch number: not reported). On 18 Sep 2014, treatment with ibuprofen, BENADRYL, DOC-Q-LACE, PERCOCET and TYLENOL was discontinued. On 19 Sep 2014, she developed chills, low grade fever, aches/pains and the area of injection was red, swollen and tender. On 20 Sep 2014, she was treated with cephalexin oral capsules at a dose of 500 mg. The outcome of the events was not reported. The events were reported as non serious and causality of the events was not reported.
Age: 30.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2014US163282 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS ID: 544553) website on 28 Nov 2014. This report refers to a 30 year old female patient. Her past medical history was not reported. Her concomitant medications were not reported. She was treated with ibuprofen (batch number: not reported) at an unspecified dose, Benadryl (other manufacturer, batch number: not reported), DOC-Q-LACE (other manufacturer, batch number: not reported), PERCOCET (other manufacturer, batch number: not reported) and TYLENOL (other manufacturer, batch number: not reported) from 15 Sep 2014 by the medical center during stay. On 17 Sep 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported), with Tdap (other manufacturer, batch number: not reported) and with pneumococcal vaccine (other manufacturer and batch number: not reported). On 18 Sep 2014, treatment with ibuprofen, BENADRYL, DOC-Q-LACE, PERCOCET and TYLENOL was discontinued. On 19 Sep 2014, she developed chills, low grade fever, aches/pains and the area of injection was red, swollen and tender. On 20 Sep 2014, she was treated with cephalexin oral capsules at a dose of 500 mg. The outcome of the events was not reported. The events were reported as non serious and causality of the events was not reported.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Case number PHHY2014US171421 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 544685) website on 29 Dec 2014. This report refers to an 83 year old male patient. His past medical history was not reported. His concomitant medications included metoprolol extended release at a dose of 25 mg and latanoprost 0.005%. On 15 Aug 2014, he was vaccinated with AGRIFLU (batch number: 1411201) intramuscularly into his left arm. On 16 Aug 2014, he had a large bruise, about three inches in diameter on his arm where he received the injection. The patient did not complain of any pain and did not receive any treatment. The patient was advised that if the bruise got any larger or spread, he should contact his physician. The patient completely recovered from the bruise after about 2 weeks. The event was reported as non serious and causality of the event was not reported.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: Case number PHHY2014US159392, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544849) website on 28 Nov 2014. This report refers to a 66-year-old female patient. Medical history was not reported. Concomitant medication included simvastatin. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 22 Sep 2014. On the same day, after vaccination, the patient experienced sore arm, fever and rash. Outcome of the events was reported as recovered. The events were reported as non-serious. Causality of the events was not reported.