chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician as part of a marketing research program conducted by agency refers to a 65 year old female patient. Patient's medical history and concurrent conditions were not reported. In approximately August 2013, reported as two years ago, after the patient was vaccinated with ZOSTAVAX (dose, route, frequency and lot No. were not informed) for prevention of shingles but she developed shingles about 1-2 weeks later, approximately in August 2013. Concomitant medications were not described. At the time of this report, the outcome of the event mentioned above was recovered (also reported as not recovered-conflicting information). The reporter physician considered the event to be related to ZOSTAVAX. Additional information is not expected as reporter did not provide consent for follow up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Thiss spontaneous report was received from a Registered Nurse, referring to an unspecified number of patient's of unknown demographics. No medical history nor concurrent conditions were reported. On unknown dates, unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # K021487, expiration date 03-NOV-2016; lot # 026387, expiration date 15-DEC-2016; lot # L001335, expiration date 13-JAN-2017; lot # L002217, expiration date 21-JAN-2017; lot # K008819, expiration date 19-JUN-2016; lot # K007979, expiration date 03-JUN-2016 and lot # K005428, expiration date 15-APR-2016) (strength, dose and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaints were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown in 2015, the patient was vaccinated with an expired dose of MMR II (lot # J010208 exp date 23-FEB-2015 also reported as 23-AUG-2015) (dose and route not reported). No adverse experiences were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 03-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454 expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 17-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose and frequency were not reported) lot # L008355, expiration date 11-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 14-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (strength, dose and frequency were not reported) lot # L015046, expiration date 29-APR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 17-AUG-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (strength, dose and frequency were not reported) lot # L015046, expiration date 29-APR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 20-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose and frequency were not reported) lot # L008355, expiration date 11-SEP-2016. No adverse effects were reported. This is one of several reprots received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 19-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose and frequency were not reported) lot # L008355, expiration date 11-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 18-AUG-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (strength, dose and frequency were not reported) lot # L015046, expiration date 29-APR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 17-AUG-2015, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (strength, dose and frequency were not reported) lot # K023623, expiration date 20-FEB-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 01-JUL-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot # L000454, expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of flu symptoms in a 38-year-old female patient who received FLUARIAX QUADRIVALENT (batch number 23J79, expiry date June 2016). Previously administered products included unspecified vaccine (no serious reactions to previous vaccines). Concomitant products included cyclobenzaprine and Z pack. On the 18th August 2015, the patient received the 1st dose of FLUARIX QUADRIVALENT .5 ml. On 19th August 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced flu symptoms. On an unknown date, the outcome of the flu symptoms was not recovered/not resolved. The reporter considered the flu symptoms to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: On 18th August 2015, at 20.30 pm, the patient received the 1st dose of FLUARIX QUADRIVALENT. The reported batch number 23579, dose not exist but according to the sales data the correct batch number should be 23J79. This case was not previously reported to anyone.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 02-JUL-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot # L000454 expiry date: 06-JAN-2017 (route and dose were not provided). 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: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The nurse reported that on an unspecified dates, the patient received two doses of GARDASIL (route, dosage, lot # and expiration date were not reported), and afterwards on 17-AUG-2015, the patient was vaccinated with GARDASIL 9 (route, dosage, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unkonwn age and gnder. The patients' concurrent conditions, past medical history and concomitant therapies were not reported. On unknown dates in 2015 (reported as: since 03-JUN-2015) the patients were vaccinated with improperly stored GARDASIL (lot # K023432 exp. date 18-JUN-2016) (dose, frequency and route were not provided). No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients might have vaccinated with second dose of GARDASIL 9 a month after receiving their first dose of GARDASIL 9 which is outside of the recommendations in the GARDASIL 9 prescribed information. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HEP, HIBV, PNC13
Symptoms: Diarrhoea, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Cellulitis-left arm swelling c/o pain since shots 8/24. Area of redness/warmth since 8/25. Hives to chest and back 8/25 pm. Vomited x 1 on 8/25. Diarrhea x1 on 8/26.
Age: 3.0
Sex: M
Vaccine: HEP, HIBV, PNC13
Symptoms: Injection site warmth, Urticaria, Vomiting
Clinical narrative: Cellulitis-left arm swelling c/o pain since shots 8/24. Area of redness/warmth since 8/25. Hives to chest and back 8/25 pm. Vomited x 1 on 8/25. Diarrhea x1 on 8/26.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray, Echocardiogram abnormal, Fatigue, Pain in extremity, Painful respiration
Clinical narrative: Fever, fatigue, sore arm, rawness in her chest with deep breathing.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fever, fatigue, sore arm, rawness in her chest with deep breathing.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Incorrect dose administered, Underdose
Clinical narrative: This spontaneous report as received from a health professional refers to a female patient of unknown age. Informatino about the patient's medical history and concurrent conditions was not provided. On an unknown date, when the patient was a baby, she was vaccinated with a dose of RECOMBIVAX HB, (administration route and expiration date were not provided). No concomitant therapies were reported. The reporter stated that the patient's titers were negative (hepatitis B surface antibody negative) on an unknown date. On an unknown date in July 2015, the patient was inadvertently administered a pediatric dose (incorrect dose administered/underdose) of RECOMBIVAX HB lot # L001626, (administration route and expiration date were not provided). Following the vaccination the patients titers were still negative (hepatitis B surface antibody negative). According to the reporter the patient saw the physician for this events. The outcome of hepatitis B surface antibody negative and underdose was reported as recovered. The reporter did not provide a causality relationship assessment between the events and therapy with RECOMBIVAX HB. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Swollen tongue
Clinical narrative: This spontaneous report as received from a physician, via a company representative, refers to a female patient of unknown age. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (Administration route, lot number and expiration date were not reported). Concomitant therapies included an unspecified Hepatitis A virus vaccine. According to the reporter, after having been vaccinated, the patient's tongue got swollen (swollen tongue), and her physician said it seemed "like an anaphylaxis reaction" (anaphylactic reaction). The outcome of swollen tongue and anaphylactic reaction was unknown at the time of this report. The reporter did not provide a causality relationship assessment between the events and therapy with GARDASIL. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 03-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454 expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 17-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose and frequency were not reported) lot # L008355, expiration date 11-SEP-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 13-JUL-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot # L000454, expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered medical assistant referring to an unspecified number of patients of unknown age and gender. On an unknown date in 2015, the patients were vaccinated with improperly stored M-M-R II (dose, strength and route were not reported, lot# K021152). The temperature was possible out of range by 2 degrees to 3 degrees for short periods of time over a couple of days in April 2015. No adverse events were reported. This case is one of several cases received from the same source. Additional information has been requested. This case was initially received on 28-MAY-2015 and reported in 1506USA000575. 1506USA000575 has been deleted upon the follow up information received on 01-JUL-2015, in which the medical assistant stated no incorrect product storage happened. Now, case was re-created due to new follow up information was received from the medical assistant on 13-AUG-2015 and incorrect product storage was confirmed.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia, Vaccination failure
Clinical narrative: Information has been received from a pharmacist via field representative referring to an 86 year old female patient. Patients medical history, concurrent conditions and drug reactions/allergies were not reported. On 15-AUG-2015, the patient was vaccinated with PNEUMOVAX23 (strength, dose, frequency, route, lot #, expiry date unspecified). No concomitant medications were reported. Reporting physician stated that the patient developed pneumonia on an unspecified date in 2015, after she receiving the PNEUMOVAX23 (vaccination failure). Patient sought medical attention and called the pharmacist on an unknown date. Outcome of the events were unknown. Reporting pharmacist did not assessed the causality of the events with respect to vaccination with PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 13-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (strength, dose and frequency were not reported) lot # L007224, expiration date 03-MAR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (dose and route were not reported, lot # K015970 with expiration date 23-SEP-2016 or lot # K021847 with expiration date 13-JAN-2017) which were exposed to temperatures outside of the recommended range. There was no adverse event reported. 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 registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 21-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose and frequency were not reported) lot # reported as L019994, expiration date 02-DEC-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 14-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (strength, dose and frequency were not reported) lot # L007224, expiration date 03-MAR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 17-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose and frequency were not reported) lot # reported as L019994, expiration date 02-DEC-2016. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with the improperly stored dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a health care professional via a company representative refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with GARDASIL (dose, strength, route, lot # unspecified). Information about concurrent conditions, concomitant medication and medical history was not provided. On an unspecified date the patient received GARDASIL and had an adverse event that was not specified. The specific dose within the series of the GARDASIL that was administered to the patient was not specified. The representative did not have the necessary information. No further event information was provided. Additional information is not expected. Consent to follow up was not provided.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a nurse refers to an 18 year old male patient. The patient's concurrent conditions included vitamin D deficiency and Depression. On 07-NOV-2014 the patient had titers drawn which revealed negativity for immunity against measles. There was no documented evidence of receiving M-M-R II, subcutaneously (Lot number J006136, expiry date 24-APR-2015) (dosing regimen and frequency unknown). Concomitant therapies included vitamin D (unspecified) (Manufacturer unknown) and LEXAPRO. On 29-JUL-2015, the patient had repeat titers drawn which also resulted in negative immunity against measles (antibody test negative). There was no lab diagnostic studies performed. There was no treatment provided for the event. The action taken with the therapy with M-M-R II was unknown. The outcome of antibody test negative was reported as not recovered. The relatedness of the events to the therapy with M-M-R II was unknown. There was no product quality issue 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 medical assistant and refers to an unspecified amount of patients of unknown age and genders. No medical history, concurrent conditions or concomitant therapies were reported. On an unknown dates (since July 2014 till at least the end of January 2015), the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot #, expiration date, dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified amount of patients of unknown age and genders. No medical history, concurrent conditions or concomitant therapies were reported. On an unknown dates (since July 2014 till at least the end of January 2015), the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot #, expiration date, dose and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 24-JUL-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L000454 with exp. 06-JAN-2017, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified amount of patients of unknown age and genders. No medical history, concurrent conditions or concomitant therapies were reported. On an unknown dates (since July 2015 till at least the end of January 2015), the patients were vaccinated with improperly stored doses of adult and pediatric, VAQTA (lot #, expiration date, dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified amount of patients of unknown age and genders. No medical history, concurrent conditions or concomitant therapies were reported. On an unknown dates (since July 2014 till at least the end of January 2015), the patients were vaccinated with improperly stored doses of GARDASIL (lot #, expiration date, dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified amount of patients of unknown age and genders. No medical history, concurrent conditions or concomitant therapies were reported. On an unknown dates (since July 2014 till at least the end of January 2015), the patients were vaccinated with improperly stored doses of adult and pediatric RECOMBIVAX HB (lot #, expiration date, dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 03-JUL-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L000454 with exp. 06-JAN-2017, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 13-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L00454 expiry date: 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Feeling abnormal, Herpes zoster oticus, Ophthalmic herpes zoster
Clinical narrative: Information has been received from a 79 year old female patient with diabetes referring to herself. The patient had no drug reaction/allergies. In June 2014 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, single injection, subcutaneous, lot# and expired date were unknown) for prevention of shingles. Concomitant therapies included TOPROL XL TABLETS and LOTEMAX. Approximately 6 weeks ago, on 03-JUL-2015, the patient developed shingles in her eye. The shingles made her eye first "feel like it had broken glass in her eye". About 5 weeks ago, on 10-JUN-2015, she developed shingles in her ear. The shingles in her ear made it "feel like she was underwater". The patient sought medical attention by office visit. No lab tests were performed. ZIRGAN was given for the events as treatment. At the time of reporting, the patient's eye just burned. The patient did not recover from the events. Additional information is not expected since the reporter refused to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 22-AUG-2015, the patients was inadvertently vaccinated with an expired dose of PNEUMOVAX23 (Lot # K004542 exp date 19-AUG-2015) (dose and route not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an adult patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with a dose of PROQUAD (Merck) (lot#, expiration date, dose, frequency and route were unknown) (Inappropriate schedule of vaccine administered). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with GARDASIL (dose, route not reported, lot# K023432 with expiration date 18-JUN-2016) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 year old patient (unspecified gender). On 15-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. This is a corrected report. The AE term of "medication error" was changed to "incorrect product storage" which is more specific.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with COMVAX (dose, route not reported, lot# reported as J002621 with expiration date 29-NOV-2015) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 20-AUG-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L006386, expiration date 25-FEB-2017, 0.5 ml, subcutaneous). No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via a field representative referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (one time injection, dose and lot number not provided). On an unknown date, the patient was diagnosed with shingles after receiving the ZOSTAVAX vaccine. The outcome of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were not reported. On multiple unspecified dates, multiple unspecified patients were administered improperly stored VARIVAX (Merck) (Lotn umber L011083, expiration date 01-APR-2017, dose, frequency and route were unknown). The patient's concomitant medication was not reported. No adverse effect reported. There was no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Atelectasis, Chest X-ray abnormal, Computerised tomogram abdomen normal, Computerised tomogram normal, Computerised tomogram pelvis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. It was reported that a 64 year old male with allergy to morphine, allergic rhinitis, asthma, hypertension and a history of tubular adenoma was vaccinated intramuscularly with first dose of ZOSTAVAX (Merck) (site of injection not reported, lot number reported as 80683, not valid) on 02-NOV-2007. Concomitant therapy included ADVAIR, SPIRIVA, aspirin, folic acid and multivitamin. It was reported that the Herpes Zoster onset date was 29-SEP-2008 and was diagnosed on 03-OCT-2008 with V1 distribution. The disseminated Zoster was diagnosed on 06-OCT-2008, requiring hospitalization for IV acyclovir from 06-OCT-2008 to 09-OCT-2008 at Hospital. The patient recovered. On 20-OCT-2008, the medical record were received (06-OCT-2008 to 09-OCT-2008), the discharge diagnosis was disseminated Zoster. The patient had a history of asthma, hypertension and a history of tubular adenoma. It was noted that the patient presented with shingles rash already diagnosed for antiviral treatment. The patient had an itchy rash on left side of his face and scalp as well as multiple small eruptions on trunk and right arm. The patient had mild headache for last week. Ophthalmologist ruled out ophthalmic involvement. The patient was treated with acyclovir. Lab tests performed included chest X-ray (positive for mild atelectasis, otherwise within normal limits) and CT scan of the abdomen and pelvis (unremarkable). Labs unremarkable. The listing indicated that one or more of the events required hospitalization. No further information is available. The original reporting source was not provided. The VAERS ID number is 328424. 27-Aug-2015: this is a corrected report. The narrative was changed to reflect correct date of vaccination, 02-NOV-2007, and correct date of hospital discharge, 09-Oct-2008.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster disseminated, Laboratory test normal, Rash, Rash pruritic
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. It was reported that a 64 year old male with allergy to morphine, allergic rhinitis, asthma, hypertension and a history of tubular adenoma was vaccinated intramuscularly with first dose of ZOSTAVAX (Merck) (site of injection not reported, lot number reported as 80683, not valid) on 02-NOV-2007. Concomitant therapy included ADVAIR, SPIRIVA, aspirin, folic acid and multivitamin. It was reported that the Herpes Zoster onset date was 29-SEP-2008 and was diagnosed on 03-OCT-2008 with V1 distribution. The disseminated Zoster was diagnosed on 06-OCT-2008, requiring hospitalization for IV acyclovir from 06-OCT-2008 to 09-OCT-2008 at Hospital. The patient recovered. On 20-OCT-2008, the medical record were received (06-OCT-2008 to 09-OCT-2008), the discharge diagnosis was disseminated Zoster. The patient had a history of asthma, hypertension and a history of tubular adenoma. It was noted that the patient presented with shingles rash already diagnosed for antiviral treatment. The patient had an itchy rash on left side of his face and scalp as well as multiple small eruptions on trunk and right arm. The patient had mild headache for last week. Ophthalmologist ruled out ophthalmic involvement. The patient was treated with acyclovir. Lab tests performed included chest X-ray (positive for mild atelectasis, otherwise within normal limits) and CT scan of the abdomen and pelvis (unremarkable). Labs unremarkable. The listing indicated that one or more of the events required hospitalization. No further information is available. The original reporting source was not provided. The VAERS ID number is 328424. 27-Aug-2015: this is a corrected report. The narrative was changed to reflect correct date of vaccination, 02-NOV-2007, and correct date of hospital discharge, 09-Oct-2008.
Age: 19.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Chills, Night sweats, Pain, Pyrexia
Clinical narrative: Fever, chills, night sweats, body aches.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Pt has Induration, erythema, warmth, and pain on the same arm where she received the anthrax immunization. Pt has limited range of range of motion. The area of erythema has gotten larger over 48 hours.
Age: 1.56
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pruritus, Skin warm, Swelling, Urticaria
Clinical narrative: 2.5" red welt, swelling, hot to touch, itching.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Pt called requesting appt.  Pt states the site she received her Tdap injection the other day has become red, hard and warm.  Pt states it is slightly painful.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, VARCEL
Symptoms: Culture, Eczema
Clinical narrative: Patient and her sister both got Varicella vaccine on the same day.  About 3 weeks later their 10 month old brother with a history of severe eczema presented to the clinic with a possible case of varicella. A specimen was collected from one of the lesions which was sent to the lab for identification/verification.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Rash, Speech disorder
Clinical narrative: Patient started passing out after the vaccination. She was conscious, but had difficulty talking. Her face started breaking out with rashes. Administered EPIPEN JR and called 911.
Age: 0.25
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Injection site cellulitis
Clinical narrative: Information has been received from a physician via a field representative referring to a 3 month old female patient with seasonal allergy. On 14-AUG-2015 the patient was vaccinated with her first dose of GARDASIL 9 (0.5 ml/injection; lot# reported as 1007560 with unknown expiration date), intramuscularly (inappropriate schedule of drug administration). Information regarding concomitant medication was not reported. On 21-AUG-2015, the patient experienced cellulitis at the injection site. The patient sought medical attention by calling her doctor. Unspecified treatment was given for the event. No lab diagnostics studies were performed. The outcome of the event cellulitis at the injection site was reported as recovered on an unknown date of August 2015. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Swelling face
Clinical narrative: Patient face started swelling within an hour of recieving vaccines and started with a temperature at 10:00 PM that night. Mom administered 2.5 ml of Tylenol to patient at 10:00 PM. Mom administered Tylenol every four hours. On 08/25/2015 at 8:45 AM patient temperature 102.5 and mom administered 2.5ml Tylenol. Mom called pediatrician office and patient could not be seen that day. Pediatrician advised mom to take patient to Urgent Care or ER. Mom took patient to ER where he was assessed. ER administered patient Tylenol and Benadryl and sent home. ER ordered mom to see pediatrician and follow up with allergist. Patient to be seen week of August 31, 2015 and doctor will then refer to an allergist before next round of vaccines.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Induration, Rash erythematous, Urticaria
Clinical narrative: L arm red and indurated 4cm diameter red rash on arm. Urticaria on forearms and legs
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Was feeling pain, the spot felt hot. The red spot was 1 1/2 inch, pt also was given Benadryl.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Biopsy stomach, Blood test, Cholecystectomy, Decreased appetite
Clinical narrative: In 4/2014 I noticed lack of appetite.   In 5/2014 she started complaining her stomach hurt on a daily basis.  In 6/2014 she was complaining of severe stomach pain.  We took her to emergency room.  We followed up with pediatrician and she sent us to Hospital.  They treated her with many medications.  They did a stomach biopsy on 10/31/2014.  We took her to an allergy doctor to be tested in 2/2015.  We kept going to Hospital.  Then they did a HIDA scan and detected gall bladder stopped functioning.  They took it out 7/2015.  She is still on medications to alleviate stomach pain.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Gallbladder non-functioning, Hepatobiliary scan, Ultrasound biliary tract
Clinical narrative: In 4/2014 I noticed lack of appetite.   In 5/2014 she started complaining her stomach hurt on a daily basis.  In 6/2014 she was complaining of severe stomach pain.  We took her to emergency room.  We followed up with pediatrician and she sent us to Hospital.  They treated her with many medications.  They did a stomach biopsy on 10/31/2014.  We took her to an allergy doctor to be tested in 2/2015.  We kept going to Hospital.  Then they did a HIDA scan and detected gall bladder stopped functioning.  They took it out 7/2015.  She is still on medications to alleviate stomach pain.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Swelling
Clinical narrative: MOC reports that there is redness and induration that is increasing around site of Varicella on Right arm.  Redness and swelling 4"X6".  MOC also reports blistering around injection site.  Recommended that pt be assessed by primary MD.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Significant arm pain in deltoid muscle which has continued 2 weeks later.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Erythema, Fatigue, Tenderness, Vision blurred
Clinical narrative: After receiving the immunization, she noted redness and tenderness at  her arm as well as fatigue. Symptoms were beginning to resolve until 8/23, when she had an episode of dizziness with blurry vision while leaning on church pew, which resolved immediately when she sat back up. Tylenol OTC helps her pain. She did have 1 tablet of 400 mg Motrin however is limited in amount she can take due to history of gastric bypass.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Headache, Hypoaesthesia, Screaming
Clinical narrative: Co-Worker Spoke to mom at 1611.  Child had the meningitis vaccine about 11:00 this morning.  Mother reports that a half hour ago, child developed a "screaming" headache, facial numbness and arm numbness.  Mother suddenly said that she was having trouble breathing.  Mother said they were headed to the ER.  Advised parent to call the ambulance and she immediately hung up.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash all over face neck arms abdomen.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Arthralgia, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: Sore arm. Feels like tendinitis in my left arm where the shot was given and also tendinitis in my left wrist. These symptoms were not present before flu shot was administered. It is now 11 days later and symptoms are still present. Range of motion has been limited with my left arm and this has affected my activities of daily living.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Tendonitis
Clinical narrative: Sore arm. Feels like tendinitis in my left arm where the shot was given and also tendinitis in my left wrist. These symptoms were not present before flu shot was administered. It is now 11 days later and symptoms are still present. Range of motion has been limited with my left arm and this has affected my activities of daily living.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Eye pain, Eyelid function disorder, Insomnia, Ocular hyperaemia
Clinical narrative: Severe pain in right eye. Significant enough that she had difficulty opening eye and was immobilized. Both eyes red. Wanted to fall asleep but had difficulty due to pain. After 1.5 hours fell asleep from pain. Woke up 3 hours later still with pain in eye and unable to open eyes. Fell asleep again and slept till morning. Woke with no pain.
Age: 84.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chest pain, Rash
Clinical narrative: MINOR RASH DEVELOPED ON CHEST AND PATIENT C/O PAIN IN STERNUM AREA.
Age: 1.01
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Cranky and fussy 7/21/15 but resolved 7/22/15.  Left thigh red and swollen and painful 7/21/15 and 7/22/15. Hib and DTap administered left thigh IM.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Infectious mononucleosis, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Extreme fatigue, muscle pain, fever, sore throat.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Feeling abnormal, Pruritus
Clinical narrative: Chest tightness and itching. Pt called a local 24 hour pharmacy at 11:45 and took diphenhydramine oral and remained at home. Continued diphenhydramine the next day, but did not feel she was in her usual health, and visited a walk in clinic the following day. Unknown drugs administered.
Age: 57.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Skin rash, itching to bilateral thighs, bilateral extremities, and bilateral upper hemi-thorax.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: DONOR REPORTED BEING ILL FOR ONE WEEK WITH FEVER, THROWING UP AND RUNNING NOSE.