chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: FLUN4
Symptoms: Pruritus, Skin burning sensation, Urticaria
Clinical narrative: Urticaria 90%+ covered. Burning hands. Severe itching.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Local reaction, Pruritus
Clinical narrative: Post-ZOSTAVAX administration; patient suffered local reaction-significant itching; local reaction approx 4 inches in diameter.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Patient came in 2 days after shot and had large bruise below shot site that was about 2 in x 5 in. Upon follow up; she said it dissipated a little, no pain, or itching.
Age: 74.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Eye pain, Ocular discomfort, Visual impairment
Clinical narrative: Pt. complained of vision problems lasting at least 3 days in (R) eye. Patient unaware if related to vaccine but wanted it noted. Patient stated increased pressure and pain in eye.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Disorientation, Fatigue, Tremor
Clinical narrative: Daughter states night of vaccination, she suffered from fatigue, disorientation, and muscle tremors. No symptoms the next day.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Syncope.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 03-SEP-2015, the patients were vaccinated with improperly stored ROTATEQ lot # K011947, expiration date 07-JUN-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 02-JUL-2015, the patients were vaccinated with improperly stored oral, ROTATEQ lot # K011947, expiration date 07-JUN-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 04-AUG-2015, the patients were vaccinated with improperly stored ROTATEQ lot # K011947, expiration date 07-JUN-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 09-JUL-2015, the patient were vaccinated with improperly stored oral, ROTATEQ lot # K011947, expiration date 07-JUN-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 15-SEP-2015, the patients were vaccinated with improperly stored oral, ROTATEQ lot # K011947, expiration date 07-JUN-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 16-JUL-2015, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # J013370, expiration date 03-FEB-2016 and lot number J0110613, expiration date 11-JUN-2015. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 18-JUN-2015, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # J013370, expiration date 03-FEB-2016 and lot number J0110613, expiration date 11-JUN-2015. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to unknown patients on unknown demographics. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, strength, route unspecified) lot # K018183, expiration date 04-MAY-2016. No adverse symptoms reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. The patient received the first dose of ZOSTAVAX on an unspecified date of November 2014, then received the second dose on an unspecified date of March 2015 (dose, route and lot# were unspecified). No adverse effect was reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from healthcare worker referring to a 16 year old male patient. Concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL 9 (lot #, expiration date, strength and route were not reported). Concomitant medications was not reported. No adverse reactions were reported. It was unknown if the patient sought medical attention. 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 licensed practical nurse and refers to a unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ orally (lot# K022992, expiration date 30-JUN-2016, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a health professional referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On 19-SEP-2015, the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # J000722, expiration date 17-SEP-2015, dose and route were unknown). No known adverse effects were reported. This is one of two reports received from the same patient. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A) refers to multiple unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (route of administration default to oral, dose, lot# and expiration date were not specified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9(lot# L006547, expiration date 04-MAR-2017, dose, site and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A) refers to multiple unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot# and expiration date were not specified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old female patient. The concurrent condition and medical history was not reported. On 19-MAR-2015, the patient was vaccinated with VAQTA lot # K002744, Expiry: 19-SEP-2015, dose 1. The concomitant medication was not reported. On 20-APR-2015, the patient was vaccinated with VAQTA dose 2 of the same lot (inappropriate schedule of vaccine administration). The patient has not experienced any adverse effect. No product quality issue was reported. 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 licensed practical nurse and refers to a unspecified number of patients of unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot# L003193, expiration date 10-NOV-2016, dose, site and route of administration were not reported). No adverse effects were reported. Lot number L003193 has been verified to be a valid number for RECOMBIVAX HB. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAX HIB injection, lot # L006545, expiry date 16-NOV-2017, 0.5 milliliter, intramuscular. No adverse effects reported. No product quality complaint (PQC) was involved. No additional information reported. 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 licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On unspecified dates the patients were vaccinated with improperly stored ZOSTAVAX lot # L006382, expiration date 25-MAY-2016 (dose and route of administration not provided). No concomitant therapies were reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of two reports 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 licensed practical nurse and refers to a unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical histories, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with improperly stored VAQTA (lot# L014068, expiration date 02-NOV-2017, dose, site and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On approximately 15-SEP-2015 ("about one week ago") the patient was vaccinated with a dose of ZOSTAVAX (dose, lot # and route were not reported) by an unspecified physician. On or about 20-SEP-2015, the patient developed what the patient's primary care physician (unspecified physician) presumed as shingles. the primary care physician then prescribed an unspecified dose and frequency of VALTREX to treat the shingles. At the time of this report, the event outcome was unknown. The causality between the event and the vaccine was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a currently 18 year old pregnant female patient. There were no concomitant medications, concurrent conditions and medical history reported. Physician reports that during a routine prenatal visit on 11-SEP-2015, the patient's boyfriend stated that the patient "had received a bunch of vaccinations recently". Physician reported that one dose of GARDASIL (dose, lot number and expiration date were not reported) had been administered to the patient on 03-JUL-2015 by the patient's primary care physician who was unspecified. Physician stated that the patient was "doing well" at the time of the report. Physician stated that she provided no treatment to the patient. The patient became pregnant with last menstrual period (LMP) of 12-JUL-2015 and estimate delivery date (EDD) of 17-APR-2016. The pregnancy outcome was pending. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified female patient of unknown age. Pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with first dose of GARDASIL, (lot #, dose, frequency and route not provided) and in 2014 (also reported as a year ago), the patient received the 2nd dose of GARDASIL. On 22-SEP-2015 (today), the patient was currently in the office to receive her third dose of GARDASIL; which was outside of the recommendations in the GARDASIL prescribing information. No adverse effects reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was inadvertently vaccinated with the fourth dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. The patient did not seek medical attention. There was no product quality complaint (PQC) involved. Additional information is not expected as the reporter declined any further contact.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site discolouration
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to her daughter, an 11 year old female patient. The patient had no pertinent medical history and no drug allergies. On an unknown date the patient was vaccinated with the second dose of GARDASIL 9 (0.5 ml, intramuscular, lot # not provided). There were no concomitant medications. It was reported that (till the reporting time), the patient's arm had been "black and blue" around the injection site for seven days (onset date estimated to be 20-AUG-2015). The patient did not seek medical attention. No treatment was given. No lab diagnostics studies were performed. The medical assistant reported that her daughter would continue with the series of GARDASIL 9. The outcome was reported as recovering. 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 a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 09-SEP-2015 the patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (lot # L003777, expiration date 04-FEB-2017, dose and route were not reported). Concomitant drug was not reported. No adverse reactions were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored (Merck) VARIVAX (lot # K007981, expiration date 03-JUN-2016; strength, dose and route not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of  unknown age and gender. No relevant medical history  or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored ROTATEQ (lot # K009901, expiration date 08MAY2016; strength and dose not reported) orally. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a 2 month old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was not reported. The patient was vaccinated with the first dose of RECOMBIVAX HB (strength, dosage and route unspecified) on 20-JUL-2015, the second dose of RECOMBIVAX HB (strength, dosage and route unspecified) on 21-AUG-2015 and the third dose of RECOMBIVAX HB (strength, dosage and route unspecified) on 21-SEP-2015 (inappropriate schedule of vaccine administration). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from a healthcare professional referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. The patient received the first dose of VAQTA on 16-SEP-2014 and the second dose of VAQTA on 26-NOV-2014 (strength, dosage, frequency and route unspecified) (inappropriate schedule of vaccine administration). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a health professional referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On 18-SEP-2015, the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # J000722, expiration date 17-SEP-2015, dose and route were unknown). No known adverse effects was reported. This is one of two reports received from the same patient. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 5 year old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions were provided. On an unknown date, the patient was vaccinated with the first dose of PROQUAD (Merck) injection (lot# reported as K011310, expiry date 14-FEB-2016; dose and route of administration were not reported). Then, 34 days later (date unspecified), the patient received the second dose of PROQUAD (Merck) injection (lot# reported as K011310, expiry date 14-FEB-2016; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. 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 nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (route of administration not reported) lot # L011537, expiration date 03-JUL-2015, that was improperly stored. There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reactions/allergies reported. Since 15SEP2015, doses of improperly stored ROTATEQ (lot # K019370 with 16NOV2016, dose, frequency and route were unknown) were administered to an unspecified number of patients. No concomitant therapy was reported. No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. There was no medical history or drug reactions/allergies reported. On 22-SEP-2015, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23 (lot# K004487 with expired date 21-AUG-2015, dose, frequency and route were unknown). No concomitant therapy was reported. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M. A.) refers to multiple unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot# and expiration date were not specified). 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
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored (in temperature 34-35 - unit unknown) unspecified doses of ROTATEQ lot#K016275, expiry date 20-APR-2016 or lot# reported as L004453, expiry date 27-MAY-2016 (dose, site and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, Laboratory test, Malaise
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 15 year old male patient. Concurrent or medical conditions were not reported. On 19-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular, lot # reported as L000610, expiration date 31-JAN-2017 (dose and strength were not reported) for papilloma viral infection. Secondary suspect and concomitant therapies were not reported. On 20-AUG-2015 (reported as a day later), the patient began to feel "joint pain and malaise". On the same day, the patient had various unspecified lab work (result was not reported). The outcome of joint pain and malaise were not reported. It was reported that the patient sought medical attention by a visit office. The events did not required intervention to prevent serious criteria, did not product significant disability or incapacity, did not required hospitalization and it were not life threatening for the patient. No product quality complain was reported. Additional information has bee requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored (in temperature 34-35 -unit unknown) unspecified doses of PNEUMOVAX23 (lot#K020214, expiry date 25-MAR-2016 or lot # K021030, expiry date 22-JUN-2016 or K016264, expiry date 28-APR-2016 or lot # K021881, expiry date 30-JUL-2016 (dose, site and route of administration were not 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
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored (in temperature 34-35 - unit unknown) unspecified doses of PROQUAD (Merck) lot # K023862, expiry date: 25-MAY-2016 or lot# L011079, expiry date: 01-OCT-2016 or lot# L004006, expiry date: 05-AUG-2016 (dose, site and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a medical assistant refers to 2 patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unspecified date, the patients were vaccinated with doses of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. On an unknown date, after receiving GARDASIL, the patients developed reactions "similar" to the patient, who experienced soreness "1 to 2 inches in diameter" around the GARDASIL injection site (captured in MARRS# 1509USA002672). The outcome of the event was not reported. The relatedness between GARDASIL and the event was not provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 21 year old male patient with penicillin allergy. The patient had no pertinent medical history. On 02-MAY-2013, the patient was vaccinated with the first 0.5 ml dose of GARDASIL intramuscular injection (lot # 0420AE, expiry date 01-DEC-2014). On 17-AUG-2015, the patient was vaccinated with the second 0.5 ml dose of GARDASIL intramuscular injection (lot # K016966, expiry date 10-MAY-2017). Concomitant therapies included ADDERALL. On an unknown date, after receiving the second dose of GARDASIL, the patient developed soreness, 1 to 2 inches in diameter, around the injection site. The patient sought medical attention-he was seen in the office on an unspecified date. No treatment was given for the event and no diagnostic lab studies were performed. The outcome of the event was reported as not recovered. The relatedness between GARDASIL and the event was not provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist, as part of a marketing research program, refers to a 60 year old female patient. Information about patient's concomitant medications, concurrent conditions and medical history reported was unknown. In March 2015, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (lot, expiry date, dose, site and route were not reported). In March 2015, the patient experienced redness, itchiness at the injection site. The outcome of the events was reported as recovered in March 2015 (it was reported that AE dismissed after stopping suspect drug therapy). The reporter considered the events to be related to ZOSTAVAX. Additional information is not expected as the reporter did not give a consent to disclose personal details.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Rash
Clinical narrative: Myalgia and skin rash.
Age: 60.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a 60 year old male patient with unspecified thyroid condition and unspecified drug allergy. On 15-SEP-2015, the patient was vaccinated with a single dose of ZOSTAVAX 0.65 ml, subcutaneous injection and unspecified pneumonia shot. Concomitant therapies included unspecified thyroid medication. On 17-SEP-2015, the patient developed rash that had spread all over his arm (arm unspecified). The patient decided to take BENADRYL on his own. The patient did not seek medical attention. No lab diagnostic test was performed. At the time of the report, the patient did not recovered from rash. Relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored (at the temperature of 34-35-unit unknown) unspecified doses of PEDVAXHIB (lot # K0256533, expiry date 07-AUG-2017 or lot # K015463, expiry date 10-JUL-2017)(dose, site and route of administration were not provided). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored (at the temperature of 34-35 - unit unknown) unspecified doses of ZOSTAVAX lot # L002424, expiry date 23-APR-2016 or lot# L012476, expiry date 10-JUL-2016 or lot# L012477, expiry date 10-JUL-2016 (dose, site and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt reported to our clinic 1 day after vaccine (PNEUMOVAX) received. He complained of an extremely sore arm/unable to lift the arm until following morning. The pain is reduced and he moves it freely now. Took pain meds and applied ice packs. No redness, swelling or infection.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received dose of ZOSTAVAX and had also had this same vaccine 1 year ago, this is to be a one time vaccine. Injection site itchy, swollen.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Per Dr. - Patient had syncopal event after GARDASIL approx. 15 minutes later. No injury recovered within 5 min.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives around (R) eye, hives to (L) side of face and neck. Pt given CLARITIN. Signs/symptoms resolved.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Mass, Peripheral swelling
Clinical narrative: Patient had a reaction to a Tdap injection, redness swelling to upper arm, lump under the skin. 25 x 20 mm. Patient told to ice area and take Ibuprofen 800 mg q 8 hrs.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Child administered vaccines on 9/14/15 - mom states the following day she noticed her right leg was red and at daycare/ Today (9/16/15) mom reports the leg (right) was very swollen, red, and warm to the touch. She sought medical attention at the child's pediatrician.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance refers to an unspecified patients of unknown ages and genders. Concurrent condition and medical history were not reported. On 22-SEP-2015, the patients were vaccinated with an expired dose of ZOSTAVAX lot # J014851, expiration date on 24-OCT-2014 (strength, dose, anatomical location and route of administration were not reported). There was not a product quality complaint (PQC) involved. No adverse effect was reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Body temperature increased, Fatigue, Headache, Pruritus
Clinical narrative: After pt. received 2nd varicella vaccine at 8:30 A.M. she noticed at 1 p.m. that her legs were itching. She raised her pant legs and had approximately 15 fluid filled vesicles on legs. During the night, she had a temp of 101.3 degrees, headache and fatigued today 9-24-15. Pt may go to the doctor today - 9-24-15 if symptoms persist. 9-24-15, Pt reported back to the Health Dept and stated she went to the doctor. Her BP was 142/96 and she still has the fluid filled vesicles. She was advised to stay out of school x 2 days and was prescribed steroids to take.
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 27-MAY-2015, the patient was vaccinated with the first dose of ROTATEQ by oral route (dose, lot# and expiration date were not reported). On 09-SEP-2015, the patient received an improperly stored second dose of ROTATEQ oral, lot# K013410, expiration date 27-FEB-2016 (dose, was not reported). No adverse symptoms were reported. It was unknown if the patient sought medical attention. No product quality complaint was involve. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Infection, Rash
Clinical narrative: Huge rash, infection from shoulder to under elbow on right arm. Patient was given KEFLEX 500 TID.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Foetal disorder, Insomnia, Nausea, Pain in extremity
Clinical narrative: Vaccine given 9-15-15 AM. Arm very sore that night, not able to sleep. Nausea 9-16-15. Reports continued (n/v) nausea on 9-17-15 and also had decreased fetal movement. Was evaluated at labor and delivery for fetal well-being. She had a reactive fetal monitor strep and then discharged.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Exposure during pregnancy, Foetal disorder, Nausea, Pyrexia
Clinical narrative: Had vaccine 9-15-15 AM, that evening started having N/V, chills, felt feverish, able to drink fluids only. Went to ER 9-16-15 AM and was sent to Labor and Del. Also had decreased FM noticed around 2-3 AM 9-16-15. Given anti-nausea meds and observed for a few hours. Had reactive non stress test for baby.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Had vaccine 9-15-15 AM, that evening started having N/V, chills, felt feverish, able to drink fluids only. Went to ER 9-16-15 AM and was sent to Labor and Del. Also had decreased FM noticed around 2-3 AM 9-16-15. Given anti-nausea meds and observed for a few hours. Had reactive non stress test for baby.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown dates, the patients received doses of improperly stored (Merck) VARIVAX (lot #K008818 with expiration date on 19-JUN-2016; lot #L001331 with expiration date on 13-JAN-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. 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 physician concerning multiple unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of (Merck) VARIVAX (Lot No. L010146 Expiration date: 24-MAR-2017, L017142 Expiration date: 13-MAY-2017 and Lot No. reported as J013732) (dose, route and anatomical location of administration were not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 1 day after giving vaccine, right thigh had swelling, redness. No fever.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal stiffness, Myalgia, Pain in extremity, Skin warm
Clinical narrative: Administered PNEUMOVAX 23 9/21/15 pt tolerated well, pt called office 9/22/15 at 8:30am reported (L) arm stiffness and pain. Was advised to do warm compresses BID PRN pain 10-15 min each time and ok to take ibuprofen or TYLENOL. Pt walked into office 9/23/15 with c/o (L) arm pain, warm to touch, muscle pains, and redness to elbow. Pt was seen by Dr. and prescribed KEFLEX oral. Advised to use cold compresses, BENADRYL PRN and Ibuprofen PRN pain and to call PRN if not better or worse.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local rxn at (R) deltoid muscle w/ red, raised erythematous about 8 cm in diameter. Rxn milder on (L) deltoid about 3 cm in diameter. Seen in ED, started on BACTRIM, ibuprofen, and cold compresses. D/C BENADRYL and triamcinolone ointment.
Sex: M
Vaccine: MMRV
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a nurse refers to a male child of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with PROQUAD (lot # K007800, and expiration date 29-NOV-2015) subcutaneous in the left arm. While administering the vaccine the hub of the needle was not twisted down and half of the vaccine leaked out around it. So only half of the 0.5 ml dose was administered. No adverse effects reported. Nurse stated that he will re administer the vaccine. Action taken was not applicable. The outcome of events was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information is not expected as the reporter did not wish further contact.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Pain, Swelling
Clinical narrative: Stabbing pain (L) axilla. Swelling supraclavicular region.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, Hepatitis B antibody negative, Immunisation, No adverse event, No therapeutic response
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a child female patient who received ENGERIX B pediatric. Co-suspect products included ENGERIX B pediatric, ENGERIX B pediatric and ENGERIX B pediatric (batch number N45BR, expiry date 3rd September 2015). On an unknown date, the patient received the 1st dose of ENGERIX B pediatric, the 2nd dose of ENGERIX B pediatric and the 3rd dose of ENGERIX B pediatric. On 16th September 2015, the patient received the 5th dose of ENGERIX B pediatric .5 ml. On 16th September 2015, not applicable after receiving ENGERIX B pediatric, ENGERIX B pediatric and ENGERIX B pediatric and an unknown time after receiving ENGERIX B pediatric, the patient experienced expired vaccine used. On an unknown date, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and expired vaccine used were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B pediatric, ENGERIX B pediatric and ENGERIX B pediatric. Additional details provided were as follows: On unspecified dates, as a child, the patient received 3 doses of ENGERIX B pediatric. On an unknown date, the patient performed test for Hepatitis B antibody, which was found to be negative, causing the patient to be a non-responder to therapy. On an unknown date, the patient was revaccinated with ENGERIX B pediatric as a 4th dose. On 16th September 2015, at 10:30, the patient received 5th dose in series (2nd dose of revaccination), which had already expired on 3rd September 2015. There were no adverse events reported till date.
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Injection site irritation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is a prospective pregnancy case. This 19-year-old female subject was enrolled in an open label study, a prospective, exploratory study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with BOOSTRIX during pregnancy or within 28 days preceding conception. The subject received BOOSTRIX .5 ml on an unknown date. The subject's estimated date of delivery was 1st OCTOBER 2015. On 9th SEPTEMBER 2015, an unknown time after receiving BOOSTRIX, the subject developed injection site warmth (non-serious). Additional event(s) included injection site tenderness on 9th SEPTEMBER 2015, injection site swelling on 9th SEPTEMBER 2015 and vaccine exposure during pregnancy. The outcome of injection site warmth was recovering/resolving. The outcome(s) of the additional event(s) included injection site tenderness (unknown), injection site swelling (recovering/resolving) and vaccine exposure during pregnancy(unknown). The pregnancy is ongoing. It was unknown if the investigatory considered the injection site warmth, injection site tenderness and injection site swelling to be related to BOOSTRIX. Additional details provided were as follows: On unknown date, the patient received a dose of BOOSTRIX vaccine (batch number: NL7K3, expiry date: 15th SEPTEMBER 2017) and was exposed to the vaccine at an unknown trimester. The last menstrual date of the patient was not provided. On 9th SEPTEMBER 2015, an unknown time after receiving the BOOSTRIX,, the patient experienced warm to touch, tenderness, and swollen at injection site. The patient reported to healthcare professional that the events were subsiding, but still irritated.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a first dose of RECOMBIVAX HB. Then on an unknown date, the patient received late the second dose of RECOMBIVAX HB (dose, route, lot # and expiration date were not provided). No adverse symptoms reported. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: From physician note on 9/11/15: Pt came to clinic per my request to check his (L) arm. He received pneumonia vaccine on 9/8/15. Noticed redness yesterday. No pain. Exam: (L) posterior upper arm; + red, warm area with induration at center, + a red streak toward anterior arm. + tattoo on anterolateral (L) upper arm. Doxycycline 100 mg BID.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Induration, Mass, Pruritus, Skin warm
Clinical narrative: 5 in x 5 in red hard hot lump itchy.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Warmth, redness, tender around injection site. Ibuprofen/cool compress.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site.
Age: 1.05
Sex: F
Vaccine: MMR
Symptoms: Full blood count normal, Rash, Streptococcus test negative
Clinical narrative: Between 1 and 3 days after 12 month vaccines, she broke out in a rash. The rash went away and came back in 2 wks. It disappeared again and came back in 1 month. Provider believes it could be MMR related.