chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site rash, Rash, Rash pruritic
Clinical narrative: Information has been received from a pharmacist via company representative concerning a 61 year old female patient with hypertension. The patient's medical history included shingles three years ago. Information about her drug allergies and previously drug reactions were not reported. She had not concomitant medication. On 30-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose number, dose, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unspecified date in 2017, after ZOSTAVAX vaccination, the patient developed "a rash across the back" and her primary care physician diagnosed her with a case of the shingles. The primary care physician felt the shingles was due to the vaccine and as treatment; the patient was prescribed a regimen of VALTREX. At the time of the report, the patient was not recovered from the shingles, it was unknown if lab diagnostics studies were performed and the pharmacist did not provide a causal relationship between the shingles and ZOSTAVAX vaccination.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a pharmacist via company representative concerning a 61 year old female patient with hypertension. The patient's medical history included shingles three years ago. Information about her drug allergies and previously drug reactions were not reported. She had not concomitant medication. On 30-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose number, dose, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis. On an unspecified date in 2017, after ZOSTAVAX vaccination, the patient developed "a rash across the back" and her primary care physician diagnosed her with a case of the shingles. The primary care physician felt the shingles was due to the vaccine and as treatment; the patient was prescribed a regimen of VALTREX. At the time of the report, the patient was not recovered from the shingles, it was unknown if lab diagnostics studies were performed and the pharmacist did not provide a causal relationship between the shingles and ZOSTAVAX vaccination.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Induration, Limb mass, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 69 year old female patient. In the morning of 13-JUN-2017, the patient was vaccinated with PNEUMOVAX23 lot # N004564, expiration date 22-OCT-2018, intramuscular in the left deltoid for prevention of pneumococcal disease. On the evening of 13-JUN-2017, the patient peripheral swelling, pruritus and erythema. The outcome of erythema and pruritus was reported as recovered on 14-JUN-2017. The outcome of peripheral swelling was reported as not recovered/not resolved. The relatedness between the events and PNEUMOVAX23 was not reported. This is one of two reports received from the same reporter. Sender's Comments:  US-009507513-1707USA000718.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 69 year old female patient. In the morning of 13-JUN-2017, the patient was vaccinated with PNEUMOVAX23 lot # N004564, expiration date 22-OCT-2018, intramuscular in the left deltoid for prevention of pneumococcal disease. On the evening of 13-JUN-2017, the patient peripheral swelling, pruritus and erythema. The outcome of erythema and pruritus was reported as recovered on 14-JUN-2017. The outcome of peripheral swelling was reported as not recovered/not resolved. The relatedness between the events and PNEUMOVAX23 was not reported. This is one of two reports received from the same reporter. Sender's Comments:  US-009507513-1707USA000718.
Age: 15.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a 15 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-JUN-2017, the patient was vaccinated with PROQUAD subcutaneously, lot # M041509, expiration date 09-APR-2018 (dose was not reported). No side effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a 15 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-JUN-2017, the patient was vaccinated with PROQUAD subcutaneously, lot # M041509, expiration date 09-APR-2018 (dose was not reported). No side effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral mucosal eruption, Rash
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 66 years-old female patient. The patient's medical history and concurrent conditions were unknown by the reporter. The patient had no drug allergy listed. Her concomitant medications included ciclopirox and AMLACTIN. On 19-APR-2017, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) vial with lot # M039453 and expiration date on 19-DEC-2017 (dose, route of administration and anatomical location were not provided), reconstituted with a sterile diluent injection (lot #, expiration date, strength, dose, route of administration were not reported), for prophylaxis. In approximately May 2017 (reported as "about a month after"), the patient noticed small rash/bumps around the corner of her mouth that looked like cold sores. It was reported that she kept getting rash around the corner of her mouth and at the time of this report there was some rash present on her chin too. The patient had not seen the physician yet. It was unknown if treatment was given for the events or if laboratory diagnostics studies were performed. The outcome of the oral herpes and the rash was unknown. The casual relationship between the oral herpes and the rash with ZOSTAVAX was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes, Oral mucosal eruption
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 66 years-old female patient. The patient's medical history and concurrent conditions were unknown by the reporter. The patient had no drug allergy listed. Her concomitant medications included ciclopirox and AMLACTIN. On 19-APR-2017, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) vial with lot # M039453 and expiration date on 19-DEC-2017 (dose, route of administration and anatomical location were not provided), reconstituted with a sterile diluent injection (lot #, expiration date, strength, dose, route of administration were not reported), for prophylaxis. In approximately May 2017 (reported as "about a month after"), the patient noticed small rash/bumps around the corner of her mouth that looked like cold sores. It was reported that she kept getting rash around the corner of her mouth and at the time of this report there was some rash present on her chin too. The patient had not seen the physician yet. It was unknown if treatment was given for the events or if laboratory diagnostics studies were performed. The outcome of the oral herpes and the rash was unknown. The casual relationship between the oral herpes and the rash with ZOSTAVAX was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a other health professional refers to a female patient of unknown age. On 20-JUN-2017 the patient was vaccinated with VARIVAX lot # M047661 for prophylaxis. The patient became pregnant. The LMP and EDD is not known. The patient delivered a {Enter Gender} infant. The pregnancy outcome was outcome pending. On an unknown date the patient experienced exposure during pregnancy and no adverse event. The outcome of exposure during pregnancy and no adverse event is unknown. The reporter considered exposure during pregnancy and no adverse event to be not related to VARIVAX.     {Additional information has been requested. / Additional information is not expected.}
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphagia, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a 64 year old female patient refers to herself. The patient had drug allergy to morphine and no other pertinent medical history. On 26-MAY-2017 the patient was vaccinated with ZOSTAVAX, subcutaneously (dose and lot # not reported) for shingles prophylaxis. Concomitant therapies included unspecified hormone patch. Later that day the patient reported that her arm was itchy and there was a rash over two inches long at the injection site. The next day, 27-MAY-2017, the size of the rash increased to over eight inches long. On 28-MAY-2017 the size of the rash increased to over eight inches long. The patient called her physician who prescribed BENADRYL and advised the patient to use hydrocortisone cream on the rash. On 29-MAY-2017 the size of the rash increased to over 12 inches long and her face was swollen and felt hot. The patient went to emergency room and was prescribed methylprednisolone and PEPCID. The patient recovered on a unknown date in 2017. There were no lab tests performed. The relatedness between ZOSTAVAX and adverse events was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a 64 year old female patient refers to herself. The patient had drug allergy to morphine and no other pertinent medical history. On 26-MAY-2017 the patient was vaccinated with ZOSTAVAX, subcutaneously (dose and lot # not reported) for shingles prophylaxis. Concomitant therapies included unspecified hormone patch. Later that day the patient reported that her arm was itchy and there was a rash over two inches long at the injection site. The next day, 27-MAY-2017, the size of the rash increased to over eight inches long. On 28-MAY-2017 the size of the rash increased to over eight inches long. The patient called her physician who prescribed BENADRYL and advised the patient to use hydrocortisone cream on the rash. On 29-MAY-2017 the size of the rash increased to over 12 inches long and her face was swollen and felt hot. The patient went to emergency room and was prescribed methylprednisolone and PEPCID. The patient recovered on a unknown date in 2017. There were no lab tests performed. The relatedness between ZOSTAVAX and adverse events was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Injection site rash, Pruritus, Swelling face
Clinical narrative: This spontaneous report as received from a 64 year old female patient refers to herself. The patient had drug allergy to morphine and no other pertinent medical history. On 26-MAY-2017 the patient was vaccinated with ZOSTAVAX, subcutaneously (dose and lot # not reported) for shingles prophylaxis. Concomitant therapies included unspecified hormone patch. Later that day the patient reported that her arm was itchy and there was a rash over two inches long at the injection site. The next day, 27-MAY-2017, the size of the rash increased to over eight inches long. On 28-MAY-2017 the size of the rash increased to over eight inches long. The patient called her physician who prescribed BENADRYL and advised the patient to use hydrocortisone cream on the rash. On 29-MAY-2017 the size of the rash increased to over 12 inches long and her face was swollen and felt hot. The patient went to emergency room and was prescribed methylprednisolone and PEPCID. The patient recovered on a unknown date in 2017. There were no lab tests performed. The relatedness between ZOSTAVAX and adverse events was not reported. Additional information has been requested.
Age: 1.42
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Abnormal behaviour, Crying, Dyskinesia, Mobility decreased, Screaming
Clinical narrative: Constant sleeping and crying for first week. Screaming in the middle of the night ever since. Had to take him to the emergency room on March 22, 2017 because he woke early in the morning screaming and could not move. Some nights, while sleeping, he is flat on his back, straight and shaking/jolting. Possible seizures. Always wakes screaming. Since the most recent incidence on 7/5/2017, he has been walking into walls and randomly collapsing.
Age: 1.42
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Somnolence, Syncope, Tremor
Clinical narrative: Constant sleeping and crying for first week. Screaming in the middle of the night ever since. Had to take him to the emergency room on March 22, 2017 because he woke early in the morning screaming and could not move. Some nights, while sleeping, he is flat on his back, straight and shaking/jolting. Possible seizures. Always wakes screaming. Since the most recent incidence on 7/5/2017, he has been walking into walls and randomly collapsing.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Chicken pox like rash spreading throughout child's face and body.
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, referring to a 64 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. Approximately on 03-MAY-2017 (reported as: " 3 to 4 weeks ago"), the patient was vaccinated with a dose of ZOSTAVAX (strength, dose number, route, anatomical location, lot# and expiration were provided) for prophylaxis, reconstituted with sterile diluent (lot# and expiration were provided). In approximately May 2017 (reported as: "On an unknown date after received ZOSTAVAX"), the patient experienced hair loss. It was unknown if the patient had received any treatment for alopecia. At the time of the report, the outcome of alopecia was unknown. The reporter did not assess the relatedness between the event and suspect therapy.
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Malaise, Syncope
Clinical narrative: This spontaneous report was received from a Pediatrician through her husband, who also was a Pediatrician, via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (strength, route of administration, anatomical location, lot # and expiration date were not reported) for prevention of Human Papilloma Virus (HPV). It was reported that, after the patient was vaccinated with this first dose, she fainted and then fully recovered within the same office visit. As a precaution at the scheduled second dose with GARDASIL 9 (strength, route of administration, anatomical location, lot # and expiration date were not reported) for prevention of HPV, the physician administered this dose, on an unknown date, while the patient was lying down, but the patient immediately stated that "she felt sick" (not specified the description of sickness). This malaise lasted the entire day before she recovered. The patient was not hospitalized and it was unknown if she received any treatment for the adverse experiences. The causality assessment between the syncope and malaise, and vaccination with GARDASIL 9 was not provided.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 15 year old female patient. The patient's concurrent conditions included Crohn's disease, GERD (gastroesophageal reflux disease) and asthma. The patient was lactose intolerant. On unknown dates, the patient received the first and second dose of VARIVAX as prophylaxis (dose, strength, route of administration, lot number and expiration date were not reported) with sterile diluent (manufacturer unknown) (dose, route of administration, lot number and expiration date were not reported). The patient's concomitant medications included several unspecified medications. On 24-MAY-2017, the patient received laboratory testing where it was found that the patient did not seroconvert to varicella (antibody test negative). The registered nurse reported that the patient received an unspecified treatment for the event. The outcome of antibody test negative was unknown. The reporter did not provide the causality between the event, VARIVAX and sterile diluent (manufacturer unknown). This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1706USA004391.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue
Clinical narrative: This spontaneous report has been received from a pharmacist, concerning an unspecified patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX lot # N009167 an expiration date 28-FEB-2018 (strength, dose number, route of administration and anatomical location were not provided) for prophylaxis, which was reconstituted with an sterile diluent (manufacturer unknown) lot #L006550 and expiration date 02-NOV-2017 or lot # L025374 and expiration date 27-MAR-2018. The reporter stated that while drawing ZOSTAVAX into plastic syringe, primary reporter reported that some of the vaccine was leaking out from the site where the needle was screwed into the plastic syringe. No adverse effect reported. There was no product quality complaint involved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, any known allergies or reactions and pertinent medical history. On 06-JUN-2017, the patient was vaccinated with an expired dose of M-M-R II (lot # L020189 with expiration date of 03-JUN-2017), administered subcutaneously, for prophylaxis (dose was not reported); which was diluted with sterile diluent (MRK INJ). No adverse effects were reported. No product quality complaint was involved.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 89 year old male patient. The patient's medical history or concurrent conditions were not reported. It was reported that the patient had no drug reactions or allergies. Concomitant therapies included torsemide, clopidogrel, metoprolol, pantoprazole, nitroglycerin (manufacturer unknown), metolazone, simvastatin (manufacturer unknown) and tamsulosin hydrochloride. On 06-JUN-2017 (reported as "administered today"), the patient was vaccinated with a dose of ZOSTAVAX lot number m037014 with expiration date on 22-NOV-2017, dose 1, (therapy route reported as "injected vaccine") (anatomical location, administration route were not reported) for shingles. Subsequently, on the same date that the patient was vaccinated, he called the pharmacist stating he was experiencing back pain. The pharmacist reported that the patient was evaluated by his physician regarding his back pain, but no details of the physician office visit were provided. At the time of the report the outcome of the back pain was unknown. The pharmacist did not mention the causality assessment between the back pain and therapy with ZOSTAVAX. There was no product quality complaint involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to multiple unspecified number of patients of unknown ages and genders. The patients' concurrent conditions, medical history and concomitant medications were not provided. On an unspecified date in 2015, the patients were vaccinated with improperly stored doses of ROTATEQ administered orally (strength, dose, lot # and expiration date were not provided) for prophylaxis. It was stated that the vaccines were improperly stored at 34 Fahrenheit degrees for 15 hours and no digital data logger was involved. No adverse effects reported.
Sex: U
Vaccine: DTAP, HEPA, MMRV, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to an approximately 22 month old patient. On an unknown date the patient was vaccinated with PROQUAD dose 1 for prophylaxis. Concomitant therapies included PREVNAR 13, hepatitis a vaccine, inactivated (manufacturer unknown) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(manufacturer unknown). On an unknown date the patient experienced product use issue and no adverse event. The outcome of product use issue and no adverse event was unknown. The reporter considered product use issue and no adverse event to be not related to PROQUAD.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA lot # N005274, expiration date 03-APR-2018 (dose and route of administration were not provided) for prophylaxis. The patients' concomitant medication were not reported. On an unspecified date, the VAQTA were exposed to temperature ranges between 32° Fahrenheit (F) to 35°F during a time frame of 4 hours. There was not previous temperature excursion, the temperature excursion was not called by a data logger. Adverse effects were not reported. This is one of two reports received from the same source. Sender's Comments: US-009507513-1706USA003492.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and certified medical assistant referring to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, pertinent medical history and concomitant therapies. On unknown dates in 2017, the patients were vaccinated with improperly stored doses of with GARDASIL 9 lot # N002720 and expiration date 12-MAY-2019 (route, dose, dose number and anatomical location were not provided) for prophylaxis. Since April 2017, this vaccine was cumulatively exposed from 47 to 77 degrees Fahrenheit for 108 hours plus 32 to 35 degrees Fahrenheit for 195 hours and 15 minutes. Data logger was involved and there was no previous temperature excursion. No adverse effects reported. No Product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1706USA011005: US-009507513-1706USA011006.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Extra dose administered
Clinical narrative: This spontaneous report as received from an other health professional refers to an approximately 11 year old female patient with migraine and no known allergies. On 07-JUN-2017 the patient was vaccinated with VARIVAX dose 3 for prophylaxis. Concomitant therapies included IMITREX. In 2008 the patient experienced product use issue. On 07-JUN-2017 the patient experienced off label use. In June 2017 the patient experienced antibody test negative. The patient received tretament. However, she did not seek medical attention. The outcome of antibody test negative was reported as recovered/resolved, also reported as "She's fine". The outcome of product use issue and off label use is unknown. The reporter considered product use issue and off label use to be not related to VARIVAX.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant concerning an unspecified patient of unknown age and gender. There was no information patient's medical history, drug allergies, previously drug reactions, concurrent conditions or concomitant medication. On 24-MAY-2017, the patient were vaccinated with an improperly stored ROTATEQ orally, lot number M012495 with expiration date of 09-OCT-2017 (strength, dose, dosage schedule and anatomical location were not provided) for prophylaxis, and the administered dose was exposed to a temperature between 32°F to 35°F (digital data logger) for 13 hours and 42 minutes without any previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided. On 20-NOV-2012, the patient was vaccinated with a dose of M-M-R II (strength, dose, administration route, anatomical location, lot number and expiration date were not reported) for prophylaxis, which was reconstituted with water, sterile (manufacturer unknown) (also reported as "sterile water diluent") (lot number and expiration date were not reported), and a dose of VAQTA (strength, dose, administration route, anatomical location, lot number and expiration date were not reported) also for prophylaxis; two days before the patient turned one year old. No adverse effects were reported. There was no product quality complaint involved.
Sex: M
Vaccine: HPV9
Symptoms: Infertility male
Clinical narrative: This spontaneous report was received from a physician referring to an unspecified number of male patients of unknown age. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with doses of GARDASIL 9 for prophylaxis (dose, route, lot # and expiration date were not reported). The reporting physician stated that she had been informed by an unspecified person "a report that stated that GARDASIL 9 could make males sterile so they should not received". At the time of reporting the outcome of infertility male was unknown. A product quality complaint was not involved. The causality assessment between Infertility male and GARDASIL 9 was not provided.
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) concerning a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and allergies were not reported. It was reported that on 21-JUL-2014, the patient was administered his first dose of GARDASIL (Lot # H020901; expiration date 05-JUL-2015) (dose and route were not reported); on 07-NOV-2014, he received his second dose of GARDASIL (Lot # H020901; expiration date 05-JUL-2015) (dose and route were not reported); on 07-APR-2015, he was administered his third dose of GARDASIL (Lot # L001442; expiration date unknown) (dose and route were not reported). It was reported that on 28-FEB-2017, the patient was then administered a fourth dose of GARDASIL 9 (Lot # M041213; expiration date unknown) (dose and route were not reported). No adverse effect was reported. There was no PQC involved.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling
Clinical narrative: Information has been received from a nurse via a company representative reporting on an 88 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient received an unspecified dose of PNEUMOVAX23 (route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced an allergic reaction at the injection site. The injection site became red and swollen. The patient was given BENADRYL by a health care provider and recovered within 24 hours. The causal relationship between injection site swelling and injection site redness and therapy with of PNEUMOVAX23 was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with a dose of improperly stored ZOSTAVAX, for prophylaxis. No adverse effects reported.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous retrospective pregnancy report was received from an unknown age female patient concerning herself. The patient's pertinent medical history, concurrent conditions and allergies were not provided. On an unknown date, prior to her pregnancy, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) as prevention from the varicella virus (dose, Lot # and frequency were not reported). Secondary suspect and concomitant medications were not reported. The last menstrual period and estimated delivery date were unknown at the time of the report. On an unknown date, the patient delivered a baby (unspecified demographics and outcome). It was reported that the patient was not pregnant at the reporting time. The patient reported that her physician recommended a "booster" of an unspecified varicella vaccine because her "titers were low when she was pregnant". The outcome of varicella virus test negative was unknown as well as the causal relationship between this event and varicella virus vaccine live (oka/merck) (manufacturer unknown). There was no PQC involved.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist and refers to an elderly male patient of unknown age and gender. Information regarding the patient's medical history and concomitant medications was not provided. The pharmacist reported that on 24-MAY-2012 the patient was vaccinated with a dose of PNEUMOVAX 23, then on 08-JAN-2016, the patient received a dose of PREVNAR 13, and then, on 12-JUN-2017 the patient received another dose of PNEUMOVAX 23 for prophylaxis. Strength, dose, route, lot number and expiration date for all the administered vaccines, were not reported. The pharmacist reported that the patient was over 65 years of age when he received all of these doses.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II as prophylaxis (Strength, dose, route, lot # and expiration date were not reported), which experienced a temperature excursion of 22 Fahrenheit degrees for an unspecified timeframe. It was unknown if there were previous temperature excursions. Data logger was not involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA000721: US-009507513-1707USA000722: US-009507513-1707USA000723: US-009507513-1707USA000724.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On 13-JUN-2017, the patient was vaccinated with VARIVAX (lot # M027347 with expiration date 01-JUN-2018; concentration, dose and frequency were unknown) subcutaneously for prophylaxis. The medical assistant reported that the physician ordered varicella zoster vaccine and wanted the patient to receive ZOSTAVAX. Medical assistant reported that no attempt was made to clarify which vaccine the physician wanted patient to receive. No adverse effect was reported. No product quality complaint (PQC) was involved in this case.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received from a registered nurse, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with PROQUAD (lot # M044020 with expiration date 01-MAY-2018; concentration, dose, route and frequency were unknown) for prophylaxis, instead of M-M-R II. The nurse stated that the pharmacy had given them the wrong box of medication. No adverse effects were reported. No product quality complaint (PQC) was involved in this case.
Sex: M
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: This spontaneous report was received from a consumer referring to his son, a patient of unknown age. Information about concurrent condition, medical history and historical medication was unknown. On an unknown date in June 2017 (reported as a year ago), the patient was administered the first dose of GARDASIL (lot #, expiration date, dose and frequency unknown) intramuscularly for prophylaxis. On an unknown date, the patient did complete the dosing series (inappropriate schedule of vaccine administered). The reporter would contact the physician to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, medical history and historical medication was unknown. On an unknown date in June 2015 (reported as 2 years ago), the patient received ZOSTAVAX (unknown lot number and expiration date) reconstituted with sterile water diluent (unknown lot number and expiration date) at an unspecified pharmacy. On 16-JUN-2017, the patient was administered a second dose of ZOSTAVAX (19400 plaque-forming unit (PFU), lot # M037655, expiration date 29-NOV-2017, dose route and frequency unknown) for prophylaxis. Diluent lot L008523, expiration date 26-NOV-2017. No adverse effect was reported.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were unspecified. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 lot # L036301, expiration date: 20-DEC-2017 (dose, route of administration and anatomical location were not reported). The vaccine was stored in temperature between 9 to 25 degrees Celsius for 3 hours and 30 minutes. It also underwent previous temperature excursion (9 to 25 degrees Celsius) for 2 hours and 20 minutes. Digital data logger was used to detect temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000768: US-009507513-1707USA000770: US-009507513-1707USA000767: US-009507513-1707USA000769: US-009507513-1707USA000794.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 15-JUN-2017, the patient was vaccinated with GARDASIL lot # K007828 for prophylaxis. On 15-JUN-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to GARDASIL. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 54 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 16-JUN-2017, the patient was vaccinated subcutaneously with an expired dose of M-M-R II injection (lot # K009956, expiration date: 14-JUL-2016; therapy type, exact dose were not reported). Concomitant therapy included properly stored MERCK STERILE DILUENT. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse and refers to two patients of unknown age and gender. No information regarding the patients' pertinent medical history or concurrent conditions was reported. On an unknown date(s), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot reported as M000326, expiration date: 14-OCT-2019; dose and route of administration were not reported). The vaccine was stored in temperature of 47 degrees Fahrenheit for 42 minutes. It also underwent previous temperature excursion (47 degrees Fahrenheit) for 33 hours. Digital data logger was used to detect the temperature excursion. No product quality complaint (PQC) was involved. Lot number M000326 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blood test, Musculoskeletal chest pain, Rash
Clinical narrative: This spontaneous report has been received from a 74 year old female patient, who was reporting on herself. The patient's concurrent condition included cancer. The patient had concomitant medications but did not want to disclose the names of medication. No information regarding the patient's pertinent medical history and drug reactions or allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX 1 time injected vaccine (dose, route of administration, lot # and expiration date were not reported). On unknown dates, reported as for the last couple of years, the patient got pain in her back and sometimes in her rib cage. On unknown dates, she had two rashes in her back for a couple of months. The lab diagnostic studies included blood work on an unknown date (no results provided). The patient did not seek medical attention. No product quality complaint was involved. The outcome of the event was not reported. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected because there was no consent to contact the patient's physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and refers to 2 unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 15-JUN-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M031568, expiration date 24-DEC-2017 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) lot # reported as L029075, expiration date 28-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 15 and 46 degrees Fahrenheit for 2 hours and 30 minutes. Digital data logger was involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare provider and refers to an adult patient of unknown age (reported as over 18-year-old) and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 01-JUN-2017, the patient was vaccinated with VAQTA (route of administration reported as injection, dose and frequency were not provided, lot # M034893, expiration date: 26-MAY-2017). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and 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 19-JUN-2017 (reported as "today"), the patient was vaccinated with expired dose of GARDASIL lot # M014929, expiration date 27-MAY-2017 (dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV9, MMR, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. The registered nurse reported that on an unknown date, the patient may had received one of improperly stored lots. It was reported that she was not sure which of the vaccines the unspecified patient received. This was the possible vaccines involved: PEDVAXHIB lot # M001814, expiration date: 15-OCT-2018 (dose, frequency, route and anatomical location were not reported), GARDASIL 9, M036059, expiration date: 03-JUN-2019 (dose, frequency, route and anatomical location were not reported), ROTATEQ, M006111, expiration date: 18-NOV-2017 (dose, frequency, route and anatomical location were not reported) and M-M-R II, M000768, expiration date: 05-JAN-2018 (dose, frequency, route and anatomical location were not reported)  for prophylaxis. There was no adverse effect reported. Data logger was involved. There were no previous excursions reported. Administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1hour/ 30minutes. There was no product quality complaint (PQC) involved.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist concerning of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date the patients were vaccinated with ZOSTAVAX lot # M041085, expiration date: 03-JAN-2018 and lot#: M041510, expiration date: 27-JUL-2017 (dose, frequency, route and anatomical location were not reported) for prophylaxis. There was no adverse effect reported. There was no adverse effect reported in any patients. Data logger was involved. There were no previous excursions reported. Administered dose of vaccine experienced the temperature excursion of 15.3 degrees Fahrenheit for 1 hour 15 minutes  and 13 degrees Fahrenheit for 8 hour/ 45minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA000696.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a multiple unspecified patients of unknown gender and age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (strength, dose, frequency, route of administration were not provided), lots # M031941 with expiration date of 27-DEC-2017;  M033209 with expiration date of 09-JAN-2018;  M037009 with expiration date of 21-FEB-2018; M015695 with expiration date of 26-SEP-2017; M040142 with expiration date of 27-MAR-2018 and N004631 with expiration date of 07-AUG-2018 for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit (25.8 degrees Fahrenheit) for 60 minutes. Lots # M031941, M033209, M037009, M015695 experienced previous temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit (32.5 degrees Fahrenheit) for 5 hours, 50 minutes; 15 degrees Fahrenheit to 46 degrees Fahrenheit (40.2 degrees Fahrenheit) for 3 hours, 30 minutes and total time in the range 15 degrees Fahrenheit to 46 degrees Fahrenheit (40.6 degrees Fahrenheit) for 3 hours, 10 minutes. Lots # M040142 and N004631 experienced previous temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit  (40.6 degrees Fahrenheit) for 3 hours, 10 minutes. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA000708: US-009507513-1707USA000709.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 22-MAY-2017, the patient was vaccinated with a dose of VARIVAX (anatomical route of vaccination was not provided) for prophylaxis. On the same date, the patient was inadvertently administered with a dose of PROQUAD lot # M014301 (anatomical route of vaccination not provided) (accidental overdose). The vaccines were reconstituted with sterile diluent. It was reported that no adverse effects occurred and that no product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, refers to a patient of unknown age and gender. On an unspecified date the patient was given the first dose of the HPV series on an unspecified date with GARDASIL. Physician reports that patient received the second dose of the HPV series on an unspecified date "11 months later", with GARDASIL 9. No adverse effect was reported.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 54 year-old female. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, frequency and route of administration were not reported) lot # N009167 with expiration date of 02-FEB--2018, for prophylaxis. The temperature excursion of the ZOSTAVAX was of 41°F for a time frame of 8 hours. No previous temperature excursion occurred. Data logger was involved. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA000712.