chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 17 year-old female patient. There were no concurrent conditions, drug reactions or allergies reported for the patient. She did not have any medical history and her concomitant therapies included unspecified vitamins. On 19-MAR-2001 and 02-APR-2007, the patient was vaccinated with the first and second dose of VARIVAX (dose, frequency, route, lot # and expiration date were not reported), for prophylaxis. On an unspecified date in 2017 (reported as "last week"), the patient developed shingles like rash on her arm (rash vesicular), so, she was seen on the medical assistance's office on 29-MAR-2017 and was prescribed valacyclovir (VALTREX) as treatment and no laboratories were done. At the time of the report the patient was recovering from the adverse event. No product quality complaint (PQC) was involved. The causality between the adverse event and VARIVAX was unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Headache, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: This spontaneous report has been received from a Pharmacist, concerning a 75 year old female patient. The reporter stated the patient had a drug reaction/allergic to penicillin. She did not have medical history or any concurrent condition. It was unknown by the reporter if the patient was taking concomitant medications. On 29-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX23, intramuscular (dose, frequency, site of injection, lot # and expiration date were unknown), for prophylaxis. On 02-APR-2017, the patient experienced, swelling and soreness at the injection site, "hot" left arm (feeling hot), headache and joint pain. Following the administration of PNEUMOVAX 23. She sought medical attention by calling the pharmacist and unspecified treatment was given for the adverse events. There were none laboratories performed. The outcome of swelling and soreness at the injection site, localized feeling hot, headache and joint pain was reported as resolved on an unknown date in April 2017. The causal relationship between PNEUMOVAX23 and the events was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report was received from a medical assistant concerning a female patient of approximately 10 years old.     The patient did not have concurrent conditions, medical history or concomitant medication. The patient had a drug reaction or allergy to amoxicillin. In 2016 (on an unspecified time last year), the patient was vaccinated with the first dose of GARDASIL 9 as prophylaxis (dose, route of administration, lot number and expiration date were not reported). Shortly after vaccination, the patient developed tenderness, hardness, redness and itching at the injection site; the reporter also noticed the injection site. The patient's parents contacted the site where the vaccine was administered and they were advised (by an unspecified staff) to apply ice on the location. When the patient went to the office, to inform the response to the first dose, an unspecified provider called the symptoms as an allergic reaction. The patient received treatment for the events. The second dose of GARDASIL 9 was not administered. At the time of the report, the patient was "doing good". No further information was provided. The outcome of vaccination site pain, hypersensitivity, vaccination site pruritus, vaccination site erythema and vaccination site induration was not reported, neither was the causal relationship between the event and vaccine. Additional information has been requested.
Sex: F
Vaccine: BCG, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 50-year-old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication or drug reaction/allergy. On approximately 23-MAR-2017 (two weeks ago), the patient was vaccinated with bcg live (BCG VACCINE USP) intramuscular as prophylaxis (dose, lot number, and expiration date were not reported). On 05-APR-2017, the patient was vaccinated with VARIVAX as prophylaxis (dose, route of administration, lot number and expiration date were not reported). The patient did not seek medical attention and no adverse event was reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Information was received on 07-APR-2017 from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 06-APR-2017 the patient was vaccinated with ZOSTAVAX (lot number and expiration not reported), subcutaneous for prophylaxis in the hip instead of the arm. The patient had no adverse effects. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received on 07-APR-2017 from an other health professional via a company representative regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date the patient was vaccinated with a fourth dose of GARDASIL 9, (lot number and expiration not reported) intramuscular for prophylaxis which is other than indicated in the prescribing information. No adverse event reported. No further information was provided. 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 medical assistant and refers to an unspecified number of patients of unknown age and gender. No concomitant medications, medical history, drug reactions or allergies were reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (dose and route of administration were not reported, lot # M041079 with expiration date of 06-OCT-2018 and lot reported as M00996 with the expiration date of 07-JAN-2018) for prophylaxis. The vaccines were stored at temperature of 11.7 Fahrenheit degrees for 63 hours. Previous temperature excursion was also reported (storage at temperature of 6 to 14 Fahrenheit degrees for 13 hours). Temperature excursion was detected by digital data logger. No adverse effects were reported. Lot number M00996 is an invalid lot number for varicella virus vaccine live (oka/merck).  This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA009126:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a physician referring to a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. In February 2015, the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, lot #, expiration date or anatomical location were not reported) for prophylaxis. Then in February 2016 (reported as 1 year later), the patient received his second dose of GARDASIL 9 (strength, dose, route, lot #, expiration date or anatomical location were not reported) for prophylaxis. No adverse effect was reported and no additional information was provided. 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 pharmacist, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 10-APR-2017, the patient was subcutaneously vaccinated with an improperly stored dose of ZOSTAVAX vial 19400 DF reported as plaque forming unit (PFU) (dose and frequency were not reported) lot # M038864 with expiration date of 12-DEC-2017, for prophylaxis. The diluent MRK, lot # M042852 with expiration date of 30-MAY-2019, used to reconstitute the ZOSTAVAX was properly stored.  The temperature excursion of the ZOSTAVAX was 9.5 °F, the temperature excursion time frame was for 12 hours. No previous temperature excursion occurred. No adverse effects were reported. Data logger was involved. There was no product qualitycomplaint (PQC) involved. This is one of two reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA012146:
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received on 12-APR-2017 from a medical assistant regarding a 7 month old female patient. Medical history, concurrent conditions and concomitant medications were not reported. On 18-NOV-2016 the patient received her first dose of ROTATEQ (lot # M007125, expiration date 06-OCT-2017) (dose not specified) at the age of 7 months (considered inappropriate age at vaccine administration). No additional doses have been administered (considered missed doses). No adverse effects were reported. The action taken was not applicable and the outcome was not reported. The causal relationship was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown demographics. No information regarding patients' concurrent conditions, medical history and concomitant therapies was reported. From 17-FEB-2017 to 12-APR-2017, those patients received improperly stored doses of VARIVAX (doses and route of administration were not provided) lot # M039317, expiration date: 20-SEP-2018. Properly stored sterile diluent (STERILE DILUENT) (lot# and expiration date were not provided) was used for reconstitution of the vaccine. The time frames for temperature excursion were as follows: -14 degrees Celsius (C) to - 10 degrees C, for 38 minutes. The temperature excursion was detected by "data logger". There were no previous temperature excursions. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-APR-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # L012480, expiration date: 10-APR-2017, dose and route of administration were not reported) reconstituted with sterile diluent (MRK) (lot #L012345, expiration date: 23-JAN-2018). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA006401:
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-APR-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # L012480, expiration date: 10-APR-2017, dose and route of administration were not reported) reconstituted with sterile diluent (MRK) (lot # L012345, expiration date: 23-JAN-2018). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA006395:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered, Syringe issue
Clinical narrative: Information has been received from a licensed practical nurse and a medical assistant concerning a 4 year old female patient. The patient had no relevant medical history, drug history, concomitant medications or laboratory data. On 14-APR-2017 the patient was vaccinated with PROQUAD (dose unknown, lot# M044018, expiration date 01-MAR-2018, rHA) subcutaneously to vaccinate against measles, mumps, rubella and varicella virus and sterile diluent(manufacturer unknown) (strength and dose unknown, once, lot# M029234, expiration date 12-MAR-2017) subcutaneously for prophylaxis (expired product administered). On 14-APR-2017, a certified medical assistant was attempting to give a vaccination to the patient. However, the needle separated from the syringe. Because of this, the reporter did not believe that the patient received much of the vaccination, but could not confirm that the patient received no medication. The patient was then given a successful vaccination of the PROQUAD from the same lot and expiration date (incorrect dose administered). It was unknown if the patient received more than the recommended dose of PROQUAD, but so far no issues had been reported. As of 14-APR-2017 it was unknown if the patient would receive future doses of PROQUAD, and the outcome of possibly receiving more than the recommended dose was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 14-APR-2017, the patient was vaccinated with an expired dose of PROQUAD rHA (lot# L031600 and expiration date: 18-FEB-2017) (dose, route of administration, and anatomical location were not provided) for prophylaxis. No adverse effect was reported. No product quality complaint (PQC) was involved. The outcome of the reported event was not reported. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: This spontaneous report has been received from a consumer regarding his/her father, a 53 year old white patient.There was no information about the patient's concurrent conditions, medical history, any known allergies, reactions or concomitant medications. On 12-APR-2017, the patient was vaccinated with ZOSTAVAX 19400 "PFU", injected into triceps not deltoid due to clothing in the way and injected sub-cutaneous and not intramuscular due to injection into tricep, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). After the vaccination, the patient experienced vaccination site erythema with red, swollen and painful rash. The injection site reaction began to spread across back of arm. Subsequently, the patient who is physician self-prescribed prednisone 20 mg x 5 days starting on 14-APR-2017. The outcome of the events was unknown as well as the causal relationship between the events and the ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to 4 patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patients were vaccinated with PNEUMOVAX23 via intramuscular route (dose, lot number and expiration date were not reported). On an unknown date, the patients returned to the office complaining of severe pain and swelling at the injection site. There was no product quality complaint involved in this case. The outcome of the events and the relatedness between the events and the vaccine were not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 29 year old female patient. The patient's concurrent conditions, medical history or concomitant medications were not reported. On an unspecified date in September 2016 and on an unspecified date in October 2016, the patient received the first and the second dose of GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were not reported) both doses for prophylaxis. On 19-APR-2017, the patient was vaccinated with GARDASIL with lot # M014929 and an expiration date of 27-MAY-2017 (strength, dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. 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 registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of GARDASIL 9 (dose, route, lot # and expiration date were not reported) for prophylaxis. The vaccines were reconstituted whit a properly stored sterile diluent (DILUENT MRK) (lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 56 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA015113: US-009507513-1704USA015115: US-009507513-1704USA015112: US-009507513-1704USA015114.
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's concurrent condition included allergy to neomycin. No information regarding the patient's pertinent medical history and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) to prevent shingles. On an unknown date, approximately one week after vaccination, the patient experienced dizziness and "feeling of being off balance". The reporter stated that the patient saw a physician who prescribed an unknown medication to treat dizziness. The outcome of the events was reported as not recovered. The causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to the multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported.     On an unknown dates, the unspecified multiple patients were vaccinated with a dose of RECOMBIVAX HB lot number: M037248, expiration date: 21-FEB-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 to 35 degrees Fahrenheit (35.2 degrees Fahrenheit) for 1 hour and 50 minutes. The previous temperature excursion was reported as 32 to 35 degrees Fahrenheit (35.4 degrees Fahrenheit) for 55 minutes and 47 to 77 degrees Fahrenheit (48.2 degrees Fahrenheit) for 40 minutes. Data logger was involved. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA015098: US-009507513-1704USA015099:
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacy student referring to a currently 75 years old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unspecified date in 2015, the patient received the first dose of RECOMBIVAX HB (strength, dose, route, lot #, expiration date and anatomical location were not reported) for prophylaxis. Later, on an unspecified date in 2016, the patient received the second dose of RECOMBIVAX HB (strength, dose, route, lot #, expiration date and anatomical location were not reported) for prophylaxis. Subsequently on 21-APR-2017, the patient presented to the office to receive the third dose RECOMBIVAX HB. No adverse effects were reported and no further information was not provided. Additional information is not expected since the reporter refused to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 10-APR-2017, the patient was subcutaneously vaccinated with an improperly stored dose of ZOSTAVAX vial 19400 DF reported as plaque forming unit (PFU) (dose and frequency were not reported) lot # M038864 with expiration date of 12-DEC-2017, for prophylaxis. The diluent MRK, lot # M042852 with expiration date of 30-MAY-2019, used to reconstitute the ZOSTAVAX was properly stored.  The temperature excursion of the ZOSTAVAX was 9.5 °F, the temperature excursion time frame was for 12 hours. No previous temperature excursion occurred. No adverse effects were reported. Data logger was involved. There was no product quality complaint (PQC) involved. This is one of two reports received from the same source. Additional information has been requested; Sender's Comments: US-009507513-1704USA005234:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Deafness bilateral, Erythema
Clinical narrative: This spontaneous report was received from a 58 year old female patient, who was reporting on herself. The patient's medical history included: celiac disease. The patient had a drug reactions or allergies to sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine (SULFA).  On 23-JAN-2017, the patient was vaccinated with one dose of ZOSTAVAX subcutaneously to prevent shingles (dose, site of administration, lot # and expiration date were not reported). Concomitant therapies included tetanus toxoid shot. On an unknown date in 2017 (reported as shortly after receiving ZOSTAVAX), the patient developed a big red dot on an unspecified arm. The red dot lasted on her arm for about a week. Approximately in the middle of February 2017, the patient lost her hearing. The patient sought medical attention by seeing an unspecified physician, who prescribed her an oral prednisone treat the event. The patient said that it helped but her hearing did not fully return. Then the unspecified physician injected two unspecified topical steroids into her ear drums. The patient stated that her hearing improved but she still could not hear as well as she did before she received ZOSTAVAX. Another physician stated to her that she had some form of hearing lost in both ears. On an unknown date in 2017, the patient had an unspecified hearing test performed, but the results were not reported. The outcome of hearing loss bilateral was reported as recovering. The outcome of big red dot on an unspecified arm was considered resolved, on an unknown date in 2017. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the event of hearing loss bilateral was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 24-APR-2017 from a female pharmacy technician, referring to one unspecified patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug allergies were not reported. The pharmacy technician reported that on an unspecified date, one unspecified patient was vaccinated with improperly stored ZOSTAVAX (Lot number M036296, expiration date 14-NOV-2017) reconstituted with properly stored DILUENT MRK (Lot number reported as L037795 (as reported), expiration date 04-MAY-2018) for prophylaxis. The Dose, strength, site of administration and route of administration of ZOSTAVAX was not reported. The ZOSTAVAX excursion information was reported as: exposed to temperature: "8.2 F" (8.2 degrees Fahrenheit) for a time frame of 1 hours 15 minutes. There was a previous temperature excursion reported (date not specified): "6F to 14" (6 degrees Fahrenheit to 14 degrees Fahrenheit) for 2 hours. The call was because of a "data logger." No adverse effect reported. There was no product quality complaint involved. No further information was provided. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA015287.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: This spontaneous report was received the patient's mother and refers to her 5 year old female daughter. There was no pertinent medical history, drug reactions or allergies nor concomitant therapies reported. On 21-APR-2017, the patient was vaccinated with PROQUAD (dose, route, lot number and expiration date were not reported), along with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (dose, route, lot number and expiration date were not reported) and poliovirus vaccine inactivated (unspecified) (dose, route, lot number and expiration date were not reported), all vaccines for prophylaxis.   On 22-APR-2017 (reported as the next morning), the patient wake up with fever of "103.4 (units not reported) and chills, and shaking". The patient's mother contacted the physician to verify the other injections administered to her daughter and to inform of her daughters symptoms. The reporter stated that the physician's staff only gave the information of the other injections, but did not recommended any treatment for her daughter symptoms. The mother stated that on 23-APR-2017 (at the next morning), the patient was a lot better. The outcome of the events was reported as recovering. No labs diagnostics studied were performed.  The causal relationship between the events and the suspect therapies PROQUAD, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and poliovirus vaccine inactivated (unspecified) was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a administrator and refers to a currently 21 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In October 2013, the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiration date were not reported) and on 10-APR-2014, the patient was vaccinated with the second dose of GARDASIL (dose, route, lot number and expiration date were not reported), both for prophylaxis. At the time of reporting, the patient had not received the third dose of GARDASIL (schedule of drug administration). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 25-APR-2017, the patient was vaccinated with expired dose of ROTATEQ lot # L020865, expiration 09-FEB-2017.  The ROTATEQ did not have previous temperature excursions. No adverse events reported. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's past medical history, concurrent condition, or concomitant medication.The patient was vaccinated with RECOMBIVAX HB (lot number, dosage, and route of administration not provided) and PEDIARIX (GlaxoSmithKline) (lot number, dosage, and route of administration not provided) at the same time on the same unspecified day. No adverse symptoms reported. No further information was provided. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a pharmacist concerning a female patient of unknown age, with no pertinent medical history, no allergies, and no concomitant medication. On an unknown date "about 20 years ago," the patient was vaccinated with 3 doses of RECOMBIVAX HB (lot numbers, dosages, and routes of administration not provided). A blood test was performed (exact results and date not reported). The pharmacist stated that the patient subsequently has low titers for hepatitis B (onset not provided). No treatment was given. The outcome of the event is unknown. No further information was provided.       Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to the multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On an unknown dates, the unspecified multiple patients were vaccinated with a dose of VAQTA lot number: M039202, expiration date: 11-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 to 35 degrees Fahrenheit (35.2 degrees Fahrenheit) for 1 hour and 50 minutes. The previous temperature excursion was reported as 32 to 35 degrees Fahrenheit (35.4 degrees Fahrenheit) for 55 minutes and 47 to 77 degrees Fahrenheit (48.2 degrees Fahrenheit) for 40 minutes. Data logger was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA015099: US-009507513-1704USA011714.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to the multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported.     On an unknown dates, the unspecified multiple patients were vaccinated with a dose of ROTATEQ lot number: M038744, expiration date: 26-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 to 35 degrees Fahrenheit (35.2 degrees Fahrenheit) for 1 hour and 50 minutes. The previous temperature excursion was reported as 32 to 35 degrees Fahrenheit (35.4 degrees Fahrenheit) for 55 minutes and 47 to 77 degrees Fahrenheit (48.2 degrees Fahrenheit) for 40 minutes. Data logger was involved. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA011714: US-009507513-1704USA015098:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, or drug allergies were not reported. On unspecified dates, patients were vaccinated with improperly stored doses of PROQUAD injection (dose and route of administration were not reported) lot number M042501, expiration date 17-APR-2018, for prophylaxis. According to the reporter, PROQUAD doses were exposed to the following temperature excursions: between -9 degrees Celsius (C) and 8C for an undetermined time frame. Previous temperature excursion was -9.5C  for 1 hour and 6 minutes. The suspect vaccine was reconstituted with sterile diluent (manufacturer unknown) (lot number and expiration date were not reported). No adverse effects were reported. A digital data logger was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 24-APR-2017 from a female pharmacy technician, referring to one unspecified patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug allergies were not reported. The pharmacy technician reported that on 21-APR-2017, an unspecified patient was vaccinated with improperly stored ZOSTAVAX (Lot number M036296, expiration date 14-NOV-2017) reconstituted with properly stored DILUENT MRK (Lot number reported as L032214 (as reported), expiration date 13-APR-2018) for prophylaxis. The Dose, strength, site of administration and route of administration of ZOSTAVAX was not reported. The ZOSTAVAX excursion information was reported as: exposed to temperature: 8.2 F (8.2 degrees Fahrenheit) for a time frame of 1 hours 15 minutes. There was a previous temperature excursion reported (date not specified): 6F to 14F (6 degrees Fahrenheit to 14 degrees Fahrenheit) for 2 hours. The call was because of a data logger. No adverse effect reported. There was no product quality complaint involved. No further information was provided. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA012523.
Age: 1.5
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II lot # L036853, expiration date: 24-SEP-2017 (Strength, dose, frequency and route were not reported) as prophylaxis, which experienced a temperature excursion of 9 Celsius degrees for 20 hours. Previous temperature excursions were reported as from 02-OCT-2016 to 04-OCT-2016 of 9 Celsius degrees for 43 hours 30 minutes. From 25-OCT-2016 to 26-OCT-2016 of 9 Celsius degrees for 23 hours and 30 minutes. On 28-OCT-2016 of 9 Celsius degrees for 48 hours. From 23-DEC-2016 to 24-DEC-2016 of 9 Celsius degrees for 20 hours. Data logger was not involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001013:
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Gastroenteritis viral, Injection site discolouration, Injection site erythema, Vomiting
Clinical narrative: Large red and purple oval around shot hole of the shot. This grew seen throughout the day and spread larger. Then I tried BENADRYL and ice on and off. Three hours past, it did nothing. Have her a warm shower. This made it look much worse. The next two days after that she couldn't keep food or drinks down with extreme vomiting. Now that it's Monday, I've tried her pediatrician. Phones weren't responding so I walked in with her. They looked at her from across a dark hallway. No examining. They said she has a stomach bug on top of the reasons from the shot. They also went against what their own paperwork says by saying that there bailed do not cause vomiting or fevers.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness with firmness and heat to touch at the sight (left arm).
Age: 38.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Hepatomegaly, Laboratory test abnormal
Clinical narrative: Patient claims that labs studies show an hepatomegaly and claims it was from the vaccines we administered to him.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction, Erythema
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to six patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated by th epharmacist with PNEUMOVAX23 intramuscularly (dose, anatomical location, lot# and expiration date were not reported) for prevention of pneumococcal disease. On unknown dates, the patients experienced an adverse reaction. Each patient developed an extremely red arm. The patients sought for medical attention. On unknown dates, the patients recovered from the event. The relatedness between the event of extremely red arm and the PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia
Clinical narrative: This spontaneous report has been received from a pharmacy intern referring to a 50-year-old female patient. The patient's relevant concurrent conditions included coronary artery disease, asthma, arthritis, and a drug reaction/allergy to sulfa drugs. The patient did not have any concomitant therapies and her historical conditions were not reported. On 14-APR-2017, the patient was vaccinated with a dose of ZOSTAVAX (lot # M041510, expiration date 27-JUL-2017; dose, route of administration, and frequency were not reported) to prevent shingles which was reconstituted with a sterile water diluent (manufacturer unknown) (lot number and expiration date was not reported). On 18-APR-2017, the patient developed facial numbness. Subsequently, on an unknown date in April 2017, the patient developed shingles (Herpes zoster) that was confirmed by an unknown method. At the time of this report, the patient had not recovered from hypoaesthesia and the outcome of Herpes zoster was unknown. The varicella Zoster virus identification program (VZVIP) packet was sent. The causality assessment between hypoaesthesia and Herpes zoster with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with ZOSTAVAX (strength, dose, route, lot #, expiration date or anatomical location were not reported) for prophylaxis. The reporter stated that she had seen on facebook and online that other reporter was discussing the dangers of shingles outbreaks after the vaccination of unspecified patients with ZOSTAVAX. The pharmacist stated that she began seeing posts on facebook about this between March and April 2017 (reported as the last couple of weeks). There was no further information to report. The outcome of the shingles and the unspecified adverse event (reported as dangers) was unknown.  The causal relationship between the events and the suspect therapy was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On unspecified dates, patients were vaccinated with improperly-stored doses of ROTATEQ oral liquid, (strength and dose were not reported) administered orally (lot # L042214, expiration date 14-JUN-2017/ lot # M019708, expiration date 25-OCT-2017) for prophylaxis. According to the reporter, ROTATEQ doses were exposed to the following temperature excursions: 51 hours between 32 degrees Fahrenheit (F) and 35F, and for 14 hours and 15 minutes between 47F and 77F (60F). No adverse effects were reported. A digital data logger was involved. This is one of several reports from the same reporter. Additional information is not expected as the reporter refused additional contact.; Sender's Comments: US-009507513-1705USA000387:  US-009507513-1705USA000339:
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: After 5 minutes from vaccine administration, patient developed localized rash to left thigh at site of injection. Benadryl was given. Patient was observed for another 15-20 minutes, was released to mom's care with rash resolving.
Age: 84.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site mass, Pain in extremity
Clinical narrative: Patient reported to pharmacy approximately 1 year after receiving vaccination to inquire about whether adverse events that he had been experiencing were normal. Patient complained of arm pain ever since receiving the vaccination that has failed to improve fully over time. Still limits his ability to use that arm for recreational and daily activities. He also complains of a lump at the injection site.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: BACK OF ARM PAINFUL WHICH WAS FOLLOWED THE NEXT DAY BY SYMPTOMS OF REDNESS AND HOT.  NO ICE OR MEDICATION WAS UTILIZED TO TREAT THE SIDE EFFECTS.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis on left thigh.  Treating with Cephalexin x 7 days.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Gait disturbance, Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 4/28/17  Communication: Mom reports left leg is red and swollen w/pain from the buttock to the ankle. He had a DTaP vaccine in the left thigh on Wed 4/26/17. Mom unsure if he has a fever as she doesn't have a thermometer at home. Transferred to scheduling to set up appt for today. 4/28/17 Office visit: History of present illness: The patient presents for rash. The symptom(s) are described as moderate and worse. Affected area(s) include right thigh. Relevant history positive for family history of dermatitis.  Mom reports yesterday area around injection site was red, she spoke with nurse and was told to place ice on area which she did. Today she reports redness and swelling from tight buttock to ankle, child has been limping. Physical Exam: Skin:  Right thigh with edema from hip to knee, erythematous, warm to touch. Assessment/Plan:  Cellulitis of right thigh. Take all of antibiotic that is prescribed, can give Tylenol if child is painful. If swelling or redness continue to spread after being on antibiotic return to office or take child to the ER. 5/1/17 @ 2:14  I called mom and she said redness is gone, some tenderness, walking on leg fine.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: 4/28/17  Communication: Mom reports left leg is red and swollen w/pain from the buttock to the ankle. He had a DTaP vaccine in the left thigh on Wed 4/26/17. Mom unsure if he has a fever as she doesn't have a thermometer at home. Transferred to scheduling to set up appt for today. 4/28/17 Office visit: History of present illness: The patient presents for rash. The symptom(s) are described as moderate and worse. Affected area(s) include right thigh. Relevant history positive for family history of dermatitis.  Mom reports yesterday area around injection site was red, she spoke with nurse and was told to place ice on area which she did. Today she reports redness and swelling from tight buttock to ankle, child has been limping. Physical Exam: Skin:  Right thigh with edema from hip to knee, erythematous, warm to touch. Assessment/Plan:  Cellulitis of right thigh. Take all of antibiotic that is prescribed, can give Tylenol if child is painful. If swelling or redness continue to spread after being on antibiotic return to office or take child to the ER. 5/1/17 @ 2:14  I called mom and she said redness is gone, some tenderness, walking on leg fine.
Sex: U
Vaccine: MMR
Symptoms: Drug dose omission, No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies. On an unknown date, the patient was going to be vaccinated with the second dose M-M-R II, subcutaneously (lot number L046506 and expiration date 17-MAY-2017) for prophylaxis (dose was not reported). However, the patient missed the dose because the product was found unfit for use and needed replacement. A product quality complaint was done. No adverse event was reported and no further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 25-APR-2017 from a licensed practical nurse who reported that unspecified patient was administered subcutaneously an expiry dose of M-M-R II (lot # M032153, expiration 22-APR-2017) on 25-APR-2017. Medical history, concurrent conditions and concomitant medications were not reported. No adverse effects were reported. No further information was provided. The action taken was not applicable and the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 25-APR-2017 from a nurse practitioner regarding multiple unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (lot # unknown) (dose not specified). No adverse effects were reported. The action taken was not applicable and the outcome was unknown. Excursion information: Vaccine involved: RECOMBIVAX HB Temperature: 33.0 degrees Fahrenheit Time Frame: 40 minutes. Previous temperature excursion? Yes, 34.8 degrees Fahrenheit for 21 minutes. Was call because of a "data logger"? Yes. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 24-APR-2017, the patient was vaccinated with the fourth dose of GARDASIL, lot number M040412 with expiration date 30-JUN-2019, (dose, route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.