chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (also reported as Licensed Practical Nurse) and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On 08-DEC-3025, the patient received the first dose of M-M-R II (lot # L010488, expiration date: 26-MAR-2017, dose, route of administration and injection site were not reported) and the first dose of VARIVAX (Merck) (lot# L02121, expiration date: 10-JUN-2017, dose, route of administration and injection site were not reported). The patient received a second dose of M-M-R II (lot # L015282, expiration date: 30-APR-2017, dose, route of administration and injection site were not reported) and a second dose of VARIVAX (Merck) (lot # L033138, expiration date: 31-AUG-2017, dose, route of administration and injection site were not reported), on 02-FEB-2016, which was too short of an interval. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates in 2016 ("between 09-FEB-2016 and 03-MAR-2016"), the patients were vaccinated with doses of improper stored PROQUAD (Merck) (lot # L030591, expiration date 10-FEB-2017; lot # L032761, expiration date 24-FEB-2017) (dose and route were not reported). The vaccine was exposed to temperature 35F for 15 hours and 45 minutes. There was no previous temperature. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Antibody test negative, Viral titre
Clinical narrative: This spontaneous report as received from a physician refers to a 50 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown dates, the patient was vaccinated with 3 doses of VARIVAX (Merck) and with one dose of ZOSTAVAX (lot numbers and expiration dates were not provided). The patient received the doses due to having negative titers for varicella. On an unknown date after receiving the vaccinations, the patient did not seroconvert. The outcome of the event was not reported. The relatedness between the event and VARIVAX (Merck) and ZOSTAVAX was not reported. 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 Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX. No adverse event was reported. No concomitant medications were reported. The outcome of event was unknown. Temperature was maximum -3.5 C, time frame was no more than 1 hour every night (defrost cycling) and there was no Previous temperature excursion. Call was because of a data logger. MMR II appears in the Product List as it was involved in the excursion, however no improperly stored doses were administered. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Merck) (incorrect product storage). No adverse event was reported. No concomitant medications were reported. The outcome of event was unknown. Temperature was maximum -3.5 C, time frame was no more than 1 hour every night (defrost cycling) and there was no previous temperature excursion. Call was because of a data logger. M-M-R II appears in the Product List as it was involved in the excursion, however no improperly stored doses were administered. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Human papilloma virus test positive, Interchange of vaccine products, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a nurse and refers to a 25 year old female patient with "high-risk lifestyle". The patient had an unknown adverse reaction to ZITHROMAX in the past. On 18-SEP-2009, 16-NOV-2009 and 17-MAR-2010 the patient received, respectively, the first, the second and the third dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported). The patient's concomitant therapies include SPRINTEC 28. On 28-DEC-2015, the patient was administered a dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On 28-DEC-2015, the patient had a Pap test performed with an abnormal result. The Pap test detected human papillomavirus (HPV) High Risk HPV MRNA E6/E7. The patient sought medical attention via an office visit. On 29-FEB-2016, the patient received the fourth dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported). The outcome of abnormal pap smear result was reported as not recovered. The relatedness between the event and GARDASIL and GARDASIL 9 was not provided. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an approximately 12 month old female patient. The patient had no medical history, concurrent conditions, drug reactions/allergies and concomitant medications. On 22-FEB-2016, the patient was vaccinated with the first dose of M-M-R II Inj (lot# L013827 and expiry date 10-APR-2017) 0.5 ml, subcutaneously. On an unknown date in approximately February 2016, the patient experienced fever of 102 to 104 degrees and raised rash at the injection site which was hot. Patient sought medical attention-she returned to the office. Patient was treated with TYLENOL, MOTRIN and cold pack applied to the injection site. No lab diagnostics studies were performed. On 01-MAR-2016, the patient was doing better and had a slight fever. At the time of report, the outcome of events was reported to be recovering/resolving. Causality assessment was not provided. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586 with an expiration date of 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 17-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586 with an expiration date on 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On 06-NOV-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586 with an expiration date of 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. No medical history or concomitant medications were reported. On 02-MAR-2016, the patient was vaccinated via subcutaneous route with an expired dose of VARIVAX (Merck) (lot # K002915 and expiry: 26-FEB-2016). The patient experienced no adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 04-MAR-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K023624, expiration date 19-FEB-2016, exact dose and route of administration were not reported). No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot# L037561, expiry date 29-SEP-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The reporter stated that the vaccine was exposed to a temperature of 7.5 degrees Fahrenheit for a total period of 14 hours (date unspecified). There was no previous temperature excursion or product quality complaint involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) injection (lot# L046509, expiry date 17-MAY-2017, albumin status rHA; dose and route of administration were not reported). There were no concomitant therapies reported. The reporter stated that the vaccines were exposed to a temperature of 7.5 degrees Fahrenheit for a total period of 14 hours (date unspecified). There was no previous temperature excursion or product quality complaint involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX injection (lot# L037561, expiry date 29-SEP-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The reporter stated that the vaccines were exposed to a temperature of 7.5 degrees Fahrenheit for a total period of 14 hours (date unspecified). There was no previous temperature excursion or product quality complaint involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and health professional and refers to a 4 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and health professional and refers to a  year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On an unknown date on or after 02-NOV-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot # L019835 and expiry date: 23-MAR-2017) at an unknown dosage. Excursion details included: temperature 27 F and no previous temperature excursion, time frame was 6 weeks (42 days) and was because of data logger. No adverse effect reported. It was reported that the M-M-R II appears in the product list as it was involved in the excursion, however no improperly stored doses of M-M-R II were administered. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On unspecified dates in 2016 (reported as starting on or after 11-FEB-2016), the patients were vaccinated with improperly stored doses of MMR II (lot # K024035, expiration date 26-NOV-2016, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 46.8F for 2 hours. No previous temperature excursion was reported. No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unspecified dates in 2016 (reported as starting on or after 11-FEB-2016), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L030868, expiration date 09-JUN-2018, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 46.8F for 2 hours. No previous temperature excursion was reported. No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. 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 healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unspecified dates in 2016 (reported as starting on or after 11-FEB-2016), the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot # L027726, expiration date 01-MAY-2017, exact doses were not reported, orally). The vaccines were exposed to temperature of 46.8F for 2 hours. No previous temperature excursion was reported. No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse and refers to a male patient of unknown age. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date (reported as "a couple of weeks ago"), the patient as vaccinated with a dose of ZOSTAVAX 1 shot once, subcutaneously (lot # and expiration date were not reported). On an unknown date, the patient developed redness and swelling at the injection site. On approximately 24-FEB-2016 (reported as "about a week ago"), the patients redness and swelling went away. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 04-FEB-2015, the patient was vaccinated with PNEUMOVAX 23 lot # L014458, expiry date 16-FEB-2015, 0.5 ml given intramuscularly. On 08-MAR-2016, the patient received another dose of PNEUMOVAX 23 lot # L014458, expiry date 17-FEB-2017, 0.5 ml given intramuscularly for the same indication. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a physician assistant refers to a male patient who was 30 to 40 years old. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with M-M-R II, intramuscularly (dose, site of administration, lot # and expiry date were not reported). The vaccine was reconstituted with an unspecified amount of normal saline solution rather than the diluent that was supplied with the vaccine. The person who reconstituted the dose of M-M-R II used normal saline solution rather than the diluent supplied with the vaccine because the practice obtained it from another site, and the diluent was not sent with the lyophilized M-M-R II dose. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to four patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored doses RECOMIBVAX HB injection, lot # L027733, expiration date 30-APR-2017 (dose and route of administration were not reported). No adverse symptoms were reported. The vaccine was exposed to temperature 47.1 Fahrenheit (F) for 4 minutes with previous excursion 46.8 F for 1 hour and 45 minutes. This is one of several reports from the same source. Additional information has been requested.
Age: 0.99
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 month female patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 21-JAN-2016 at 11:39, the patient was vaccinated with the first dose of PEDVAXHIB lot # L030869, intramuscularly, in the right thigh (strength, dose and expiration date were not reported), which was improperly stored. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old female patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 20-JAN-2016 at 16:33, the patient was vaccinated with the first dose of GARDASIL intramuscularly in the right deltoid, lot number L016428 (strength, dose and expiration date were not reported), which was improperly stored. The reporter stated that no adverse events were documented per medical doctor. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 year old male patient. The patient's concurrent conditions included intractable headache for 5 months. The patient's other pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On 06-JAN-2016 at 18:19, the patient was vaccinated with the first dose of GARDASIL intramuscularly, lot number L019297 (strength, dose, site of administration and expiration date were not reported), which was improperly stored. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old male patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 06-JAN-2016 at 15:25, the patient was vaccinated with the first dose of GARDASIL lot # L016428, intramuscularly in the right deltoid (strength, dose and expiration date were not reported), which was improperly stored. The reporter stated that no adverse events were noted per medical doctor. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage, Major depression
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On 07-JAN-2016 at 10:22, the patient was vaccinated with the first dos of GARDASIL intramuscularly, in left deltoid, lot number L016428 (strength, dose and expiration date were not reported), which was improperly stored. On an unknown date in approximately 2016, the patient was diagnosed with major depressive disorder with single episode in full remission. The outcome of major depressive disorder with single episode in full remission was not reported. The relatedness between this event and GARDASIL was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: HPV4
Symptoms: Developmental delay, Drug administered to patient of inappropriate age, Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 month old male patient. The patient's medical history included prematurity. The patient's concurrent conditions and concomitant medication were not reported. On 15-JAN-2016 at 15:28, the patient was vaccinated with the first dose of GARDASIL intramuscularly in right thigh, lot number reported as L030869 (strength, dose and expiration date were not reported), which was improperly stored. Lot number L030869 has been verified to be an invalid lot number for GARDASIL. On an unknown date in approximately 2016, the patient was not reaching expected milestones even after adjusting for prematurity. The outcome of this event and the relatedness between this event and GARDASIL were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Aggression, Incorrect product storage, Myopia, Tonsillar hypertrophy
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 year old female patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 07-JAN-2016 at 11:12, the patient was vaccinated with a dose of improperly stored GARDASIL intramuscularly in the left deltoid, lot number L019297 (strength, dose, dose number and expiration date were not reported). On an unknown date in approximately 2016, the patient experienced tonsillar enlargement, temper tantrums and bilateral near sightedness. The outcome of tonsillar enlargement, temper tantrums and bilateral near sightedness was not reported. The relatedness between these events and GARDASIL was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old male patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 27-JAN-2016 at 16:47, the patient was vaccinated with the first dose of GARDASIL lot # L016528, intramuscularly in the right deltoid (strength, dose and expiration date were not reported), which was improperly stored. The reporter stated that no adverse events were noted per medical doctor. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified patients of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. The reporter stated that, the patients were vaccinated with improperly stored doses (temperature excursion: 48.7 F, time frame: 3 hours) of PNEUMOVAX 23 with lot/batch # L014420, expiry date 23-FEB-2017 (dose, dose number, vaccination site and route of administration not provided) since 02-FEB-2016. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified patients of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. The reporter stated that, the patients were vaccinated with improperly stored doses (temperature excursion: 48.7 F, time frame: 3 hours) of M-M-R II with lot # L013429, expiry date 21-JUL-2017 (dose, dose number, vaccination site and route of administration not provided) since 02-FEB-2016. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No medical history, concurrent conditions, drug reactions/ allergies and concomitant medications were reported. On 09-MAR-2016, the reporter vaccinated the patient with GARDASIL, 0.5 ml dosage, administered intramuscularly (dosage number, lot # and expiration date were not reported), even though the product in the vial did not appear as cloudy as it should be following agitation of the product. This was considered to be a product quality issue. However, no adverse effects were reported at the time of the report. Additional information is not expected since no consent for contact was provided.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Psoriasis
Clinical narrative: This spontaneous report was received from a 89 year old female patient with diabetes mellitus, hypertension and drug hypersensitivity. The patient's medial history included cerebrovascular accident. On an unspecified date in April 2015, the patient was vaccinated with ZOSTAVAX (dose, route and concentration were not provided). Concomitant therapies included glipizide, PLAVIX and losartan potassium (manufacturer unknown) and unspecified "water pills". Two days after receiving ZOSTAVAX, the patient experienced psoriasis all over her body. On an unspecified date the patient sought medical attention with an unspecified physician and a "skin biopsy" was taken which confirmed the reaction was psoriasis. The consumer stated that the physician has prescribed her numerous unspecified "creams" as treatment but "nothing has helped". There was no product quality complaint (PQC) reported. The outcome of psoriasis was reported as not recovered. 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 refers to a patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient's were vaccinated with improperly stored ROTATEQ lot # K023535 (expiry date: 22-MAY-2016) at an unknown dosage. The temperature of the vaccine was 33.8 F and time frame was 96 hours. There was no data logger. No adverse reactions were reported. No further information was provided. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Arm red, warm and sore at site.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and health professional and refers to a 4 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-NOV-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (rHA), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and health professional and refers to a 4 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and health professional and refers to a 4 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (rHA), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Nausea, Pain in extremity, Pyrexia, Rash
Clinical narrative: Patient returned to pharmacy approximately 24 hours after immunization complaining of fever, rash, malaise, N/V and sore arm.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Patient returned to pharmacy approximately 24 hours after immunization complaining of fever, rash, malaise, N/V and sore arm.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Itchy, redness.
Age: 55.0
Sex: F
Vaccine: FLU4, HEP, MMRV, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Administered MMRV instead of MMR due to human error.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) thigh red, warm to touch, swollen two days after vaccine given.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 09-FEB-2016 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose and route not reported, lot # L034372, expired date: 08-SEP-2016). The vaccine exposed to 6.9F for 34 minutes. No previous excursions. Concomitant therapy was not reported. No adverse effects. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist via a company representative referring to an unspecified number of unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with ZOSTAVAX (dose, frequency and route were not reported). On unknown dates the patients developed unspecified injection site reactions. These patients sought medical attention by visiting the pharmacist. Treatment including cold compress to the area and ibuprofen was given for the event. The outcome of the event was unknown. Causality was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth on left thigh.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, TDAP
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: 6cm x 4cm raised slightly red warm and painful.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Nodule, Swelling
Clinical narrative: Redness, swelling and lump 1.5 inches in diameter.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity, X-ray
Clinical narrative: The patient describes limitation of arm movement and pain in the arm the vaccine was administered.
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: Pt c/o painful left axilla 24 hours after immunization. Pain "moved" to upper arm, then stopped on 3/9/16.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 09-FEB-2016 the patient was vaccinated with improperly stored VARIVX (Merck) (dose and route not reported, lot # L034372, expired date: 08-SEP-2017). The vaccine exposed to 6.9F for 34 minutes. No previous excursions. Concomitant therapy was not reported. No adverse effects. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Headache, Injection site pain, Lymphadenopathy, Pyrexia
Clinical narrative: 02/23/2016 1st rabies vaccination given in left deltoid: NO REACTION. 03/01/2016 ~9:40am 2nd rabies vaccination given in left deltoid. 8:00pm pounding headache, chills, ear pressure, eyes felt like they were burning, increased RR and HR, temperature was 101.0. 8:20pm took Tylenol. ~10:20pm temperature 100.4 took Ibuprofen, temperature eventually went down to 98. Afterwards joints were throbbing, very achy, left arm very sore, lymph node in armpit was enlarged, pain radiated up my neck and down my chest. 7am felt very drained, in a daze like state. 9:00am went to Immunizations clinic, saw Doctor, left armpit remained sore/swollen for ~36 hours.
Age: 26.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Arthralgia, Axillary pain, Body temperature increased, Chest pain, Chills
Clinical narrative: 02/23/2016 1st rabies vaccination given in left deltoid: NO REACTION. 03/01/2016 ~9:40am 2nd rabies vaccination given in left deltoid. 8:00pm pounding headache, chills, ear pressure, eyes felt like they were burning, increased RR and HR, temperature was 101.0. 8:20pm took Tylenol. ~10:20pm temperature 100.4 took Ibuprofen, temperature eventually went down to 98. Afterwards joints were throbbing, very achy, left arm very sore, lymph node in armpit was enlarged, pain radiated up my neck and down my chest. 7am felt very drained, in a daze like state. 9:00am went to Immunizations clinic, saw Doctor, left armpit remained sore/swollen for ~36 hours.
Age: 26.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Ear discomfort, Eye irritation, Fatigue, Feeling abnormal, Headache
Clinical narrative: 02/23/2016 1st rabies vaccination given in left deltoid: NO REACTION. 03/01/2016 ~9:40am 2nd rabies vaccination given in left deltoid. 8:00pm pounding headache, chills, ear pressure, eyes felt like they were burning, increased RR and HR, temperature was 101.0. 8:20pm took Tylenol. ~10:20pm temperature 100.4 took Ibuprofen, temperature eventually went down to 98. Afterwards joints were throbbing, very achy, left arm very sore, lymph node in armpit was enlarged, pain radiated up my neck and down my chest. 7am felt very drained, in a daze like state. 9:00am went to Immunizations clinic, saw Doctor, left armpit remained sore/swollen for ~36 hours.
Age: 26.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Heart rate increased, Lymphadenopathy, Neck pain, Oedema peripheral, Pain in extremity
Clinical narrative: 02/23/2016 1st rabies vaccination given in left deltoid: NO REACTION. 03/01/2016 ~9:40am 2nd rabies vaccination given in left deltoid. 8:00pm pounding headache, chills, ear pressure, eyes felt like they were burning, increased RR and HR, temperature was 101.0. 8:20pm took Tylenol. ~10:20pm temperature 100.4 took Ibuprofen, temperature eventually went down to 98. Afterwards joints were throbbing, very achy, left arm very sore, lymph node in armpit was enlarged, pain radiated up my neck and down my chest. 7am felt very drained, in a daze like state. 9:00am went to Immunizations clinic, saw Doctor, left armpit remained sore/swollen for ~36 hours.
Age: 26.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Respiratory rate increased
Clinical narrative: 02/23/2016 1st rabies vaccination given in left deltoid: NO REACTION. 03/01/2016 ~9:40am 2nd rabies vaccination given in left deltoid. 8:00pm pounding headache, chills, ear pressure, eyes felt like they were burning, increased RR and HR, temperature was 101.0. 8:20pm took Tylenol. ~10:20pm temperature 100.4 took Ibuprofen, temperature eventually went down to 98. Afterwards joints were throbbing, very achy, left arm very sore, lymph node in armpit was enlarged, pain radiated up my neck and down my chest. 7am felt very drained, in a daze like state. 9:00am went to Immunizations clinic, saw Doctor, left armpit remained sore/swollen for ~36 hours.
Age: 24.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: This spontaneous report was received from a physician and refers to a 24 year old male patient with no drug reactions or allergies. The patient had gastrooesophageal reflux disease (GERD) and was at risk for human immunodeficiency virus (HIV) exposure. On 01-MAR-2016, the patient was vaccinated with a second dose in GARDASIL 9 lot #L045711, 0.5 ml, intramuscularly. Concomitant therapies included TUMS an NEXIUM. On 02-MAR-2016, the patient began to experience nausea, stomach aches and cramping. The patient began taking TRUVADA on 03-MAR-2016 and he was unable to eat and the symptoms worsened and persisted through 05-MAR-2016. No treatment for the events was given and no lab diagnostics studies were performed. On 09-MAR-2016, the patient came to the office for evaluation and stated that he was feeling better and that he still had some nausea but the cramping was gone. The outcome of cramping was recovered on an unknown date in March 2016. The outcome of other events was reported as recovering. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain upper, Feeding disorder, Muscle spasms, Nausea
Clinical narrative: This spontaneous report was received from a physician and refers to a 24 year old male patient with no drug reactions or allergies. The patient had gastrooesophageal reflux disease (GERD) and was at risk for human immunodeficiency virus (HIV) exposure. On 01-MAR-2016, the patient was vaccinated with a second dose in GARDASIL 9 lot #L045711, 0.5 ml, intramuscularly. Concomitant therapies included TUMS an NEXIUM. On 02-MAR-2016, the patient began to experience nausea, stomach aches and cramping. The patient began taking TRUVADA on 03-MAR-2016 and he was unable to eat and the symptoms worsened and persisted through 05-MAR-2016. No treatment for the events was given and no lab diagnostics studies were performed. On 09-MAR-2016, the patient came to the office for evaluation and stated that he was feeling better and that he still had some nausea but the cramping was gone. The outcome of cramping was recovered on an unknown date in March 2016. The outcome of other events was reported as recovering. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Reports pain after anthrax vaccination.  States that pain progressively worsened and area became pruritic, erythematous and swollen over the next 2 days.  Symptomatic treatment provided.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: Fever, (tested after ibuprofen = 100.5F), severe chills, flu like symptoms- muscle aches and joint pain. At injection site, red, hard, warm to touch about 5-6 cm.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Fever, (tested after ibuprofen = 100.5F), severe chills, flu like symptoms- muscle aches and joint pain. At injection site, red, hard, warm to touch about 5-6 cm.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Biopsy skin, Injection site erythema, Injection site pain
Clinical narrative: Pain and redness at injection site, worsening of pre-existing rash.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Diarrhoea, Pruritus, Tachycardia, Urticaria
Clinical narrative: Approx 1 hour after injection, had onset of diarrhea. On 3/8/16 developed itching. On 3/9/16 had diffuse hives. 3/10/16 continued to have hives, chills, and slight tachycardia. Had some treatment per family MD on 3/9/16, but on 3/10/16 went to ER. Was treated with Benadryl, Decadron, Zantac. Sent home with medications as well.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Headache, Influenza virus test negative, Pain, Pyrexia
Clinical narrative: Fever of 102, headache, body aches.
Age: 1.49
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Received Hep A on 2/20/16, broke out in a rash on 2/21/16. Mom gave low dose Benadryl with no improvement. Child was seen in the office on 2/22/16, no treatment recommendation at this time. Advised rash may be present 1-2 weeks and to return to the office if there is no improvement.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient called to report redness around the area of the injection.  It is not sore, itchy or bothersome.  She is not sure how long it has been there as she just noticed it today and immunization was a week ago.  I counseled the patient to keep and eye on the area and report back if the red area gets larger or bothersome to her.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt did not report any symptoms but received 2 Prevnar vaccines that was not indicated.
Age: 0.42
Sex: M
Vaccine: HIBV
Symptoms: Apnoea, Crying, Inappropriate schedule of drug administration, Injection site mass, Seizure
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) reporting on her son who is currently 2 years old. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The patient was administered a series of vaccines (unknown) including PEDVAXHIB on an unspecified dates in July, September and November 2013 (reported as at ages 2, 4 and 6 months respectively) (inappropriate schedule of vaccine administered). On an unknown date, after receipt of the vaccinations, the patient was taken to an unspecified hospital because "he stopped breathing for a short time", "experienced seizures", and "cried for 6 to 8 hours". On an unknown date, it was also reported that the patient had developed "a lump on his leg" that lasted for several months. The patient had sought unspecified medical attention. The outcome of the events was unknown. The reporter did not provide the relatedness of the events with PEDVAXHIB. Upon internal review the event seizure was found to be medically significant. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Death, Influenza, Pneumonia
Clinical narrative: Was diagnosed influenza A, influenza B, and pneumonia. After having a good prognosis she died. She has both influenza and pneumonia vaccines in the fall.
Age: 20.0
Sex: F
Vaccine: ADEN_4_7, FLU3, HEP, IPV, MEN, MMR, TDAP, VARCEL
Symptoms: Blindness unilateral, C-reactive protein, Lumbar puncture, Nuclear magnetic resonance imaging, Red blood cell sedimentation rate
Clinical narrative: Right eye blindness.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Differential white blood cell count, Enema administration, Full blood count, Intussusception, Metabolic function test
Clinical narrative: Intussusception reduced by air enema.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Ultrasound abdomen, Urinary system X-ray
Clinical narrative: Intussusception reduced by air enema.