chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician via a field employee referring to patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On an unspecified time, the patients received the first dose of GARDASIL or GARDASIL 9 (lot number, dose, and route not provided), and had not received second dose of any HPV product or had received second dose of any HPV product at an unspecified time one year after first dose (inappropriate schedule of vaccine administration). No adverse effects were reported. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: RUB
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a pharmacist regarding a currently 52 years old male patient. Concurrently patient was hiv positive and allergy from griseofulvin. On an unknown date years ago the patient was vaccinated with MERUVAX II (as reported unspecified rubella vaccine) dose 1, 1 time. Patient was on multiple unspecified concomitant medication. On an unknown date the patient experienced broke out in a rash all over his body. Patient contacted pharmacist to seek medical advice. The outcome of the event was reported as resolved. No PQC (product quality complaint) was involved. Causality was not reported. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a patient of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On 11-MAY-2016, the patient was administered an expired dose of RECOMBIVAX HB (Batch/lot# reported as L022261 with expire date of 01-APR-2016, dose not provided) intramuscularly. This dose of RECOMBIVAX HB was administered because when the patient was administered the original three-dose series of RECOMBIVAX HB (vaccination dates, dose, route, lot# and expiration dates were not provided) as an infant over 10 years ago, the third dose was administered before the patient was six months of age (inappropriate schedule of drug administration). This was outside the labeled recommendations in the RECOMBIVAX HB prescribing information. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
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. There was no information about the patient's concurrent conditions, concomitant therapy or medical history provided. On 09-MAY-2016, the patient was vaccinated with one dose of improperly stored PROQUAD (Merck), Lot # L041627 with expiration date of 20-APR-2017 (dose and route of administration were not reported), which was under -10 Celsius degrees for 12 hours and -14 Celsius degrees for 3 hours. There was also a previous temperature excursion of cumulative total 58 hours, 48 minutes, all in unlimited range). The cumulative temperature excursion was reported as -10 Celsius degrees for total 73 hours, 48 minutes, all in unlimited range. The temperature excursions were detected by a data logger. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapy or medical history provided. On 06-MAY-2016, the patient was vaccinated with one dose of improperly stored VARIVAX lot # L043624 with expiration date of 03-NOV-2017 (dose and route of administration were not reported), which was under -10 Celsius degrees for 12 hours and -14 Celsius degrees for 3 hours. The temperature excursions were detected by a data logger. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapy or medical history provided. On 03-MAY-2016, the patient was vaccinated with one dose of improperly stored VARIVAX lot # L043624 with expiration date of 03-NOV-2017 (dose and route of administration were not reported), which was under -10 Celsius degrees for 12 hours and -14 Celsius degrees for 3 hours. The temperature excursions were detected by a data logger. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneously in the tricep area (drug administered at inappropriate site). It was reported that the recommended area was the deltoid region. No adverse event was reported. The outcome of event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional regarding unspecified number of patients of unknown age. There was no information about concurrent condition  and historical medication. On an unknown date the patient was vaccinated with improperly stored ROTATEQ lot # L013192/expiration date-19-JAN-2017, lot # L023870/expiration date- 20-APR-2017 and lot # L035511/expiration date-19-JAN-2017 (incorrect product storage). No adverse event was reported. Temperature of exposure was 52 F, timeframe was 77 days, Temperature of exposure was 52 F, timeframe was 156 days and Temperature of exposure was 52 F, timeframe was 840 hours and call was not because of digital data logger and there was no previous excursion. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional regarding unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9, lot no. L035105/expiration date-14-MAY-2017 (incorrect product storage). No adverse event was reported. Temperature of exposure was 52 F, time frame was 840 hours and call was not because of digital data logger and there was no previous excursion. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Induration, Pain, Rash erythematous, Skin discolouration, Swelling
Clinical narrative: Red rash discoloration, Swollen and firm bump, Sore.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Influenza virus test negative, Pyrexia, Rash erythematous
Clinical narrative: Chill, fever, headache; blotchy red rash on 5-26-2016.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular, Urine analysis normal
Clinical narrative: Chill, fever, headache; blotchy red rash on 5-26-2016.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Chill, fever, headache; blotchy red rash on 5-26-2016.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin tightness
Clinical narrative: 2 inch wide by 4 inch long red firm spot that was itchy.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: Erythema at injection site extending 13 cm.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Myalgia, Pain, Pruritus, Pyrexia
Clinical narrative: Localized redness, warmth, itching, low grade fever, body ache, myalgia.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Localized redness, warmth, itching, low grade fever, body ache, myalgia.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site plaque
Clinical narrative: Indurated erythematous plaques in arm distal to administration site and pain.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure, Syncope, Tremor
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as office manager) refers to a 14 year old female patient. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 24-MAY-2016 the patient was vaccinated with first dose GARDASIL 9 (dosing details were not reported) (lot # L026602 with expiry date of 19-OCT-2017), intramuscularly. On 24-MAY-2016, 15 minutes after the patient received the GARDASIL 9, the patient collapsed in the waiting room of the physician's office and began shaking, the physician thought the patient was having a seizure. On 24-MAY-2016, after 45 minutes of receiving the GARDASIL 9 an ambulance was called and the patient was taken to an unspecified hospital due to the reaction that occurred (the patient sought medical attention). It was not stated if the patient was admitted to the hospital. The outcome of the events was unknown. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Upon internal review, seizure was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Fatigue, Influenza like illness, Local swelling
Clinical narrative: Patient received shot on 5/20 5:20 pm, pt came back on 5/21 AM had a 3" long 1" wide a red area, she saw that day the initial area was no longer red but felt bumpy and has a 2" red border around it. 5/22 saw pt initial area was blistered, and red border swollen. Sent to urgent care for prednisone and triamcinolone. Pt also had nausea and fatigue and flu like symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Patient received shot on 5/20 5:20 pm, pt came back on 5/21 AM had a 3" long 1" wide a red area, she saw that day the initial area was no longer red but felt bumpy and has a 2" red border around it. 5/22 saw pt initial area was blistered, and red border swollen. Sent to urgent care for prednisone and triamcinolone. Pt also had nausea and fatigue and flu like symptoms.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown gender and age. The patients' pertinent medical history and drug reactions/allergies were not provided. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L005301, expiration date 17-FEB-2017; lot # L010144, expiration date 24-MAR-2017; lot # L048462, expiration date 01-DEC-2017) (strength, dose and route were not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RVX
Symptoms: Diarrhoea, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a nurse regarding a 9 week old male patient. The patient's pertinent medical history included eczema. The patient did not have any concomitant medications nor drug reactions or allergies. On 16-MAY-2016, the patient was vaccinated with a dose of ROTARIX (lot A41FB541A, expiration date 26-FEB-2017, dose and route of administration were not reported). Then the patient was sent to a second clinic to receive additional vaccines that the nurse's clinic did not have in stock. The patient's father told the second clinic that the patient had not received any vaccines at the previous clinic, and the patient was inadvertently administered a second dose of an unspecified rotavirus vaccine (orally, dose and lot # were not reported). The reporter was uncertain whether the second dose of rotavirus vaccine was ROTARIX or ROTATEQ. On the same day, the patient experienced diarrhea (the patient's father called nurse's clinic to inform about the adverse event). The patient did not receive any treatment and there was no lab diagnostics and studies performed. The patient's outcome was reported as not recovered/not resolved. The relatedness between the event of diarrhea and suspect therapies was not provided. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of unspecified patients. On unspecified dates starting on or after 29-FEB-2016, the unspecified patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ, Lot K011952 with expiration date of 17-JUN-2016 and Lot L010844 with expiration date of 16-NOV-2016 (dose, route of administration were not reported), which were stored at 32.06 Fahrenheit Degree for 40 hours and 69.85 Fahrenheit Degree for 33 hours and 32 minutes. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No adverse effect was reported. 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 certified medical assistant, referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 11-MAY-2016, the patient was vaccinated with a dose of ROTATEQ (which had the lot number of K015816, expiration date 20-MAY-2016) (strength, dose, route and anatomical site of vaccination were not reported). Information regarding concomitant medication was not provided. No adverse effects were reported. Furthermore, the vaccines experienced temperature of 18.49F, the time frame was 30 days (1137 hours). The call was because a "data logger". There was not previous temperature excursion. And there was not product quality complaint involved. This is one several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's concurrent condition, medical history and concomitant therapy was unspecified. On an unknown date the patient received a dose of M-M-R II (unspecified lot # and expiration, dosage and route not provided). Subsequently, on an unspecified date the patient developed a rash and a fever. The outcome, and the causality of the events with M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 23-MAY-2016, the patient was vaccinated with a properly stored by expired dose of RECOMBIVAX HB (which had lot # reported as L006233 and expiration date 03-APR-2016; however dose, dosage number and route of administration were not reported). No adverse events reported. No product quality complain (PQC) 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history was not reported. In approximately 2016 (reported as on or after 19-JAN-2016), the patients were vaccinated with improperly stored doses of VARIVAX lot # L008270, expiration date reported as 11-MAR-2017, lot # L032396, expiration date reported as 26-AUG-2017 (dose, route and site of administration were not reported). Concomitant medications were not reported. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 5.1 Fahrenheit degrees for 8 hours 45 minutes. Data logger was not involved. There were no previous excursions 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. In approximately 2016 (reported as on or after 19-JAN-2016), the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # L024124, expiration date reported as 30-DEC-2016, lot # L040414, expiration date reported as 13-APR-2017 (dose, route and site of administration were not reported). Concomitant medications were not reported. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 5.1 Fahrenheit degrees for 8 hours 45 minutes. Data logger was not involved. There was no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown gender and age. The patient's pertinent medical history and drug reactions/allergies were not provided. On unknown dates the patients were vaccinated with improperly stored ZOSTAVAX (lot # L035504, expiration date 16-DEC-2016) (strength, dose and route were not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unknown dates the patients were vaccinated with improperly stored (at -3.2 Centigrade for 69 hours) doses of GARDASIL 9 (dose and route unknown, lot # L044475, expiration date 12-MAY-2017). There was no temperature excursion issue previously. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal discomfort, Lip swelling, Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to an approximately 12 years old female patient. The concurrent condition and medical history were none. On 03-MAR-2016 the patient saw the primary care physician who vaccinated the patient with GARDASIL 9 dose 1 (route, dose and lot details unavailable). The concomitant medications were none. On 08-MAR-2016, the patient was seen in the urgent care with abdominal complaints, itchiness, lip swelling and hives located over the trunk, arms, legs, back, abdomen and chest developed on an unspecified date in March 2016. No lab tests were done. The patient was treated with BENADRYL, prednisone (manufacturer unknown) and loratadine (manufacturer unknown). It was reported that the hives lingered intermittently for 3 days. The outcome of hives was reported as resolved on an unknown date in March 2016 and the outcome of all other events were unknown. The causality was unspecified. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown gender and age. The patients' pertinent medical history and drug reactions/allergies were not provided. On unknown dates the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # M001152, expiration date 05-JUL-2017; lot# M004893, expiration date 23-JUL-2017) (strength, dose and route were not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a male patient of unknown age. No relevant medical history or concurrent conditions were reported. Approximately in December 2015 (reported as "about 5 months ago"), the patient was vaccinated with his first dose of unidentified Merck human papillomavirus (HPV) vaccine (dose, route, lot# and expiration were unknown). On 18-MAY-2016, the patient was in the office to receive his "second" dose with GARDASIL 9 (dose, route, lot# and expiration date were unknown). The pharmacist reported that neither he nor the patient know if the first dose of vaccine the patient received was GARDASIL or GARDASIL 9. No adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Feeling abnormal, Rash generalised
Clinical narrative: This study report as received from a consumer, as part of a marketing research, refers to her daughter of unknown age. On an unknown date the patient was vaccinated with M-M-R II (dose, lot # and route were not reported). On an unknown date the patient's entire body broke out and she felt terrible for several weeks. The reporter thought this was really scary. At the time of this report, the outcome of the events was unknown. Causality was not reported. Additional information is not expected as the reporter does not wish the doctor to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unknown dates the patients were vaccinated with improperly stored (at -3.2 centigrade for 69 hours) does of PNEUMOVAX 23 (dose and route unknown, lot # M005286, expiration date 08-OCT-2017). There was no temperature excursion issue previously. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist who reported that multiple patients of an unspecified number received an improperly stored dose of GARDASIL 9 (lot # L038917, expired date 20-FEB-2018, route and dose not reported). These vaccines were under 50 F for 9 hours. There was no previously temperature excursion. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse regarding unspecified number of patients of unknown age and gender. The pertinent medical history of patients and their concurrent conditions were not reported. On an unspecified dates the patients were vaccinated with improperly stored of PROQUAD (Merck) (therapy type digital data logger) (lot # L051100, expiry date 17-JUN-2017) dosing details unknown. Concomitant medications were not reported. It was reported that the vaccines administered were subjected to temperature excursion of -6.1 degree C for a time frame of 30 minutes. The vaccines were not subjected to previous temperature excursions. The outcome of temperature excursion was reported to be supported until expiry date. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the two reports received from the same reporter. Additional information is not expected as reported did not wish to be contacted further.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age. The patient's relevant medical history, current conditions and concomitant medications were not reported. On an unknown date between March of 2016 through May of 2016, the patients were vaccinated with improperly stored pediatric and adult doses of RECOMBIVAX HB (dosing details were not reported) (lot # L048208 expiry date 15-Sep-2017 and L038018 expiry date 13-SEP-2017). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from Registered Nurse regarding unspecified number of patients of unknown age and gender. The pertinent medical history of patients and their concurrent conditions were not reported. On an unspecified dates the patients were vaccinated with improperly stored VARIVAX (therapy type digital data logger) (lot # L039093, expiry date 06-OCT-2017) dosing details unknown. Concomitant medications were not reported. It was reported that the vaccines administered were subjected to temperature excursion of -6.1 degrees C for a time frame of 30 minutes. The vaccines were not subjected to previous temperature excursions. The outcome of temperature excursion was reported to be supported until expiry date. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the two reports from the same reporter. Additional information is not expected as reporter did not wished to be contacted further.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown gender and age. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 25-MAY-2016, the patient was vaccinated with an expired dose of VAQTA (lot # J014584, expired dose: 16-JAN-2016). No symptoms 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 healthcare worker refers to multiple unspecified patients of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L038018, 13-SEP-2017) (route and dose unspecified). The vaccine was stored at 34 F for 24 hours (data logger: yes). There were no previous temperature excursions. No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On unspecified dates, the patients were vaccinated with improperly stored VAQTA (lot # L038018, Expiry: 13-SEP-2017, Lot # L032749, Expiry: 04-NOV-2016; Lot# L023232, Expiry: 25-SEP-2017) (route and dose unspecified). The vaccine was stored at 34 F for 24 hours (data logger: yes). There were no previous temperature excursions. No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L022446, Expiry: 14-FEB-2017, Lot# L026741, Expiry: 20-APR-2017) (route and dose unspecified). The vaccine was stored at 34 F for 24 hours (data logger: yes). There were no previous temperature excursions. No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, reporting that doses of GARDASIL 9 (which had the lot number of L016429, expiration date 09-AUG-2017) were improperly stored. No adverse effects were reported. Furthermore, the vaccines experienced temperature of 18.49F, the time frame was 30 days (1137 hours). The call was because a "data logger". There was not previous temperature excursion. And there was not product quality complaint involved. This is one several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Fatigue, Pain
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to two patients of unknown genders who were currently in their twenties. The patient's medical history or concurrent conditions were not reported. On an unknown date, years ago, in their pediatrician office, the patients were vaccinated with GARDASIL (dose, route, anatomical site of vaccination, lot numbers and expiration dates were not provided). Information regarding concomitant medication was not provided. On an unknown date, the patients experienced "chronic fatigue, tiredness and chronic pain. It was also reported that the mother of the two children sought medical attention with a family practice physician and there was not product quality complaint involved. At the time of reporting, the outcome of chronic fatigue and chronic pain was unknown. The causality assessment between the events and GARDASIL was not provided. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Injection site hypoaesthesia, Injection site urticaria
Clinical narrative: This spontaneous report has been received from a physician referring to a 17 year old male patient. The patient had no history of allergies and other medical history was not provided. On 12-NOV-2012, the patient received the first dose of GARDASIL (dose, route, lot number and expired date unknown). On 12-AUG-2013, the patient received the second dose of GARDASIL (dose, route, lot number and expired date unknown). There were no reactions after receiving first and second doses. On 21-APR-2016 the patient was vaccinated with GARDASIL 9 (dose 3, 0.5 ml, intramuscular, lot number and expired date unknown) (inappropriate schedule of vaccine administered and interchange of vaccine products). There was no concomitant therapy. After the third dose of GARDASIL 9 on 21-APR-2016 (inappropriate schedule of vaccine administered), the patient experienced hives at the injection site and numbness, specified to his face; these symptoms had lasted about 4 weeks and continued. No laboratory test was performed. On 19-MAY-2016, the patient visited physician's office and no treatment was employed, but she was considering recommending unspecified antihistamine. The outcome of adverse events was reported as not recovered. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Injection site pain
Clinical narrative: Severe shoulder pain where flu vaccine was administered in the left shoulder. Pain did not subside over several days. Was awakened at night with left shoulder pain. Pain has plateaued in six months but not gone away. Have sought relief with three doctor's visits, but am now being encouraged to see a specialist. Flu vaccine was administered by pharmacist standing over me while I was seated. My physician believes that the pharmacist has created a chronic bursitis situation in my left shoulder.
Age: 61.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Bursitis, Injection site pain
Clinical narrative: Severe shoulder pain where flu vaccine was administered in the left shoulder. Pain did not subside over several days. Was awakened at night with left shoulder pain. Pain has plateaued in six months but not gone away. Have sought relief with three doctor's visits, but am now being encouraged to see a specialist. Flu vaccine was administered by pharmacist standing over me while I was seated. My physician believes that the pharmacist has created a chronic bursitis situation in my left shoulder.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Rash generalised
Clinical narrative: Mother of the baby reported a rash all over the baby's body the day after the vaccination.
Age: 29.0
Sex: F
Vaccine: MMR, TD, VARCEL, MMR, TD, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash pruritic, Varicella post vaccine
Clinical narrative: Varicella given 5/18/16 -> Pt came for TB reading 5/20 and c/o generalized all over rash starting 5/19 with fever of 102 degrees. Bump noted all over face, bilateral arms and abd. Pt RTC 5/25/16 many 1-3 mm scabbed lesions covering face noted.
Age: 29.0
Sex: F
Vaccine: MMR, TD, VARCEL, MMR, TD, VARCEL
Symptoms: Pyrexia, Rash, Rash generalised, Scab, Skin lesion
Clinical narrative: Varicella given 5/18/16 -> Pt came for TB reading 5/20 and c/o generalized all over rash starting 5/19 with fever of 102 degrees. Bump noted all over face, bilateral arms and abd. Pt RTC 5/25/16 many 1-3 mm scabbed lesions covering face noted.
Age: 0.92
Sex: M
Vaccine: FLUX, IPV
Symptoms: Apraxia, Attention deficit/hyperactivity disorder, Coordination abnormal, Decreased eye contact, Depressed level of consciousness
Clinical narrative: Marked regression with coordination (falling down when previously walking very well) and eye contact (staring into space and up a lot). Less alert. For over 3 weeks. Holistic Treatment administered to help with vaccine reactions which made significant improvements. Apraxia. Speech therapy to treat apraxia. Today he has ADHD type signs and symptoms.
Age: 0.92
Sex: M
Vaccine: FLUX, IPV
Symptoms: Fall, Staring
Clinical narrative: Marked regression with coordination (falling down when previously walking very well) and eye contact (staring into space and up a lot). Less alert. For over 3 weeks. Holistic Treatment administered to help with vaccine reactions which made significant improvements. Apraxia. Speech therapy to treat apraxia. Today he has ADHD type signs and symptoms.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from an unspecified reporter via an other company's representative refers to a 38 year old female patient with allergies to amoxicillin, cephalexin, corticosteroids, loratadine (manufacturer unknown), potassium and "valulnate". On 05-APR-2016, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 injection (route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. On 05-APR-2016, reported as that same day she received the PNEUMOVAX 23, the patient developed cellulitis. The patient sought medical attention. The event was treated with unspecified intravenous antibiotics. The reporter requested a lot check for PNEUMOVAX 23, however, no lot# was provided. The outcome of the event was not reported. The relatedness between PNEUMOVAX 23 and the event was not provided. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of two reports received from the same reporter and concerning the same patient. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Pruritus, Rash
Clinical narrative: Ever since I got the Shingles Vaccine(ZOSTAVAX) I've noticed that my skin has become itchier. I had had an increase in small skin bumps, most notably on the scalp and limbs.  I'm not saying that this was caused by the vaccine, but this is what I've noticed.  Has there been any other reports of this reaction to the vaccine?
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase, Chest pain, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: Generalized pain, general inflammation, bruises on the left arm. Pain on cervical and lumbar zone, fever, fatigue, difficulty walking, high blood pressure, muscular aches, chest pain, and breathing problems. DOLOR GENERAL INFLAMACION HEMATOMAS EN EL BRAZO IZQUIERDO. DOLOR CERVICAL Y ZONA LUMBAR FIEBRE ,FATIGA ,DIFICULTAD PARA CAMINAR, PRESION ALTA, DOLOR MUSCULAR ,DOLOR EN EL PECHO Y PROBLEMA PARA RESPIRAR
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Hypertension, Injection site bruising, Laboratory test, Metabolic function test, Myalgia
Clinical narrative: Generalized pain, general inflammation, bruises on the left arm. Pain on cervical and lumbar zone, fever, fatigue, difficulty walking, high blood pressure, muscular aches, chest pain, and breathing problems. DOLOR GENERAL INFLAMACION HEMATOMAS EN EL BRAZO IZQUIERDO. DOLOR CERVICAL Y ZONA LUMBAR FIEBRE ,FATIGA ,DIFICULTAD PARA CAMINAR, PRESION ALTA, DOLOR MUSCULAR ,DOLOR EN EL PECHO Y PROBLEMA PARA RESPIRAR
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain, Pyrexia, Red blood cell sedimentation rate, Spinal pain
Clinical narrative: Generalized pain, general inflammation, bruises on the left arm. Pain on cervical and lumbar zone, fever, fatigue, difficulty walking, high blood pressure, muscular aches, chest pain, and breathing problems. DOLOR GENERAL INFLAMACION HEMATOMAS EN EL BRAZO IZQUIERDO. DOLOR CERVICAL Y ZONA LUMBAR FIEBRE ,FATIGA ,DIFICULTAD PARA CAMINAR, PRESION ALTA, DOLOR MUSCULAR ,DOLOR EN EL PECHO Y PROBLEMA PARA RESPIRAR
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: Mom described pt developing swelling, redness and hard knot of right thigh at injection site. Began to subside after one day. cool compress was recommended.
Age: 1.81
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Febrile seizures. Increased temp of 106 degrees.
Age: 48.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Burning sensation, Dizziness, Hypoaesthesia oral
Clinical narrative: Within 5 minutes of PNEUMOVAX, patient stated that she felt hot/burning sensation and difficulty breathing, back pain, dizziness. VSS with elevated BP which resolved in 5 minutes.  Lungs clear. 10:14 a.m. BP=178/120, map=139, pulse=92. 10:15 a.m., BP=140/91, map=107, pulse=88 patient placed in Trendelenburg, symptoms resolved within 5 minutes. 11: 03 a.m., BP=121/80, map=94, pulse=82, temp=97.1, lips feel numbs but no visible CLARITIN 10 mg given. No symptoms of numbness. Lungs clear.
Age: 48.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Blood pressure increased, Burning sensation, Dizziness, Dyspnoea
Clinical narrative: Within 5 minutes of PNEUMOVAX, patient stated that she felt hot/burning sensation and difficulty breathing, back pain, dizziness. VSS with elevated BP which resolved in 5 minutes.  Lungs clear. 10:14 a.m. BP=178/120, map=139, pulse=92. 10:15 a.m., BP=140/91, map=107, pulse=88 patient placed in Trendelenburg, symptoms resolved within 5 minutes. 11: 03 a.m., BP=121/80, map=94, pulse=82, temp=97.1, lips feel numbs but no visible CLARITIN 10 mg given. No symptoms of numbness. Lungs clear.
Age: 48.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling abnormal, Feeling hot, Flushing, Hypertensive crisis, Hypoaesthesia oral
Clinical narrative: Within 5 minutes of PNEUMOVAX, patient stated that she felt hot/burning sensation and difficulty breathing, back pain, dizziness. VSS with elevated BP which resolved in 5 minutes.  Lungs clear. 10:14 a.m. BP=178/120, map=139, pulse=92. 10:15 a.m., BP=140/91, map=107, pulse=88 patient placed in Trendelenburg, symptoms resolved within 5 minutes. 11: 03 a.m., BP=121/80, map=94, pulse=82, temp=97.1, lips feel numbs but no visible CLARITIN 10 mg given. No symptoms of numbness. Lungs clear.
Sex: U
Vaccine: FLU4
Symptoms: Congenital anomaly, Foetal exposure during pregnancy, Trisomy 13, Trisomy 18, Trisomy 21
Clinical narrative: This prospective pregnancy case described the occurrence of trisomy 13 in a patient. The 30-year-old mother was a subject enrolled in a open label study. The subject received Flu Seasonal QIV Dresden on 24th September 2015. Concomitant product exposures included Prenatal Vitamins and Probiotic. The mother's last menstrual period was on 9th August 2015 and estimated date of delivery was 22nd May 2016. The patient was exposed to Flu Seasonal QIV Dresden at week 6 of gestation and during the first trimester of pregnancy. The pregnancy was ongoing. The patient was diagnosed with trisomy 13. Serious criteria included congenital anomaly. Additional event(s) included trisomy 18 (serious criteria congenital anomaly), trisomy 21 (serious criteria congenital anomaly) and maternal vaccine exposure. The outcome of trisomy 13 was unknown. The outcome(s) of the additional event(s) included trisomy 18 (unknown), trisomy 21 (unknown) and maternal vaccine exposure (unknown). It was unknown if the investigator considered the trisomy 13, trisomy 18 and trisomy 21 to be related to Flu Seasonal QIV Dresden. See case US2015136932 for details regarding the mother case. Additional details were provided as follows: The patient's mother had no known relevant medical histories. The patient's mother received a dose of FLUARIX QUADRIVALENT at 6 weeks and 4 days of pregnancy. On 11th November 2015, the mother's non-invasive prenatal test (NIPT) showed trisomy 21,18, 13 which were classified as low risk. On 17th December 2015, the patient's mother's ultrasound showed an isolated echogenic focus in fetal left ventricle. Fetal cardiac anatomy appeared normal. On 10th February 2016, at 25 weeks of gestation, the follow up ultrasound showed a 4 chamber heart with echogenic focus, no further details give or follow up recommended. The pregnancy progressed normally. The baby was not yet born. The reporter did not administer the vaccine to the patient at her facility. She presumably got it elsewhere.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Headache, Influenza virus test negative, Injection site reaction, Pain
Clinical narrative: Injection site reaction Monday AM, then headache Monday PM hurt all over, no fever, 3 days after injection arm got very red went to ER and got fluids, flu swab performed (negative).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Pt. developed cellulitis of (R) thigh where shots given. Failed outpatient oral antibiotic therapy, hospitalized x 2 days for IV antibiotics, then sent home on different oral antibiotic. Cellulitis resolved.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEPAB, MNQ, PPV, TDAP
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Approx 30 min after receiving basic vaccines the patient began to break out in hives over his body. mostly on the back of his head and back of his truck though he complained of itching all over.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site haematoma, Injection site pruritus, Injection site reaction
Clinical narrative: Started out itching at injection site. Itching for worse thru out the evening of 5/27. On 5/28 the area was warm to touch and a hematoma where the injection was and around that the area was very red feeling like sunburn about a 4 in radius around the injection site. It continued to get redder and itchy. Went to urgent care on 5/28. Diagnosed with having an allergic reaction to vaccine. Was given a topical steroid and allergy medicine.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site warmth, Sunburn
Clinical narrative: Started out itching at injection site. Itching for worse thru out the evening of 5/27. On 5/28 the area was warm to touch and a hematoma where the injection was and around that the area was very red feeling like sunburn about a 4 in radius around the injection site. It continued to get redder and itchy. Went to urgent care on 5/28. Diagnosed with having an allergic reaction to vaccine. Was given a topical steroid and allergy medicine.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Affective disorder, Back pain, Chest discomfort, Chills, Cough
Clinical narrative: "Mood", rash on face, soreness in skin, chilling, cough, sore throat, swelling and pain eyes, weight loss, earache, muscle aches, leg pain, tight chest, nose pain, dry skin, itching, back pain, ringing in ears (May 15-16-2016 vomited and diarrhea). Seen my Dr. No help still have problems. Sick May 15-16-2016, May 23, 24, 2016. I have seen Family Dr, several times he said he could do nothing. Vision bad.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dry skin, Ear pain, Eye pain, Eye swelling
Clinical narrative: "Mood", rash on face, soreness in skin, chilling, cough, sore throat, swelling and pain eyes, weight loss, earache, muscle aches, leg pain, tight chest, nose pain, dry skin, itching, back pain, ringing in ears (May 15-16-2016 vomited and diarrhea). Seen my Dr. No help still have problems. Sick May 15-16-2016, May 23, 24, 2016. I have seen Family Dr, several times he said he could do nothing. Vision bad.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Myalgia, Oropharyngeal pain, Pain in extremity, Pain of skin
Clinical narrative: "Mood", rash on face, soreness in skin, chilling, cough, sore throat, swelling and pain eyes, weight loss, earache, muscle aches, leg pain, tight chest, nose pain, dry skin, itching, back pain, ringing in ears (May 15-16-2016 vomited and diarrhea). Seen my Dr. No help still have problems. Sick May 15-16-2016, May 23, 24, 2016. I have seen Family Dr, several times he said he could do nothing. Vision bad.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Rhinalgia, Tinnitus, Visual impairment
Clinical narrative: "Mood", rash on face, soreness in skin, chilling, cough, sore throat, swelling and pain eyes, weight loss, earache, muscle aches, leg pain, tight chest, nose pain, dry skin, itching, back pain, ringing in ears (May 15-16-2016 vomited and diarrhea). Seen my Dr. No help still have problems. Sick May 15-16-2016, May 23, 24, 2016. I have seen Family Dr, several times he said he could do nothing. Vision bad.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting, Weight decreased
Clinical narrative: "Mood", rash on face, soreness in skin, chilling, cough, sore throat, swelling and pain eyes, weight loss, earache, muscle aches, leg pain, tight chest, nose pain, dry skin, itching, back pain, ringing in ears (May 15-16-2016 vomited and diarrhea). Seen my Dr. No help still have problems. Sick May 15-16-2016, May 23, 24, 2016. I have seen Family Dr, several times he said he could do nothing. Vision bad.
Age: 18.0
Sex: M
Vaccine: FLU3, HEPA, HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events reported or anticipated - adult dose of Hepatitis A vaccine given to 18 yr old/should have been pediatric dose. Error found in reports review 5/24/16.