chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a 64 year old female pharmacist, who was reporting on herself. The patient's medical history and concurrent conditions were not reported. On an unknown date, a 64 year old patient was vaccinated with the first dose of GARDASIL 9 (route of administration, lot number and expiry date were not reported). Two additional doses of GARDASIL 9 were scheduled for later for pharmacist to complete the series. Concomitant therapy was not reported. No adverse effect was reported. Additional information is not expected, because there is no consent to follow up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates approximately in 2016, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L039297, expiration date: 19-JUN-2017 and lot # reported as L03527, expiration date 09-JUN-2017, following an excursion that occurred on 14-APR-2016. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 26.1 degrees Fahrenheit for 90 minutes. Data logger was involved. There were no previous temperature excursions reported. This is one of two 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 unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # L042817, expiration date: 14-JUN-2017. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 23.2 degrees Fahrenheit for cumulative time of 842.6 hours. Data logger was involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (who was also the patient's mother) via a company representative refers to a male patient of unknown age. No information regarding the patient's medical history or concurrent conditions was provided. On 29-APR-2016, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). On 16-MAY-2016 (an 18 day interval), the patient was vaccinated with the second dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient's pertinent medical history, concurrent condition and concomitant medications were not reported. On 10-MAY-2016, the patient was vaccinated with improperly stored M-M-R II (lot # was reported as L027591, expiration date 23-JUL-2107 or L030182, expiration date 11-AUG-2017). The reporter did not known which of the aforementioned lot was administered. The vaccine was exposed to a temperature of 50F for 5 hours. There was no previous temperature excursion. No adverse events reported. This is one of the two reports received 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 as received from a nurse practitioner refers to a patient of unknown age. The patient's pertinent medical history, concurrent condition and concomitant medications were not reported. On 16-MAY-2016, the patient was vaccinated with improperly stored M-M-R II (lot # was reported as L027591, expiration date 23-JUL-2017 or L030182, expiration date 11-AUG-2017). The reporter did not know which of the aforementioned lot was administered. The vaccine was exposed to a temperature of 50F for 5 hours. There was no previous temperature excursion. No adverse events reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The concurrent condition, medical history and concomitant medications were not reported. On 27-May-2016 the patient was vaccinated with an expired dose of VARIVAX (lot #K002927, Expiry: 26-FEB-2016). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. The medical history, concomitant medication and concurrent condition was not reported. On an unknown date, the patient was vaccinated with GARDASIL 9. On 09-MAY-2016, the patient experienced syncope. The patient went back to exam room for cold rags. The outcome of syncope was unknown. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to 46 patients of unknown demography. The patients' concurrent conditions, medical history and concomitant medications were not reported. The reporter stated that on unspecified dates from February 2016 to May 2016, 46 patients were vaccinated with improperly stored ZOSTAVAX (dose, frequency, route, lot # and expiration date unknown). No doses of VARIVAX were administered. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to six patients of unknown demography. The patients' concurrent conditions, medical history and concomitant medications were not reported. The reporter stated that on unspecified dates from February 2016 to May 2016, six unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (dose, frequency, route, therapy type, lot # and expiration date unknown). No doses of VARIVAX were administered. No adverse effects were reported. This is one of two reports from the same reporter. Additional has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # L033545 with expiry date on 30-MAY-2017, oral (strength and dose were not reported). No product quality complaint was involved and 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 was received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2016, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) lot # L046506 with expiry date on 17-MAY-2017, (strength, dose, route and anatomical location were not reported). No product quality complaint was involved and 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 was received from a registered nurse regarding a multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On multiple unspecified dates following a previously reported excursion, the patients were vaccinated with improperly stored VARIVAX (therapy type digital data logger) (lot # L001332, expiry date 13-JAN-2017 and Lot # L041207, expiry date 20-OCT-2017) dosing details and route unknown. Concomitant medications were not reported. The vaccine was subjected to temperature of 20.1F for a time frame of 3 hours and 27 minutes. It was reported that the vaccine was administered, since there was a previously reported excursion, with a temperature excursion of 13.5F for 3 hours and 3 minutes. Product quality complaint was not filed. No adverse effects were reported. On the other hand, the reporter stated that M-M-R II appears on the product list as temperature stability questions were asked, however, no doses of improperly stored M-M-R II were administered to any patients. This is one of the three reports received from the same reporter (MARRS #1606USA000381 and 1606USA000382). Additional information is not expected because the primary reporter did not want to be contacted.
Age: 20.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 22 year old female patient. It was reported that the patient was not pregnant. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient came to the reporter's pharmacy with a prescription for VARIVAX injection, but they did not have any in stock. Therefore, the patient was instead vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot # and expiry date were not reported) by the pharmacist. After administering the ZOSTAVAX, the pharmacist placed a call to the patient's physician and the physician reportedly said it was fine that the patient received ZOSTAVAX. There were no concomitant therapies reported. No adverse events were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Antibody test abnormal
Clinical narrative: This literature marketed report was received and refers to a 17 year old female patient. At the age of 7 years, the patient presented with recurrent pneumonias and sinusitis. Laboratory investigations at the age of 13 years showed severe panhypogammaglobulinemia associated with lymphopenia, and low B cell count in particular (severe B cell lymphopenia). The patient was started on intravenous immunoglobulin (IVIG) treatment and antibiotic prophylaxis with trimethoprim (+) sulfamethoxazole. At the age of 13 years, her short stature and small head circumference prompted investigation for a DNA repair defect. Radiosensitivity testing on peripheral blood cells was performed and the results were suggestive of ligase-4 (LIG4) syndrome. Sequencing of the LIG4 gene revealed two compound heterozygous mutations leading to immunological abnormalities. On an unknown date, the patient was vaccinated with a dose of tetanus toxoid and had protective titers of antibodies to the vaccine. On an unknown date, she was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot# and expiry date were not reported). Upon immunization, protective antibody responses were detected against only 2 of 23 serotypes. The outcome of antibody response abnormal was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). This is one of two reports received from the same literature article (cross referenced with # 1606USA000282). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of MMR II (lot # L030162, expiry date 11-AUG-2017) (doses, route and site of administration were not reported). The doses of vaccine were stored under temperature of 53.1 F for 63 hours (total of 5 excursions). There was no previous excursion. No data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash
Clinical narrative: This spontaneous report was received from a 65 year old female patient who was reporting on herself. The patient did have pertinent medical history and had an allergy to unspecified topical product. The patient's concomitant therapies included BENICAR, calcitonin and tobia (unspecified). On 26-MAY-2016, the patient was vaccinated with a doze of ZOSTAVAX (dose, route of administration and lot # were not reported). On 20-MAY-2016 (three days after receiving ZOSTAVAX), the patient developed three "spots" on her legs and redness near the injection site. The patient sought medical attention via speaking with a specialist. The patient was placed on valacyclovir by a physician to mitigate the symptoms. There was no lab diagnostics and studies performed. The patient's outcome was reported as recovering/resolving. The relatedness between the events and the therapy with ZOSTAVAX was not provided. Additional information is not expected as there was no consent to contact a healthcare professional.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Exposure during pregnancy, Pregnancy test urine negative
Clinical narrative: This spontaneous prospective pregnancy report was received from registered nurse concerning a female patient of unknown age. No concurrent conditions or medical history were reported. On 19-MAY-2016, the patient was vaccinated with GARDASIL 9 (dose, Lot No., expiration date, route and anatomical location of administration were not reported). Other suspect therapies included MENACTRA. On an unknown date, reported as prior to receipt of GARDASIL 9 was administered a urine pregnancy test to the patient with result was negative. The reporter stated that shortly after this the patient found she was pregnant and also that according to the "pregnancy wheel", the patient conceived on 02-MAY-2016. The nurse noted that the patient was pregnant at the time she received the GARDASIL 9 and MENACTRA. The last menstrual period (LMP) was of 18-APR-2016 and estimated date of delivery (EDD) of 23-JAN-2017. The pregnancy outcome was pending. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 7 year old patient of unknown gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unspecified time, the patient was vaccinated with the first dose of hepatitis a vaccine (Manufacturer unknown), which was followed, 4 months and 5 days later, by a second booster dose (the dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 28-SEP-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 14 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 01-SEP-2015, the patient was vaccinated with ZOSTAVAX (0.5 ml, Lot#L013284, expiration date: 07-AUG-2016), which was improperly stored for 19 days (Incorrect product storage and incorrect dose administered). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 30-SEP-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 16 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M009377, expiry date 17-JUN-2017) (doses, route and site of administration were not reported). The doses of vaccine were stored under temperature of 53.1 F for 63 hours (total of 5 excursions). There was no previous excursion. No data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Antibody test abnormal
Clinical narrative: This literature marketed report was received from the authors of the published literature article and refers to a 12 year old female patient. The patient had no significant history of infections and had normal growth (normal height and weight and an occipital frontal circumference on the 25th percentile). Sequencing of the ligase-4 (LIG4) gene revealed two compound heterozygous mutations leading to immunological abnormalities and severe B cell Lymphopenia was observed. On an unknown date, the patient was vaccinated with a dose of tetanus toxoid and had protective titers of antibodies to the vaccine. On an unknown date, she was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported). Upon immunization, protective antibody responses were detected against only 5 of 23 serotypes. The outcome of antibody response abnormal was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). This is one of two reports received from the same literature article (cross referenced with MARRS# 1605USA011761). 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 registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot # L014878 with expiry date on 17-JAN-2018, (strength, dose, route and anatomical location were not reported). No product quality complaint was involved and no adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Patient reports redness, swelling, pain from bicep area of arm injected extending to the elbow. Symptoms began to resolve after 48 hrs. Patient did not seek medical care.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot # L014878 with expiry date on 17-Jan-2018, (strength, dose, route and anatomical location were not reported). No product quality complaint was involved and 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: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blister, Full blood count, Pruritus, Rash, Urticaria
Clinical narrative: Pt developed blisters/rash, hives, spread thru entire body, pt up day and night itching, raw skin. No clear diagnosis. No improvement any meds or creams. New blisters/swelling appears still at 2 weeks. 6-1-16 - responded to acyclovir topically.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a patient who received BEXSERO (batch number 149001A, expiry date 30th September 2016). On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe arm pain after vaccination. The representative did not have any patient identifiers.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of PROQUAD (Merck) lot # L002418 with expiration date of 23-JUL-2016 (anatomical route of vaccination and dose number were not provided). The Medical Assistant started that PROQUAD (Merck) was exposed to a temperature excursion of 37.2 degree F for 15 hours. Additionally, the vaccine was not involved on a previous temperature excursion. The call was made due to a data logger. Furthermore, no adverse events were reported and no product quality issue was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Mass, Skin warm, Tenderness
Clinical narrative: Large, red, hot lump. Very tender. Noted Tuesday (05/17/16), worse on Wednesday. Pt applied ice and took ADVIL 400 mg. Not any better. Pt was told to continue to ice. Prescribing cephalexin capsule, 250 mg, 1 cap, orally, TID, 7 days, 21.
Age: 73.0
Sex: F
Vaccine: RAB
Symptoms: Body temperature increased, Pain, Somnolence
Clinical narrative: Case number PHEH2015US011125, is an initial spontaneous report received from a physician on 08 Jun 2015. This report refers to a 73 year old female patient. Historical condition was not reported. Concurrent condition included a bat bite. She received the second dose of RABAVERT (batch number: not reported) for post-exposure on 02 Jun 2015 at 11:00 AM. After the shot, she took some rest and then went to work. On the same day, around 9:00 PM, she developed a body temperature of 100.2 degree Fahrenheit. She also experienced body ache and sleepiness. The next morning she felt fine after treatment with TYLENOL. She was not hospitalized. Final outcome, seriousness and causality of the events were not reported.
Age: 1.06
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a physician via a company representative refers to a 12 month old male patient. No concurrent condition or medical history was reported. Concomitant therapies included VAQTA pediatric and PREVNAR. On 10-MAY-2016 during the patient's one year check up, the patient was vaccinated the first dose of a two dose series with an expired dose of VARIVAX (lot # J008522 with expiration date of 10-JUL-2015, 1 shot, subcutaneous). Other suspect therapy included MMRII (dose and route unknown) since an unspecified date. No adverse experience was reported. No treatment was given to the patient. The patient did not seek medical attention. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, FLUX
Symptoms: Chills, Diarrhoea, Dizziness, Malaise, Nausea
Clinical narrative: 67 YO patient presented for f/up post discharge for symptoms of dizziness and syncope. Patient was administered vaccine and came back next day complaining of n/v/d, malaise and chills.
Age: 67.0
Sex: M
Vaccine: PPV, FLUX
Symptoms: Syncope, Vomiting
Clinical narrative: 67 YO patient presented for f/up post discharge for symptoms of dizziness and syncope. Patient was administered vaccine and came back next day complaining of n/v/d, malaise and chills.
Age: 67.0
Sex: M
Vaccine: PPV, FLUX
Symptoms: Myalgia
Clinical narrative: 67 YO patient presented for f/up post discharge for symptoms of dizziness and syncope. Patient was administered vaccine and came back next day complaining of n/v/d, malaise and chills.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Rash
Clinical narrative: This spontaneous report concerning a female patient, who is currently 63 years old, was received from the patient herself. Her concurrent conditions included diabetes and cholesterol. However, information regarding her medical history and drug reactions/allergies were unspecified. On 26-SEP-2013, the patient was vaccinated with a single shot of ZOSTAVAX (the dose, dosage number, frequency, route of administration, anatomical location, lot # and expiration date were not reported). Her concomitant therapies included JANUMET, CRESTOR and LEXAPRO. Subsequently, on an unknown date the patient developed bumps on the right side of her face along with a bed head pain. Therefore, she contacted her physician and sought medical attention via an office visit. The physician recommended that she wait for a couple of days to see if the bumps went away. However, on 14-MAY-2016, she went to an urgent care and was diagnosed with shingles. As a result, she was treated with prednisone (Manufacturer unknown) for five days. Notably, no product quality complaint was involved. At the time of reporting, the shingles remained having unresolved. The patient failed to provide a causal relationship between the event and the vaccination with ZOSTAVAX. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEPAB
Symptoms: Muscular weakness
Clinical narrative: Pt reports weakness in left arm after TWINRIX injection that lasted 2 days. This shot was given 8/25/2014 and was just reported today.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Swelling, pain, redness at injection site. Chills, fever, pain, lethargy.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Swelling, pain, redness at injection site. Chills, fever, pain, lethargy.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Cold sweat, Dry skin, Pallor, Syncope
Clinical narrative: Syncope episode after MENACTRA vaccine admin. Placed head between knees, gave cool compress, with immediate improvement. Color pale, skin moist. 10:33 B/P 81/49 P. 44 10:36 B/P 106/74 P. 53 10:45 B/P 111/77 P. 55 Color pink, skin dry - stated feeling "OK now".
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Body temperature increased, Diplopia, Dizziness, Feeling abnormal, Injection site erythema
Clinical narrative: Came into office 5/23/16 at 4:30 p.m. Received BEXSERO Meningococcal Group B vaccine 1 single dose (0.5 ml). This was his second in the series. # 1 was given on 4/22/16. About 6:30 p.m. he started felling light headed and dizzy. Ran a temp of < 101, arm was warm and red where vaccine given. The following day 5/24/16 he still "felt off" per mom. Did also report some double vision. Seen later in our office on 5/24/16 and states arm was less painful temp 99.5 pulse 68, BP 118/64. Still little "motion sickness". No fevers since Tue. Per mother 5/26/16 (back to school).
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site warmth, Motion sickness, Pain in extremity
Clinical narrative: Came into office 5/23/16 at 4:30 p.m. Received BEXSERO Meningococcal Group B vaccine 1 single dose (0.5 ml). This was his second in the series. # 1 was given on 4/22/16. About 6:30 p.m. he started felling light headed and dizzy. Ran a temp of < 101, arm was warm and red where vaccine given. The following day 5/24/16 he still "felt off" per mom. Did also report some double vision. Seen later in our office on 5/24/16 and states arm was less painful temp 99.5 pulse 68, BP 118/64. Still little "motion sickness". No fevers since Tue. Per mother 5/26/16 (back to school).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling, bruising, lasting more than 5 days. Saw physician, no treatment given. (At injection site).
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased appetite, Diarrhoea
Clinical narrative: Patient was given ROTATEQ oral vaccine on 5-5-16. Pt. has had 12 days of frequent loose BM's and having decrease in appetite.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt. came into pharmacy on 5/23/16 C/O general pain in her arm where the ZOSTAVAX inj was given on 4/18/16. She wasn't sure if it was actually from immunization of it she hurt her arm. Pt was also referred to MD.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Irritability, Pyrexia, Somnolence
Clinical narrative: Fever of over 100 degrees for three days after administration. Blood in stool beginning lasted 7 days after administration of ROTATEQ. Blood in stool lasted for 5 days. Baby was very fussy and sleeping more.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Joint range of motion decreased, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: After receiving injection, patient had tingling sensation, severe arm pain and limited ROM lasting x 1 week. Spiked temp of 103 the night of vaccine - resolved with ibuprofen.
Age: 0.42
Sex: M
Vaccine: HEPA, HIBV, PNC13, HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given a Hep A vaccine at 5 months of age. No adverse reaction was observed.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Large asymmetrical rash over 1 inch radius at injection site warm, mildly painful.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Significant swelling from shoulder to elbow "twice normal size", redness, hot to touch, pain/very tender to the touch, itchy at times. Symptoms started within a couple hours of injection. Started to improved 5/24/16.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Significant swelling from shoulder to elbow "twice normal size", redness, hot to touch, pain/very tender to the touch, itchy at times. Symptoms started within a couple hours of injection. Started to improved 5/24/16.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Induration
Clinical narrative: 24 hours after vaccine - 5 cm x 5 cm erythema with 2.5 cm induration.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Erythema, warmth, swelling. Diphenhydramine 25 mg once, Clindamycin 300 mg tid.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Lip swelling
Clinical narrative: Patient received TDAP vaccine on 12/29/15. On 12/30/15, patient phoned clinic and told nurse that her lips were swollen. Denied difficulty breathing or swallowing. Patient was advised to take Diphenhydramine 25 to 50 mg PO Q6H PRN. Was also instructed to call 911 with any difficulty breathing or swallowing. Per nursing visit note 12/31/15, patient reported improvement in lip swelling with diphenhydramine and denied difficulty breathing or swallowing.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Rash, Rash macular
Clinical narrative: C/O rash to both arms and redness at injection site, w/itching few hrs. after TDAP administration. Exam, macular rash scattered bilt. arm of mild erythema, no vesicles. Erythema also at injection site (left deltoid) no blisters. Tx: Antihistamine oral, hydrocortisone topical. Started tx today 6/1/16.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Rash
Clinical narrative: Rash from neck to knees/front and back torso. Antihistamine taken for rash. TYLENOL taken for soreness at injection site.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Headache, Malaise, Myalgia, Pain in extremity
Clinical narrative: Got MENACTRA on right arm and TRUMENBA left arm on 5/31/16. But got sick next day, with low grade fever, muscle ache, headache, dizziness, and left arm swollen and painful.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Got MENACTRA on right arm and TRUMENBA left arm on 5/31/16. But got sick next day, with low grade fever, muscle ache, headache, dizziness, and left arm swollen and painful.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, 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 02-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 (route of administration, lot #, expiration date, dose, dosage number and anatomical location were unknown). Subsequently, on 13-MAY-2015, the patient was vaccinated with a dose of PREVNAR (route of administration, lot #, expiration date, dose, dosage number and anatomical location were unknown) and on 17-MAY-2016, the patient was vaccinated with a second dose of PNEUMOVAX 23 (which had a lot # reported as K021881 and expiration date 30-JUL-2016; however dose, dosage number and route of administration were not reported). No adverse effect reported. No product quality complain (PQC) was involved. 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 registered nurse regarding a multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (therapy type unspecified) (lot # L041629, expiry date 22-APR-2017 and lot # L051101, expiry date 17-JUN-2017) dosing details was unknown. Concomitant medications were not reported. Temperature excursion and time frame were not provided. Product quality complaint was not filed. No adverse effects were reported. This is one of the three reports received from the same reporter (MARRS # 1605USA012070 and 1606USA000381). Additional information is not expected because the primary reporter did not want to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L045953 exp date 17-NOV-2017 and lot # L045954 exp date 17-NOV-2017) (route not reported). The vaccines were stored at a temperature of 6.5F for a time frame of 28 minutes. The previous temperature excursion was 7F for 22 minutes and 7.5F for 23 minutes. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On unspecified dates, the patients received improperly stored doses of GARDASIL with a lot # L039066 and expiration date of 19-MAR-2017, (strength, route of administration and dose were not provided). There was no concomitant therapy reported. No adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.31
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Otitis media, Pyrexia, Rash, Vomiting
Clinical narrative: (No check-ups since 4 mos of age). Pt seen in office for 15 mo check-up on 5-19-16. Behind on imm. Fever (103 degrees max), vomiting, loose stools began approximately 05-27-16. Rash began approximately 2 days ago. Also dx'd with BOM at 5-31-16 O.V. For above s/s (questionable viral-vs-secondary to MMR given 5/19/16).  TX with AMOXIL 400/5x10 d for BOM.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, 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 an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (concentration, dose, route of administration, lot number and expiration date were not reported). Concomitant medications were not provided. On an unknown date, the patient received a second dose of ZOSTAVAX. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 23-SEP-2015, the patients were vaccinated with ZOSTAVAX (0.67 ml, Lot #L024997, expiration date: 06-OCT-2016), which were improperly stored for 9 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 27-AUG-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot #L016284, expiration date: 07-OCT-2016), which were improperly stored for 14 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 17-SEP-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot #L024997, expiration date: 06-OCT-2016), which were improperly stored for 3 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored ROTATEQ orally (therapy type digital data logger) (lot # L035511, expiry date 21-MAY-2017) dosing details was unknown. Concomitant medications were not reported. The vaccine was subjected to temperature of 65.9F for a time frame of 4 hours and 20 minutes. It was reported that the vaccine was administered, since there was a previously reported excursion, with a temperature excursion of 54.9F for 3 hours. Product quality complaint was not filed. No adverse effects were reported. This is one of the three reports received from the same reporter (MARRS #1605USA012070 and 1606USA000382). Additional information is not expected because the primary reporter did not want to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 26-AUG-2015, the patient was vaccinated with ZOSTAVAX (1 ml, Lot #L016284, expiration date: 07-AUG-2016), which were improperly stored for 13 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 6 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 21-SEP-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot #L024997, expiration date: 06-OCT-2016), which were improperly stored for 13 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 28-AUG-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot #L016284, expiration date: 07-AUG-2016), which were improperly stored for 15 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medications or drug allergies/drug reactions reported. On 25-AUG-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L016284, expiration date: 07-AUG-2016), which was improperly stored for 12 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 4 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 31-AUG-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot #L016284, expiration date: 07-AUG-2016), which were improperly stored for 18 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 01-OCT-2015, the patient were vaccinated with ZOSTAVAX (0.65 ml, Lot#L024997, expiration date: 06-OCT-2016), which were improperly stored for 17 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 29-SEP-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot #L024997, expiration date: 06-OCT-2016), which were improperly stored for 15 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 16-SEP-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 2 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 22-SEP-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot #L024997, expiration date: 06-OCT-2016), which were improperly stored for 8 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Hyperhidrosis, Pain
Clinical narrative: Patient experienced lightheadedness, headache and sweating, pain soon after the vaccination.